GHS Classification Result

Chemical Name：bis-[4-(2,3-epoxipropoxi)phenyl]propane
CAS：1675-54-3

Result：
ID: 20A2063
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government （Sep, 2008）

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 solid Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Classification not possible - - - - The molecule contains chemical groups (epoxide) associated with self-reactive properties. Classification is not possible due to lack of data.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140degC) 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) 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 - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Not classified - - - - Since the rat LD50 = 22736mg/kg (IARC 47 (1999)), the substance was classified into "Not classified".
1 Acute toxicity （Dermal） Not classified - - - - Based on the rabbit LD50 of > 23200mg/kg (IARC 47 (1999)), the substance was classified into "Not classified".
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 - - - - The rabbit tests resulted in that the substance was not irritating (Hazard Assessment Report (CERI, NITE) (2006)). In addition, administration of the substance, 20% solution or undiluted, caused slight or no irritation (DFGOT vol.19 (2003)). Based on these results, the substance was classified into "Not classified". As relevant notes, in primary skin irritation tests following the Draize test procedure with occlusive application of the substance to the skin of rabbits for 24 hours, the substance was moderately irritating (Hazard Assessment Report (CERI, NITE) (2006)). In addition, some commercial products containing the substance may cause irritation.
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection. 		The tests, in which the substance was administrated into the eyes of rabbits, resulted in marked irritation (DFGOT vol.19 (2003)). In addition, the substance has been classified into R36 in the EU classification (EU-Annex1 (accessed July 2008)). Thus, the substance was classified into Category 2A.
4 Respiratory sensitization Classification not possible - - - - Two patients with allergic contact dermatitis and respiratory symptoms such as rhinitis and asthma tested positive by prick tests (DFGOT vol.19 (2003). In addition, cement workers, who repeatedly exhibited contact dermatitis by exposure to this substance, were suspected to have occupational asthma, which turned out to be mild bronchial hyperreactivity. However, there was not sufficient data to support that respiratory allergies were caused by this substance (DFGOT vol.19 (2003)). Since both cases were not concluded to be positive reactions due to the substance, classification is not possible.
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 ... 		Two kinds of skin sensitization tests using guinea pigs (maximization test and Buehler test) were conducted and both tests yielded positive results (DFGOT vol.19 (2003)). Furthermore, according to epidemiological studies, many people who were exposed to epoxy resin that contains this substance developed allergic contact dermatitis (CERI / NITE hazard assessment reports (2006), DFGOT vol.19 (2003)). Some of these studies concluded that this substance caused skin sensitization (CERI / NITE hazard assessment reports (2006)). In addition to these positive results documented, the substance has been categorized into R43 in the EU classification, and Sh in the DFG classification, both of which indicate it is skin sensitizing. Thus, the substance was classified into Category 1.
5 Germ cell mutagenicity Not classified - - - - The substance was classified into "Not classified" based on negative results obtained from the following tests: dominant lethal tests (heritable mutagenicity tests) using mice that underwent oral or dermal administration, chromosomal aberration tests using testicular germinal epithelium from mice that underwent oral administration (in vivo mutagenicity tests using somatic cells), micronucleus tests using the bone marrow cells from mice or Chinese hamsters that underwent oral administration, and chromosomal aberration tests using the bone marrow cells of Chinese hamsters that underwent oral administration (in vivo mutagenicity tests using somatic cells) (DFGOT vol.19 (2003)). Based on these results, the substance was classified into "Not classified". Among in vitro tests, positive results have been documented from reverse mutation tests using bacteria, mutation tests using mouse lymphoma cells, and chromosomal aberration tests (DFGOT vol.19 (2003)).
6 Carcinogenicity Not classified - - - - Since the substance has been classified by the IARC into Group 3 (IARC (vol.47 1999)), it was classified into "Not classified". Although several tests have been conducted in which rats or mice underwent dermal route exposure for 2 years, there was no difference in the frequencies of tumorigenesis between treated and control groups (DFGOT vol.19 (2003), IARC 47 (1999)).
7 Reproductive toxicity Not classified - - - - In reproductive tests using rats that underwent oral route exposure for one or two generations, decreased body weight gain of parental animals was indicated, but no effects of the substance were observed on reproductive functions, fertility, the development of offspring, and survival of offspring after birth (DFGOT vol.19 (2003)). Furthermore, in developmental toxicity tests using rats or rabbits that underwent oral route exposure during the organogenetic period, mild toxicity was detected in maternal animals at high administration doses, but no adverse effects on the development of offspring and teratogenicity were observed (DFGOT vol.19 (2003)). Since no adverse effects of the substance on reproductive functions and fertility have been detected in reproductive and developmental toxicity tests, the substance was classified into "Not classified".
8 Specific target organ toxicity - Single exposure Classification not possible - - - - Classification not possible due to lack of data.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In the oral administration tests using rats that were applied with the substance at 1000mg/kg/day for 28 days (90-day conversion: 311mg/kg/day) or at 1500mg/kg/day for 90 days, no toxic effects were observed other than reduced body weight (DFGOT vol.19 (2003)). Similarly, the tests in which rats underwent oral administration (diet containing the substance) for 26 weeks did not yield significant toxicological changes, and the NOAEL was determined to be 100mg/kg/day (Hazard Assessment Report (CERI, NITE) (2006)). In addition, in the dermal route exposure tests using mice that were applied with doses up to 1000mg/kg/day for 13 weeks, no changes in skin were observed other than localized effects (Hazard Assessment Report (CERI, NITE) (2006)). In the tests using rats, no toxic effects of the substance were detected other than suppressed amounts of food intake and decreased body weight gain (Hazard Assessment Report (CERI, NITE) (2006)). In the tests in which test animals were dermally exposed to the substance up to 1000mg/kg/day for 103 weeks, there were no significant changes observed compared with control groups other than effects due to skin irritation (Hazard Assessment Report (CERI, NITE) (2006)). From these results, no systemic toxicity was observed at the doses higher than the upper limit of Category 2 guidance values (100-1000mg/kg/day) in all of the oral and dermal administration tests using rats or mice with different exposure periods. Although these results indicated that the substance was to be classified into "Not classified" (oral and dermal routes), in conclusion, the substance was classified into "Classification not possible" due to lack of information on inhalation route exposure.
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 ... 		Since its 48-hour EC50 = 1.7mg/L for crustaceans (Daphnia magna) (Initial Risk Assessment Report (NITE, CERI, NEDO), 2008), the substance was classified into Category 2.
11 Hazardous to the aquatic environment （Long-term） Category 2 - H411: Toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Since its classification for acute toxicity is Category 2, and it is not rapidly degradable (non-biodegradable, BOD degradability: 0% (Initial Risk Assessment Report (NITE, CERI, NEDO), 2008)), the substance was classified into Category 2.


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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