GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 12427-38-2 |
| Chemical Name | Manganese N,N'-ethylenebis(dithiocarbamate) [Maneb] |
| Substance ID | H29-B-116 |
| Classification year (FY) | FY2017 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2006 |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| UN GHS document (External link) | UN GHS document |
| Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
| Model Label by MHLW (External link) | |
| Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Solid (GHS definition). |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Solid (GHS definition). |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Solid (GHS definition). |
| 6 | Flammable liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 7 | Flammable solids | Classification not possible |
- |
- | - | There is the information that it is combustible (ICSC (J) (2003)), but the classification is not possible due to no data. |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | Because maneb or maneb preparation with not less than 60 weight % maneb is classified in Division 4.2, Subsidiary risk 4.3, PGIII in UNRTDG (UN 2210), it does not correspond to pyrophoric solids, hazard class with the highest precedence. |
| 11 | Self-heating substances and mixtures | Category 2 |
 Warning |
H252 |
P235+P410
P280 P407 P413 P420 |
Maneb or maneb preparation with not less than 60 weight % maneb is classified in Division 4.2, Subsidiary risk 4.3, PGIII in UNRTDG (UN 2210). |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Category 3 |
Warning |
H261 |
P231+P232
P370+P378 P402+P404 P280 P501 |
Maneb or maneb preparation with not less than 60 weight % maneb is classified in Division 4.2, Subsidiary risk 4.3, PGIII in UNRTDG (UN 2210). Besides, maneb, stabilized one or maneb preparation, stabilized one against self-heating is classified in Division 4.3, PGIII in UNRTDG (UN 2968). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | The following seven LD50 values for rats are reported: 3,000 mg/kg, 4,400 mg/kg (HSDB (Access on August 2017)), 4,500 mg/kg (EHC 78 (1988)), 6,750 mg/kg (EHC 78 (1988), HSDB (Access on August 2017)), 7,950 mg/kg (males), 8,780 mg/kg (females) (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 14 (Japan Crop Protection Association, 1993)), and > 5,000 mg/kg (EPA Pesticide (2005)). All of these values correspond to "Not classified" (three of which correspond to Category 5 in the UN GHS classification). From the above, it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Two LD50 values for rabbits are reported of > 2,000 mg/kg (EPA Pesticide (2005)) and > 5,000 mg/kg (HSDB (Access on August 2017)), and both correspond to "Not classified." An LD50 value for rats of > 5,000 mg/kg (HSDB (Access on August 2017), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 14 (Japan Crop Protection Association, 1993)) is reported and corresponds to "Not classified." From the above, it was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Agricultural Chemical Registration Data (2005) used in the previous classification were not used because they could not be obtained and confirmed. LC50 values for rats of > 1.3 mg/L (EPA Pesticide (2005)) and > 3.83 mg/L (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 14 (Japan Crop Protection Association, 1993)) are reported, but both reports were not adopted because there is no description of exposure time. As there was no other information on LC50 values, it was classified as "Classification not possible." Therefore, the classification result was changed from the previous classification. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, there is a description that it is not a skin irritant (EPA Pesticide (2005)). Also, it is listed as a chemical substance that causes skin disorders in "Simple chemical substances or compounds designated by the Minister of Health, Labour and Welfare or disease designated by the Minister of Health, Labour and Welfare based on Appended Table 1-2, (iv) 1 of the Ordinance for Enforcement of the Labor Standards Act." Agricultural Chemical Registration Data (1970) which was adopted as the rationale for the previous classification could not be obtained. Therefore, the classification was changed on the basis of information obtained for this survey. |
| 3 | Serious eye damage/eye irritation | Category 2A |
 Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
In an eye irritation test with rabbits (OECD TG 405 compliant), redness and edema were observed in all six animals on 1, 2, 3 days after application to conjunctiva, but two animals did not recover by day 7, and the eye irritation index MMAS (Modified Maximum Average Score, equivalent to AOI, maximum value 110) was 14.3 (ECETOC TR48 (1998)). In addition, in another study with rabbits, redness and edema were observed in all animals in the no-washing group at 24 hours following application of this substance, and diffuse hyperemia and swelling with ectropion of the eyelid occurred, but all of these disappeared after 6 days. Meanwhile, redness and edema were observed in all animals in the washed group, but they disappeared after 2 days and 8 days, respectively. Based on the above, it is described that this substance was considered to be irritating to the eye (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 14 (1993)). Therefore, it was classified in Category 2A. Agricultural Chemical Registration Data (1985) which was adopted as the rationale for the previous classification could not be obtained, and were therefore not used. Besides, this substance was classified as "Eye Irrit. 2, H319" in the EU CLP classification (ECHA CL Inventory (Access on August 2017)). |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
It is described that this substance was strongly sensitizing in a maximization test with guinea pigs (Contact Dermatitis (5th ed. (2011), Frosch)). Also, there are descriptions that in patch tests with three volunteers in whom adverse events occurred at the facilities handling this substance, skin sensitization by this substance was shown (HSDB (Access on August 2017)), and that in human cases, 12 of 18 persons who used this substance alone or the health effects of whom were judged to be due to this substance, developed rashes after exposure to field residue, indicating the skin sensitization of this substance (EPA Pesticide (2005)). Therefore, it was classified in Category 1. Agricultural Chemical Registration Data (2005) which was adopted as the rationale for the previous classification could not be obtained, and were therefore not used. Besides, this substance was classified as "Skin Sens. 1, H317" in the EU CLP classification (ECHA CL Inventory (Access on August 2017)). |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - |
It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government. As for in vivo, it was negative in a dominant lethal test with mice, negative in a micronucleus test with mice (organ not described), and negative in chromosome aberration tests with bone marrow cells of rats, mice, and Chinese hamsters (JMPR (1993)). As for in vitro, bacterial reverse mutation tests were positive and negative results, a gene mutation test with Chinese hamster ovary (CHO) cells was negative, and a sister chromatid exchange test with Chinese hamster ovary (CHO) cells was weakly positive (EHC 78 (1988), HSDB (Access on August 2017), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 14 (1993), JMPR (1993)). It is concluded in JMPR that this substance is not genotoxic (JMPR (1993)). Besides, Agricultural Chemical Registration Data described in the previous classification could not be confirmed. |
| 6 | Carcinogenicity | Category 2 |
 Warning |
H351 |
P308+P313
P201 P202 P280 P405 P501 |
There is no report on the carcinogenicity of this substance in humans. As for experimental animals, in studies with two strains of mice orally dosed (dosed by gavage at 46.4 mg/kg/day up to 4 weeks of age, then dosed by feeding at 158 ppm up to 78 weeks of age), no increase in the incidence of tumors was observed, but in another study in which mice were dosed by gavage at 500 mg/kg/day for 9 months, a significant increase in lung adenomas was seen (IARC 12 (1976), EHC 78 (1988)). In addition, an increased incidence of hepatocellular adenomas and alveolar epithelial adenomas in the lung was observed at 2,400 ppm also in a study in which mice were dosed by feeding at up to 2,400 ppm for 18 months (HSDB (Access on August 2017), EPA Pesticide (2005)). Meanwhile, it is reported that in a lifetime study in which rats were dosed by gavage at 335 mg/kg/day, after 22 months, only one case of subcutaneous rhabdomyosarcoma and another case of mammary carcinoma were observed (IARC 12 (1976)), but in a study in which rats were dosed by feeding at up to 2,500 ppm for two years, adenoma-like tumors in the thyroid at 1,250 ppm, and adenoma and carcinoma in the thyroid at 2,500 ppm were observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 14 (1993)). As for classifications by other organizations, IARC classified it in Group 3 (IARC Suppl. 7 (1987)) and EPA in Group B (Probable human carcinogen) (Chemicals Evaluated for Carcinogenic Potential: Annual Cancer Report (2016); evaluated in 1999). From the above, from the classification result by EPA, which was based on a more recent evaluation than the classification result by IARC, Category 1B is supported. However, given that most of the findings from studies with two species of experimental animals were increased incidences of benign tumors, the evidence for carcinogenicity in experimental animals was considered to be limited rather than sufficient. Therefore, the proper classification for this hazard class is judged to be Category 2. Besides, since information sources different from those in the previous classification were used, the classification result was changed. |
| 7 | Reproductive toxicity | Category 1B |
Danger |
H360 |
P308+P313
P201 P202 P280 P405 P501 |
There is a report that there were no effects on reproductive indices at doses of up to 250 ppm in a three-generation study with rats dosed by feeding, but that in a study in which rats were orally dosed with this substance at 14-700 mg/kg/day for 4.5 months, effects on the genetic organs were observed in all dose groups, and an decrease in fertility occurred (EHC 78 (1988), HSDB (Access on August 2017)). Meanwhile, it is reported that in a single oral dose study with pregnant rats given at 1,000-4,000 mg/kg on gestational day 11-13, malformations in the facial part of the skull, caudal vertebrae, palates, limbs, and tails were observed. Similarly, there is a report that in a single oral dose study with pregnant rats given at 400-1,420 mg/kg on gestational day 11, cleft palate, hydrocephaly, and other malformations were observed at or above 770 mg/kg/day. In addition, there is a report that also in a study in which pregnant rats were dosed at 480 mg/kg/day during the organogenesis period (gestational day 7-16), hydrocephalus in the fetuses was observed (EHC 78 (1988), HSDB (Access on August 2017)). On the other hand, in a study with pregnant mice dosed at up to 1,500 mg/kg/day during the organogenesis period, delayed ossification only and no malformations were observed in the fetuses at up to 1,500 mg/kg/day where maternal toxicity was observed (EHC 78 (1988), HSDB (Access on August 2017)). Other than these, Japan Society for Occupational Health (JSOH) classified manganese and manganese compounds in Group 2 Reproductive Toxicants (Recommendation of Occupational Exposure Limits (2017)). From the above, in reproductive and developmental toxicity studies with rats, while there were no descriptions of general toxicity effects in parental animals, effects on the genetic organs and the fertility of the parental animals, and the occurrence of malformations in the fetuses were observed. Based on this and the classification result by Japan Society for Occupational Health (JSOH), this substance was classified in Category 1B for this hazard class. Besides, EU classified this substance as "Repr. 2" (ECHA CL Inventory (Access on August 2017)). Since information sources different from those in the previous classification were used, the classification result was changed. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | Classification not possible due to lack of data. It is reported that in a test with rats, with a single oral dose of this substance, and Zineb (CAS RN 12122-67-7) or Mancozeb (CAS RN 8018-01-7) which are other dithiocarbamate pesticides, sedation, adynamia, decreased tonus, disturbances in coordination, paresis, paralysis of the limbs, general weakness, lack of appetite, and prostration were observed in a dose-dependent manner (EHC 78 (1988)). However, this information was not adopted as there was no description of the doses, and details were unknown. In addition, information in Agricultural Chemical Registration Data (1974) cited in the previous classification could not be obtained and therefore, could not be confirmed. As there was no other information available as rationale, it was classified as "Classification not possible." |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, thyroid), Category 2 (pituitary, kidney) |
Danger Warning |
H372
H373 |
P260
P264 P270 P314 P501 |
As for humans, while the effects could not be definitively attributed to this substance alone, it is reported that as a result of a comparison of peripheral and autonomic nerve functions between a group of 131 Dutch bulb farmers chronically exposed to mixed pesticides (including zineb and this substance) and a control group of 67, decreases in both autonomic and peripheral nerve functions were shown depending on the exposure levels (CICAD 12 (1999)). Fifty agricultural workers in Brazil who had had contact with this substance (preparation or fumigant) for at least 6 months developed muscular rigidity with cogwheel phenomenon in high frequency as well as headache, fatigue, nervousness, memory disorder, and sleepiness. However, it is reported that in both studies, the subjects were also exposed to other substances, so the effects may not be attributable to this substance alone (CICAD 12 (1999)). In addition, it is reported that two young Brazilian agricultural workers developed Parkinsonian syndrome, and a 37-year-old Italian man developed Parkinsonism after chronic dermal and inhalation exposure (CICAD 12 (1999)). In addition, it is not this substance, but it was described that by excess exposure to manganese compounds by the oral or inhalational route, as chronic effects, symptoms of manganese poisoning similar to Parkinson's disease, such as gait disturbance and speech disorder were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). There are also reports of manganism (neurological and neuropsychiatric symptoms that can lead to Parkinsonism-like symptoms) due to occupational exposure to manganese compounds and occurrence of manganism-like symptoms due to exposure via drinking water (CICAD 12 (1999)). As for experimental animals, effects mostly on the thyroid were seen in studies with various animals. Among them, there is a report that in a 13-week study with dogs dosed by feeding, hyperplasia of the follicular epithelial cells in the thyroid was observed at 400 ppm (converted guidance value: 10 mg/kg/day) within the guidance value range for Category 1 (JMPR (1993)). In a 13-week study with rats dosed by feeding, degeneration of the tubular epithelium in kidney and increased colloid in the thyroid follicles were observed at or above 250 ppm (converted guidance value: 12.5 mg/kg/day) within the guidance value range for Category 2. In addition, there is a report that in another 13-week study with rats dosed by feeding, reduced body weight gain at or above 500 ppm (converted guidance value: 25 mg/kg/day) within the guidance value range for Category 2, and hypertrophy and hyperplasia of the follicular epithelium in the thyroid, decreased colloid in the thyroid follicles, and focal or multifocal proliferation of basophilic cells in the anterior lobe of the pituitary at or above 1,250 ppm (converted guidance value: 62.5 mg/kg/day) were observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 14 (Japan Crop Protection Association, 1993)). From the above, effects on the nervous system, which could not be definitively attributed to this substance alone, were suggested in humans. In addition, this substance contains manganese, which was suggested to affect the nervous system. For experimental animals, effects were observed on the thyroid and also on the pituitary and kidney. The finding in the pituitary is considered to be indicative of increased production of thyroid-stimulating hormone (TSH). Therefore, it was classified in Category 1 (nervous system, thyroid) and Category 2 (pituitary, kidney). Besides, since Agricultural Chemical Registration Data (1974, 2005) was not obtained, the classification result was different from the previous classification. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 1 |
 Warning |
H400 |
P273
P391 P501 |
From 96-hour EC50 = 0.003 mg/L for crustacea (Mysid shrimp) (EPA RED: 2005), it was classified in Category 1. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 |
P273
P391 P501 |
If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 1% (J-CHECK, 2005)), and 96-hour NOEC (biomass) = 0.001 mg/L for algae (Chlorella pyrenoidosa) (EPA AQUIRE: 2017, Ma, J. P. et al. (2007)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 1% (J-CHECK, 2005)), and 96-hour EC50 = 0.003 mg/L for crustacea (Mysidopsis bahia) (EPA RED: 2005). From the above results, it was classified in Category 1. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
|
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |