GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 123-31-9
Chemical Name Hydroquinone
Substance ID 24B6513
Classification year (FY) FY2012
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 FY2007   FY2006  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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

PHYSICAL HAZARDS
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
-
-
- - It is combustible (ICSC (J) (2001)), but the classification is not possible due to no data in the prescribed test.
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 516 deg C (NFPA (14th, 2010)).
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.
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
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
Seven LD50 values for rats [390 mg/kg, 302 mg/kg, 323 mg/kg, 298 mg/kg (the above four, SIDS (Access on Apr. 2012)), 320 mg/kg, 743 mg/kg, 627 mg/kg (the above three, EHC 157 (1994))] are reported, six correspond to Category 4, and one corresponds to 3. Therefore, it was classified in Category 4, to which most correspond. Besides, test data on non-fasted animals were not adopted because fasted animals were normally used in the test.
1 Acute toxicity (Dermal) Not classified
-
-
- - In 14-day repeated dermal administration tests with rats and mice, no deaths were observed in either animal species at the highest dose (rats 3,840 mg/kg/day, mice 4,800 mg/kg/day) (SIDS (Access on Apr. 2012)), and one dose exceeded the guidance value range. Therefore, it was classified as "Not classified" in the Classification JIS.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - No data available.
2 Skin corrosion/irritation Not classified
-
-
- - It is reported that in a test in which a 10% aqueous solution was applied to guinea pigs, there was slight irritation (EHC 157 (1994)), slight to moderate edema and moderate erythema were observed 24 hours after application of 0.25-1.0 g/kg to guinea pigs, but there were no skin reactions after that (SIDS (Access on Apr. 2012)), and an occlusive application test with rabbits resulted in the mean irritation score of 1.22 (1-4) and no irritation (IUCLID (2001)). Based on the above results, it was classified as "Not classified" in the Classification JIS (corresponding to Category 3 in UN GHS classification). Besides, in humans, it is described that use of 5% preparations of this substance for bleaching the skin is often accompanied by dermatosis, erythema, and burning (DFGMAK-Doc. 10 (1998)), and it is reported that in cases using 2% bleaching creams, there were four cases of leukoderma, which was not inflammatory, and a patch test in a 1% cream did not give a positive result after 72 hours (Initial Risk Assessment Report 114 (NITE, CERI, NEDO, 2008)).
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
It was classified in Category 1 because it is reported that the application of 100 mg to the conjunctival sac of rabbits led to corrosive damage (DFGMAK-Doc. 10 (1998)). Besides, it is reported that in a test in which crystalline powder of this substance was applied to the rabbit eye, erythema of the eyelid and nictitating membrane occurred, and erythema of the eyelid, orbit, and nictitating membrane persisted by 48 hours after application but was not observed after 14 days (SIDS (Access on Apr. 2012)). On the other hand, in humans, it is reported that there are cases of workers who developed eye irritation, damage to the corneal epithelium, etc., and corneal ulcer due to exposure to the dust of this substance and workers who had corneal and conjunctival pigmentation, corneal opacity, loss of vision, and astigmatism after long term exposure (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)).
4 Respiratory sensitization Classification not possible
-
-
- - No data available.
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
It was classified in Category 1 because it was assessed as a strong sensitizer by showing a positive rate of 70% (7/10) in a maximization test with guinea pigs (OECD TG 406) (EHC 157 (1994)). Besides, other maximization tests with guinea pigs were conducted and resulted in a positive rate of 50% (5/10) (EHC 157 (1994)) or a strong sensitizer (EHC 157 (1994)). Furthermore, this substance is listed as a contact allergen in Contact Dermatitis (5th, 2011).
5 Germ cell mutagenicity Category 1B


Danger
H340 P308+P313
P201
P202
P280
P405
P501
It was classified in Category 1B based on a positive result in a chromosomal aberration test with spermatocytes after intraperitoneal administration to mice (in vivo germ cell mutagenicity test) (EHC 157 (1994)) despite a negative result in a dominant lethal test by oral administration to rats (in vivo heritable germ cell mutagenicity test) (EHC 157 (1994)). And there are reports on positive results in a chromosomal aberration test with bone marrow cells after intraperitoneal administration to mice and a micronucleus test with bone marrow cells after oral administration to mice (Initial Risk Assessment Report 114 (NITE, CERI, NEDO, 2008)), and a positive result in a spot test by intraperitoneal administration to mice (EHC 157 (1994)) (all, in vivo somatic cell mutagenicity test). Besides, as for in vitro tests, an Ames test was negative (NTP DB (1979)), but it is reported that a micronucleus test with V79 cells was positive (IARC 71 (1991)), and a micronucleus test with human lymphocytes gave a positive result (IARC 71 (1999)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
As for carcinogenicity assessment, ACGIH classified it in A3 (ACGIH (2008)), corresponding to Category 2, and IARC classified it in Group 3 (IARC 71 (1999)), corresponding to "Classification not possible." The category is different between the two, but it was classified in Category 2 by adopting the ACGIH's assessment, which was newer. Besides, in 2-year oral administration carcinogenicity tests with rats and mice, it is reported that there was some evidence of carcinogenicity for male and female rats based on marked increases in tubular cell adenomas of the kidney in males and increases in mononuclear cell leukemia in females (NTP TR 366 (1989)). On the other hand, as for mice, it is reported that there was no evidence of carcinogenicity for males and some evidence of carcinogenicity for females based on increases in hepatocellular neoplasms, mainly adenomas (NTP TR 366 (1989)). It was classified as Cat. 3; R40 in EU classification (EC-JRC (ESIS) (Access on Apr. 2012)).
7 Reproductive toxicity Not classified
-
-
- - In a two-generation reproductive test by oral administration to rats (OECD TG 416), parent animals showed tremor and reduced weight gain at or above 50 mg/kg/day, but there were no abnormalities in fertility such as male and female fertility index, and no anomalies were observed in the number of live pups, sex ratio, body weight until weaning, etc. in offspring (Initial Risk Assessment Report 114 (NITE, CERI, NEDO, 2008)). On the other hand, in tests by oral administration to pregnant rats and rabbits during the organogenesis period (OECD TG 414), in rats, maternal animals in the 300 mg/kg/day group showed reduced weight gain during treatment, but there were no abnormalities in numbers of corpus luteum verum, implantations, resorptions, and live fetuses, and fetal sex ratio and so on, and no external, visceral, or skeletal malformations were observed in fetuses at the same dose (Initial Risk Assessment Report 114 (NITE, CERI, NEDO, 2008)). Also, in rabbits, maternal animals showed reduced body weight gain at 150 mg/kg/day, but the examination of fetuses revealed no statistically significant changes in the incidences of external, visceral, or skeletal malformations at 150 mg/kg/day (Initial Risk Assessment Report 114 (NITE, CERI, NEDO, 2008)). Because no adverse effects on sexual function/fertility or development of offspring were found in the two-generation reproductive test and the developmental toxicity tests above, it was classified as "Not classified."
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501
The main symptoms of intoxication reported in humans were neurological ones, including tremors, convulsions, loss of reflexes, and coma (EHC 157 (1994), DFGMAK-Doc. 10 (1998)). On the other hand, in an acute oral toxicity test with rats (LD50 value: 627-743 mg/kg), death occurred during a tonic spasm (EHC 157 (1994)), and in an acute oral toxicity test with dogs (LD50 value: 200 mg/kg), hyperexcitability, tremors, convulsions, incoordination of the hindlimbs, etc. are reported (EHC 157 (1994)). As above, in addition to neurological symptoms due to exposure in humans, signs showing effects on the central nervous system were found in animal tests, especially in dogs, the symptoms occurred at the dose corresponding to the guidance values for Category 1. Therefore, it was classified in Category 1 (central nervous system). Besides, single oral administration to F344 rats caused nephrotoxic effects, but because there is the knowledge that no nephrotoxic effects were observed in SD rats or B6C3F1 mice (DFGMAK-Doc. 10 (1998)), kidney lesions in rats were not used for the rationale for classification.
9 Specific target organ toxicity - Repeated exposure Category 2 (kidney, liver)


Warning
H373 P260
P314
P501
In a 15-month oral administration test with rats, increased severity of nephropathy was seen only in males at or above 25 mg/kg/day (NTP TR 366 (1989)), and in a 13-week oral administration test with rats, toxic nephropathy characterized by tubular cell degeneration in the renal cortex was observed in males at 200 mg/kg/day and females at or above 100 mg/kg/day (NTP TR 366 (1989)). From the above, because 25 and 100 mg/kg/day corresponds to the guidance values for Category 2, it was classified in Category 2 (kidney). And in 15-month or 2-year oral administration tests with mice, increased incidences of anisokaryosis, syncytial alteration, and basophilic foci were found in the liver at 100 mg/kg/day, which corresponds to guidance values for Category 2 (NTP TR 366 (1989)). Therefore, it was classified in Category 2 (liver).
10 Aspiration hazard Classification not possible
-
-
- - No data available.

ENVIRONMENTAL HAZARDS
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
It was classified in Category 1 from 96-hour LC50 = 0.044 mg/L for fish (Pimephales promelas) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)).
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 rapidly degradable (readily biodegradable (a 2-week degradation rate by BOD: 70%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1975)), 72-hour NOEC = 0.0015 mg/L for algae (Pseudokirchneriella subcapitata) (Environmental Risk Assessment for Chemical Substances Vol. 10 (Ministry of the Environment, 2012)), and 21-day NOEC = 0.003 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 10 (Ministry of the Environment, 2012)).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to being rapidly degradable (readily biodegradable (a 2-week degradation rate by BOD: 70%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1975)), and a low bioaccumulation estimate (log Kow = 0.59 (PHYSPROP Database, 2009)), despite 96-hour LC50 = 0.044 mg/L for fish (Pimephales promelas) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)).
By drawing a comparison between the above results, it was classified in Category 1.
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.

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