GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 123-30-8 |
| Chemical Name | p-Aminophenol |
| Substance ID | H28-B-07-METI, M-006B |
| Classification year (FY) | FY2016 |
| Ministry who conducted the classification | Ministry of Economy, Trade and Industry (METI)/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) | MHLW Website (in Japanese Only) |
| 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 |
- |
- | - | No data available. Besides, there is the information that it is combstible (HSDB (Access on October 2016)). |
| 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 |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 250 deg C (GESTIS (Access on October 2016)). |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No data available. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | 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). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. |
| 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) | Category 4 |
 Warning |
H302 |
P301+P312
P264 P270 P330 P501 |
Based on the LD50 value of 671 mg/kg (SIDS (2010)) for rats, this substance was classified in Category 4. The data in RTECS (2006) which was used for the previous classification was not adopted because the details of the data are unknown. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - |
Based on the LD50 value of >5,000 mg/kg (SIDS (2010)) for rats, it was classified as "Not classified." Although the test is evaluated as Reliability 4 (reliability not assignable) in SIDS (2010), the test data was adopted based on expert judgment because the test is adopted in SIAR (2010). Besides, the data in IUCLID (2000), RTECS (2006) which was used for the previous classification was not adopted because the details of the data are unknown. |
| 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) | Category 4 |
Warning |
H332 |
P304+P340
P261 P271 P312 |
A 1.3-hour LC50 value of > 5.91 mg/L (converted 4-hour equivalent value: > 1.92 mg/L) for rats (SIDS (2010)) was reported, and this corresponds in range of Category 4 to "Not classified." By adopting the category with higher hazard, this substance was classified in Category 4. Although the test is evaluated as Reliability 4 (reliability not assignable) in SIDS (2010), the test data was adopted based on expert judgment because the test was adopted in SIAR (2010). Besides, the data in IUCLID (2000) which was used for the previous classification was not adopted because the details of the data are unknown. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | It is reported that in a skin irritation test using rabbits, this substance was not irritating after 4-hour occlusive application of the substance (SIDS (2010)). Therefore, this substance was classified as "Not classified." The information used for the previous classification was not adopted for this classification because it is in List 3 or not available. The category was changed due to updated information. |
| 3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | It was reported that in an eye irritation test (OECD TG 405) using rabbits, slightly irritation was observed, and the AOI (acute ocular irritation index) was 9.33 (SIDS (2010)). On the basis of the AOI, it was classified as "Not classified." The information used for the previous classification was not used for this classification because it is in List 3 or not available. The category was changed due to updated information. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Because the information used for the previous classification does not describe a specific case, it was judged to be not enough to be used for classification. Therefore, the classification was changed. |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
In a sensitization test (patch test) using guinea pigs, the skin sensitization by this substance was reported (SIDS (2010)). Also in humans, a positive response in a patch test was observed in the multiple cases (SIDS (2010)). In SIDS (2010), the substance was evaluated as a sensitizing substance. From the above, this substance was classified in Category 1. |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 |
P308+P313
P201 P202 P280 P405 P501 |
As for in vivo tests, a negative result in a rat dominant lethal test, and a positive result in a micronucleus test using mouse bone marrow cells were reported (SIDS (2010), JECDB (Access on October 2016)). As for in vitro tests, a bacterial reverse mutation test was negative, and in cultured mammalian cell systems, a mouse lymphoma test was positive, a gene mutation test was negative, and a chromosomal aberration test and sister chromatid exchange test were positive (SIDS (2010), JECDB (Access on October 2016), NTP DB (Access on October 2016)). From the above, this substance was classified in Category 2, in accordance with the GHS Classification Guidance for the Japanese Government. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 7 | Reproductive toxicity | Category 2 |
Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
In a reproduction/developmental toxicity screening test (OECD TG 421; GLP) in which rats were orally dosed (gavage administration), at the high dose level (500 mg/kg/day) at which 4/12 males and 2/12 females died, decrease in spermatocytes and spermatid levels, vacuolation of the Sertoli cells in the testis, decrease in sperm counts and debris of germ cells in the epididymis lumen were observed in male parent animals. Disturbance of the sex cycle prolonged gestation period, and decreased delivery index were also observed in female parent animals; and in the offspring, decreased survival rate (postnatal day 4) and lowered pup weight (postnatal day 0 and 4) were observed (SIDS (2010), (JECDB (Access on October 2016)). As the above, the effects on genetic organs/sexual function of parent animals and reduced survival rate of the offspring were observed, but these findings were at the dose where parents died at a high rate (male 33%, female 17%), therefore, the test result was considered not appropriate for the classification. On the other hand, in a test in which female rats were dosed by feeding for 13 weeks followed by mating with untreated males, and administrated similarly until day 20 of gestation, above the dose where a decrease in weight gain was observed in maternal animals, increase of resorptions, ossification delay of sternebrae, skeletal variations (surplus ribs) were the only observation (SIDS (2010), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). Additionally, it is reported that in a test in which pregnant rats were dosed by gavage on day 11 of gestation that abnormality of the tail and paralysis of the hind limbs were observed (SIDS (2010), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). As the above, effects on reproduction and development were observed at dose where parental animals died at a high rate in the reproduction/developmental toxicity screening test using rats. However, in other test, it is reported that abnormity of the tail and paralysis of the hind limbs were observed in pups at doses where maternal toxicity in pregnant rats was manifested. From the above, the proper classification of this substance is judged to be Category 2. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. Though there is a description that this substance causes methemoglobinemia in humans (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), HSDB (Access on October 2016)), the details cannot be confirmed. The information on PATTY (4th, 1999) as the rationale for the previous classification for the occurrence of methemoglobinemia in humans is considered inadequate for the evidence of the effect on humans because the original references are a literature about an intraperitoneal administration experiment using mice and the Merck Index and because the information is not described in the fifth and sixth editions of PATTY. As for experimental animals, it is reported that in a single oral administration test in rats, the LD50 value is 671 mg/kg and lethargy and piloerection are observed as symptoms (SIDS (2010)). However, the target organs cannot be specified only by these pieces of information. Although there is a report that in a single intraperitoneal administration test in mice this substance generates methemoglobin in blood (Smith et al. : Biochemical Pharmacology, vol. 16, pp. 317 (1967)), this is not adopted as the rationale for classification because it was a test by intraperitoneal administration and the information source is not listed on the information source lists on the GHS classification guidance for the Japanese government. From the above, this substance is classified as "Classification not possible." The classification was changed upon review of the information sources for the previous classification and consideration of new materials. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (kidney) |
Warning |
H373 |
P260
P314 P501 |
In PATTY (6th, 2012), this substance was described as a renal toxic substance. As for experimental animals, in a 28-day gavage administration test using rats, brown urine, increase in epithelial cells in the urinary sediment, increase in kidney weight, and basophilic renal tubules are found at not less than 100 mg/kg/day (converted guidance value: 31 mg/kg/day) corresponding to Category 2. Death (1/12), white streaks in the cortico-medullary junction of the kidney, coagulative necrosis of tubular epithelium, decrease in the number of erythrocytes and hemoglobin density, increase reticulocyte count, increase in extramedullary hematopoiesis and hemosiderin deposit in the spleen are reported at 500 mg/kg/day (converted guidance value: 156 mg/kg/day), which exceeds Category 2 (JECDB (Access on October 2016), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), SIDS (2010)). Furthermore, it is reported that in a 6-month repeated dose toxicity test using rats dosed on the diet, nephrosis was observed at or above the lowest dose level of 0.07% (35 mg/kg/day), which corresponds to Category 2. A significant decrease in body weight gain and significant decreases in the red blood cell count and hemoglobin concentration were observed at the 0.7% (350 mg/kg/day), which is above Category 2. However, there were no significant changes in the methemoglobin concentration (Environmental Risk Assessment for Chemical Substances vol.5 (Ministry of the Environment, 2006)). From the above, the kidney was affected at the doses within the range of Category 2, and as for hematological system, the influence was observed at doses exceeding Category 2. In the previous classification, the description in PATTY (4th, 1999) that the substance causes renal toxicity and methemoglobinemia, was used for the rationale for taking the haemal system as the target organ in addition to the kidneys. In PATTY (6th, 2012), renal toxicity is described, but the effects on the haemal system were not described. Therefore, it is classified in Category 2 (kidney). |
| 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 48-hour EC50 = 0.098 mg/L for crustacea (Daphnia magna) (SIDS, 2010), it was classified in Category 1. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 |
P273
P391 P501 |
Because it is not rapidly degradable (a degradation rate by BOD: 6 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1997)), and its 72-hour NOEC = 0.025 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996)), it was classified in Category 1. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |