GHS Classification Result (Revision of the past classification result)

Chemical Name:Resorcinol
CAS:108-46-3

Result:
ID: 21B3062
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
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.
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 - - - - Auto-ignition point is 585 degC (Hommel (1996)) exceeding 70 degC.
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140 degC) substances are not 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 contains oxygen (but not fluorine or chlorine) in the molecule which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - 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.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
LD50 values are 980 mg/kg, 202 mg/kg, 301 mg/kg and 370 mg/kg for rats (CICAD 71 (2006)). Since three values correspond to Category 4 and the substance was classified into Category 4.
1 Acute toxicity (Dermal) Not classified - - - - Based on LD50 values of 3360 mg/kg (NTP TR403 (1992)), 3830 mg/kg (DFGOT vol. 20 (2003)) and 2830 mg/kg (CICADs No. 71 (2006)) for rabbits, the substance was classified as "Not classified" in JIS Classification (correspond to Category 5 in GHS classification).
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) Not classified - - - - Based on a LC50 (1h) value of 21.3 - 78 mg/L (4-hour equivalence: 5.3 - 19.5 mg/L) for rats (IUCLID (2000)), the substance was classified as "Not classified" in JIS Classification (correspond to Category 5 in GHS classification). (Since LC50 value (5.3 - 19.5 mg/L) was above the saturated vapour pressure concentration (0.029 mg/L) and the melting point was 110 degC, the test was considered to be conducted for dusts.)
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P362: Take off contaminated clothing and wash before reuse.
In two tests where application of 500 mg the substance mixed with water to the skin of rabbits for 24-hour (DFGOT vol. 20 (2003), CICADs No. 71 (2006)), slight to moderate irritation was caused (the primary irritation index was 2.8 and 4.4, respectively). Dermal exposure of humans was reported to cause dermatitis, hyperemia, and pruritis (PATTY (5th, 2001)). In a test of 268 workers in a motorcycle tire manufacturing plant, the presence of dermatitis was directly correlated with exposure to the processes involving the substance (NTP TR403 (1992)). Based on the animal and human data, the substance was classified into Category 2.
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
Based on a report that application into the eyes of rabbits caused irreversible corneal ulcerations (ACGIH (7th, 2001)) and a result of "extremely irritating" (irritation score was 105/110) in another test (CICADs No. 71 (2006)), the substance was classified into Category 1.
4 Respiratory sensitization Classification not possible - - - - Classification not possible due to lack of data. Of 600 workers who were repeatedly exposed in the rubber tire industry, 210 developed inflammatory disorders of the airways after the introduction of a new resorcinol-containing resin (DFGOT vol. 20 (2003)). The authors suggested that the cause could be delayed hypersensitivity reactions to volatile components or condensation products in the resin. The chemical responsible for the reactions was, however, not identified; therefore this test cannot be used in the present assessment (DFGOT vol. 20 (2003)).
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
Positive results (positive ratio: 30% (3/10) to 70% (7/10)) were reported in a guinea pig maximization tests. For humans, several patients developed clear vesiculobullous skin reactions after use of a preparation containing the substance to treat verruca plantar. The substance also produced marked to severe reactions in patch tests. The authors concluded from their tests that high concentrations of resorcinol should not be used in formulations for topical use because of the risk of sensitization (DFGOT vol. 20 (2003)). There is a report that 42 out of 268 workers from a tire factory showed clinical signs of dermatitis after predominantly dermal contact with the substance (CICADs vol. 71 (2006)). Based on the data obtained from an animal test and human case reports, the substance was classified into Category 1.
5 Germ cell mutagenicity Not classified - - - - Based on negative results in a bone marrow micronucleus test by oral administration to rats and a bone marrow micronucleus test by intraperitoneal administration to mice (in vivo somatic cell mutagenicity tests) (NTP TR403 (1992)), the substance was classified as "Not classified". As relevant information, there is a report of a negative rat bone marrow sister chromatid exchange test (in vivo somatic cell genotoxicity test). From in vitro mutagenicity tests, there are reports of a negative Ames test and positive chromosomal aberration tests using Chinese hamster ovarian cells and lung fibroblast cells, mouse lymphoma cells and human lymphocytes (NTP TR403 (1992)).
6 Carcinogenicity Not classified - - - - Based on the classifications of "Group 3" in IARC (IARC vol. 71 (1999)) and "A4" in ACGIH (ACGIH (2001)), the substance was classified as "Not classified". In 2-year oral tests in rats and mice (NTP TR403 (1992)), there were no increases in tumor incidence and no evidence of carcinogenicity in either species.
7 Reproductive toxicity Not classified - - - - In a two-generation reproductive toxicity test in rats with oral administration (CICADs (2006)), decreased mean cumulative body weight gains during the entire generation was observed in the high dose group but the sexual function and reproductive performance (mating, fertility, gestation) were unaffected. In rat and rabbit developmental tests by oral administration during the organogenesis period (DFGOT vol. 20 (2003)) (CICADs (2006)), maternal toxicity (body weight loss) was observed in some tests but there was no evidence of fetal toxicity or teratogenicity. Based on the data, the substance was classified as "Not classified" since there were no adverse effects on parental sexual function and fertility and fetal development.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, blood) Danger H370: Causes damage to organs (central nervous system, blood) P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
There are a number of case reports describing unconsciousness, tremors, convulsion, mydriasis, confusion, amnesia, disorientation and sometimes death following application of ointment or cream formulations containing the substance for treatment purpose (DFGOT vol. 20 (2003), PATTY (5th, 2001)). A child, after accidentally swallowing the substance, complained of dizziness, somnolence and tremors (PATTY (5th, 2001)). In persons suffering from resorcinol poisoning, the symptoms included CNS effects (ACGIH (7th, 2001), DFGOT vol. 20 (2003)). Based on the data, the substance was classified into Category 1 (central nervous system). In some of the case reports reported above, hemoglobinuria, cyanosis and methemoglobinemia were also reported mainly in infant cases (DFGOT vol. 20 (2003), PATTY (5th, 2001)), therefore, the substance was classified into Category 1 (blood system). Effects in the respiratory and cardiovascular systems were not reported. Findings of dyspnea, tachycardia and decreased blood pressure, which were used for the former classification, were attributed to cyanosis due to methemoglobinemia. For rats, signs of intoxication after oral administration included shivering, twitching and tonic-clonic seizures (CICADs 71 (2006)).
9 Specific target organ toxicity - Repeated exposure Category 1 (thyroid) Danger H372: Cause damage to organs through prolonged or repeated exposure (thyroid) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
There are a number of case reports describing hypertrophy of the thyroid or hypothyroidism following long-term application of formulations containing the substance for the purpose of skin disease treatment (CICADs 71 (2006), DFGOT vol. 20 (2003)). In an epidemiological test, goiter and hypothyroidism were suggested following occupational exposure (CICADs 71 (2006)). In animals, hypertrophy, hyperplasia and tumor development in the thyroid were indicated following oral, inhalation and dermal application in rats (CICADs 71 (2006), DFGOT vol. 20 (2003)). Based on the data, the substance was classified into Category 1 (thyroid gland).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 2 from its 48h-EC50 = 1.28 mg/L for Crustacea (Daphnia magna) (SIDS, 2009).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified into Not classified since it is rapidly degradable (BOD degradation rate: 66.7% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1976)) and low bioaccumulative potential is estimated (log Kow = 0.8 (PHYSPROP Database, 2009)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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