Item | Information |
---|---|
CAS RN | 84-74-2 |
Chemical Name | Di-n-butyl phthalate |
Substance ID | m-nite-84-74-2_v2 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | To Guidance List |
UN GHS document (External link) | To UN GHS document |
FAQ(GHS classification results by the Japanese Government) | To FAQ |
List of Information Sources (Excel file) | List of Information Sources |
List of Definitions/Abbreviations | Definitions/Abbreviations |
Sample Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Sample SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | To OECD/eChemPortal (External link) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
6 | Flammable liquids | Not classified |
- |
- | - | A flash point is 157 deg C (closed cup) (HSDB (Access on July 2013)) above 93 deg C. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
7 | Flammable solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 402 deg C (HSDB (Access on July 2013)). | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
10 | Pyrophoric solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid substances are not available. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified (Not applicable) |
- |
- | - | The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
17 | Desensitized explosives | - |
- |
- | - | - | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Not classified |
- |
- | - | It was classified as "Not classified" based on LD50 by oral administration for rats of 6,300 mg/kg (EU-RAR (2004)) and 8,000 mg/kg (EU-RAR (2004), PATTY (6th, 2012)). Besides, it is described that in a human case of a 23-year-old male worker who accidentally ingested about 10 g, he developed vomiting, dizziness, and a few hours later, lacrimation, pain in the eyes, and severe keratitis. And urinalysis showed microhematuria, oxalate crystals, and leukocytes (EU-RAR (2004)). | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | It was classified as "Not classified" based on LD50 by dermal administration for rabbits of >= 4,000 mg/kg (EHC 189 (1997)) and > 20,000 mg/kg (EU-RAR (2004), PATTY (6th, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Not classified |
- |
- | - | It was classified as "Not classified" based on LC50 (mist) of >= 15.68 mg/L for rats (EU-RAR (2004)). Besides, based on the description of an aerosol inhalation test, a reference value in the unit of mg/L as a mist was applied for the classification. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | It is described in the Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EU-RAR (2003) that skin irritation was observed, but it is described in EU-RAR (2004) (Addendum to the Environmental Section), which is an addendum to EU-RAR (2003), that a test according to OECD TG404 resulted in no irritation, and it is concluded in EU-RAR (2004) that there was no irritation. Therefore, it was classified as "Not classified" (Category 3 in UN GHS classification). | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | It is described in the Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EU-RAR (2003) that eye irritation was observed and disappeared after 48 or 72 hours, but it is described in EU-RAR (2004) (Addendum to the Environmental Section), which is an addendum to EU-RAR (2003), that a test according to OECD TG405 resulted in no irritation, and it is concluded in EU-RAR (2004) that there was no irritation. Therefore, it was classified as "Not classified" (Category 3 in UN GHS classification). | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
4 | Skin sensitization | Category 1 |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
From descriptions in EU-RAR (2004), EHC 189 (1997), dibutyl phthalate did not show skin sensitization in animal tests, but there is a result suggesting that it is positive in case reports in humans. It was classified in occupational skin sensitizers Group 2 in the Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2012), and the Special Committee of the Japanese Society of Occupational and Environmental Allergy (2004) classified it as being sensitizing to the skin. Therefore, it was classified in Category 1. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
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, a negative result is reported in a micronucleus test with mouse peripheral blood erythrocytes (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EHC 189 (1997), EU-RAR (2004)). And as for in vitro, a positive result was observed in TA100 without metabolic activation in one bacterial reverse mutation test, but all the other reverse mutation tests were negative. Furthermore, it was also negative in a chromosomal aberration test with cultured mammalian cells. Negative and positive results were seen in mouse lymphoma tests with cultured mammalian cells, but it is concluded in EU-RAR (2004), EHC 189 (1997), SIDS (2001), CaPSAR (1994) that this substance is not mutagenic. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
6 | Carcinogenicity | Classification not possible |
- |
- | - | In preparation. Check the Japanese version. | FY2022 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1)) |
7 | Reproductive toxicity | Category 1B |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
From descriptions in the Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), in oral dose (feeding) reproductive toxicity tests with rats and mice, reduced fertility of F0, atrophy of the testis, decreased sperm production ability, miscarriage in the second trimester of pregnancy, and decreased numbers of pups born (rate) were observed. And in multiple developmental toxicity tests in which pregnant rats and mice were orally administered (gavage or feeding), fetuses and offspring showed malformations (external malformations, skeletal malformations), furthermore in rats, abnormal development of the testis and accessory reproductive glands was found in males of the next generation. Most of the reproductive toxicity in rats and developmental toxicity effects in rats and mice occurred from the doses where general toxicity effects such as reduced weight gain and increased liver weights were not seen in parent animals. Therefore, it was classified in Category 1B according to the GHS classification guidance for the Japanese government. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
8 | Specific target organ toxicity - Single exposure | Category 3 (Respiratory tract irritation) |
Warning |
H335 | P304+P340 P403+P233 P261 P271 P312 P405 P501 |
It was classified in Category 3 (respiratory tract irritation) because irritation of the upper respiratory tract, respiratory depression symptoms, etc. were observed at 250 mg/m3 (converted guidance value: 0.125 mg/L/4 hours) in an inhalation exposure (aerosol) test with mice (ACGIH (7th, 2001)). Besides, Category 1 (kidney) was also adopted in the previous classification, but effects on the kidney in humans are limited to a case report on one person. The effects on the nervous system in humans cannot be attributed to this substance (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). As described in the above, it was judged that there were no data on human effects available for classification. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs) |
Danger |
H372 | P260 P264 P270 P314 P501 |
It is described that in a 4-week inhalation (aerosol) exposure test with rats, hyperplasia of mucous cells of the nasal cavity and squamoid metaplasia of the larynx were observed as local effects from the low concentration (118 mg/m3: converted guidance value concentration: 0.00036 mg/L/6 hours) within the guidance value range for Category 1 (EU-RAR (2004)). Therefore, it was classified in Category 1 (respiratory system). As for oral administration, in all tests with mice or rats, adverse effects on the liver, blood, testis, etc. were found at higher doses (238 mg/kg/day or above) above the guidance values for Category 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). Therefore, it was classified in Category 1 (respiratory system). Besides, there are no reliable reports on effects in humans. Furthermore, as for Category 2 (liver) in the previous classification, the liver was removed this time because the rationale was not shown in the previous classification, and it was confirmed that the liver was not included in the target organ. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2013 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | Category 1 |
Warning |
H400 | P273 P391 P501 |
In preparation. Check the Japanese version. | FY2022 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1)) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Category 2 |
- |
H411 | P273 P391 P501 |
In preparation. Check the Japanese version. | FY2022 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1)) |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | In preparation. Check the Japanese version. | FY2022 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1)) |
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