GHS Classification Result

Chemical Name：3,3-Bis(4-hydroxyphenyl)isobenzofuran-1(3H)-one
CAS：77-09-8

Result：
ID: 2-074
Classifier: Ministry of Economy, Trade and Industry （METI）, 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
3 Aerosols Not applicable - - - - Not aerosol products
4 Oxidizing gases Not applicable - - - - Solid
5 Gases under pressure Not applicable - - - - Solid
6 Flammable liquids Not applicable - - - - Solid
7 Flammable solids Classification not possible - - - - Classification not possible due to lack of data
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups associated with explosive or self-reactive properties present in the molecule.
9 Pyrophoric liquids Not applicable - - - - Solid
10 Pyrophoric solids Not classified - - - - It is stable in the air (HSDB,2004).
11 Self-heating substances and mixtures Classification not possible - - - - Classification not possible due to lack of data
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - Metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) are not included.
13 Oxidizing liquids Not applicable - - - - Solid
14 Oxidizing solids Not applicable - - - - Although it is an organic compound including oxygen, not fluorine and chlorine, this oxygen has not chemically bound to any elements other than carbon and hydrogen.
15 Organic peroxides Not applicable - - - - The organic compound not including peroxy group in 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） Classification not possible - - - - Although there is a description of oral lethal dose of rats with >1,000 mg/kg (RTECS (2007)), since the category cannot be specified, classification is not possible.
1 Acute toxicity （Dermal） Classification not possible - - - - Classification not possible due to lack of data
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Since it was a solid by the definition of GHS and inhalation in gas was not assumed, it was classified into "Not applicable".
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - Classification not possible due to lack of data
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - Classification not possible due to lack of data
2 Skin corrosion/irritation Classification not possible - - - - Classification not possible due to lack of data
3 Serious eye damage/eye irritation Classification not possible - - - - Classification not possible due to lack of data
4 Respiratory sensitization Classification not possible - - - - Classification is not possible since there is no data.
4 Skin sensitization Classification not possible - - - - As a human case, although it has been described that "an allergic symptom by Phenolphthalein, dermatitis reaction or fixed drug eruption, is characterized by repeated onset at the same place, leading to hyperpigmentation" (IARC 76 (2000)), classification is not possible because of inadequate data.
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		There are statements that the chromosome aberration test employing the mouse bone marrow from a body cell in vivo mutagenicity test was "negative", but the six micronucleus tests employing mouse erythrocyte was "positive" (NTP DB (Access on November 2008)). The sampling time of a chromosomal aberration test was after 17 hours, which is insufficient for evaluation. On the other hand, five out of six micronucleus tests were performed for six weeks to 26 weeks by mixed-feed-administration for several times, and all of the five cases' sampling time was after 28 hours. One case's result was derived from the single administration and the sampling time of after 48 hours. Rather than weight of evidence, the positive result of micronucleus test was adopted and it classified into Category 2.
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Since it is estimated group 2B (IARC 76 (2000)) by IARC and was estimated R (NTP RoC (11th, 2005)) by NTP, it was classified into Category 2.
7 Reproductive toxicity Category 1B Danger H360: May damage fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Since there are descriptions as follows in the mixed food administration study using mice, "The number of male and female groups giving birth to the 2nd to 5th children significantly decreased and the average number of children per litter also decreased by 24% at the concentration level of 1,000mg/kg or more. The number of sperms in the epididymis of F0 generation males considerably decreased resulting in degeneration of seminiferous tubules" (IARC 76 (2000), and "Effects on parent animals, both male and female, only caused slight reduction in food consumptions but there was no body weight decrease, "in this cited literature (Environ. Health Perspect. 105 (1997)), it was classified in Class 1B. There are, however, descriptions as follows, " It was prescribed for 236 pregnant wemen at an early stage and 806 pregnant women but teratogenicity was not identified in newborns" (HSDB (2004)) as human epidemiological data and "Teratogenicity was not observed " (HSDB (2994)) in the 3 generation study of mice.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - As for human cases, there is a description that "a woman who did unspecified quantity ingestion of the tablets including this article developed multiorgan failure, and died as a result of a coma, lung dropsy, a myocardial failure, an acute kidney tubular necrosis, and disseminated intravascular coagulation" (HSDB (2004)), however, classification is not possible since the effects in survivors is unknown.
9 Specific target organ toxicity - Repeated exposure Category 1 (intestine) Danger H372: Cause damage to organs through prolonged or repeated exposure (intestine) 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 ... 		As an impact on human, there are descriptions of "The symptoms of abdominal discomfort, diarrhea, and vomiting having been shown, and a blood pressure fell, and feeling of weariness had been seen in remedial oral administration." and of "Major target organ is an intestine and the clinical symptom is similar to the chronic ulcerative colitis."(IARC 76 (2000)). Although there was a description of "the weight reduction and the decreased weight gain were seen significantly in the female rat and the hypoplasia of bone marrow was seen in the male and female mice " (NTP TR465 (1996)) in the 13 weeks oral administration test employing rats and mice, since the effect on the bone marrow was seen out of the range of the guidance value of Category 2, it was classified into Category 1 (intestines).
10 Aspiration hazard Classification not possible - - - - Classification not possible due to lack of data

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Classification not possible - - - - No data available
11 Hazardous to the aquatic environment （Long-term） Classification not possible - - - - No data available


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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