GHS Classification Result

Chemical Name：Dicyclohexan-1-yl phthalate
CAS：84-61-7

Result：
ID: 2-078
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 - - - - Even if it contacts the normal temperature air, it does not ignite spontaneously (ignition temperature 395degC (Merck KGaA data from March 2009)).
11 Self-heating substances and mixtures Classification not possible - - - - The test method applicable for substances becoming liquid or gas at 140degC of test temperature has not been established.
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） Not classified - - - - It was classified into "Not classified" from LD50 value >3,200 mg/kg (NICNAS (2008), CERI/NITE Hazard Assessment Report (2008)), and >40,000 mg/kg (the 3rd volume (2004) of MOE risk assessment) of the oral administration test employing a rat.
1 Acute toxicity （Dermal） Classification not possible - - - - Although NICNAS (2008) and CERI/NITE Hazard Assessment Report (2008) has described LD50 value >300 mg/kg of the dermal administration test employing a rabbits, since the category cannot be identified, classification is not possible.
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 - - - - It is written that LC50 value of 1-hour inhalation exposure test employing rats is >3.2 mg/L (CERI/NITE Hazard Assessment Report (2008)). Since 4-hour equivalent LC50 value is >0.8 mg/L when applying the dust standard due to a solid, the classification cannot be specified, and classification is not possible.
2 Skin corrosion/irritation Not classified - - - - Since there are descriptions, "not irritating" in the skin irritation/corrosion test with rabbits (OECD TG 404) and "slightly irritating" in the study with guinea pig (CERI/NITE Hazard Assessment Report (2008)), it was classified into "Not classified".
3 Serious eye damage/eye irritation Not classified - - - - Since CERI/NITE Hazard Assessment Report (2008) has described as "not irritating" in eye irritation/corrosion test employing rabbits (OECD TG 405), it was classified into "Not classified ".
4 Respiratory sensitization Classification not possible - - - - Classification is not possible because of insufficient data. In addition, for the impact to humans, the report suggesting asthma was seen in HSDB (2002).
4 Skin sensitization Classification not possible - - - - Although there is a description of no sensitization in the test employing guinea pig (CERI/NITE Hazard Assessment Report (2008), IUCLID (2000)), classification is not possible because of insufficient data.
5 Germ cell mutagenicity Classification not possible - - - - Although there is a data that in vitro mutagenicity test (Ames test employing Salmonella typhimurium) is negative in NTP DB (Access on October 2008), classification is not possible because there is no data of in vivo examination.
6 Carcinogenicity Classification not possible - - - - Classification is not possible due to insufficiency of data, because evaluation by major international evaluation institutions has not been performed.
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 ... 		In a study with female rats which were administered orally from day 0 of gestation until day 21 of rearing, it is reported that "at doses at which lower body weights, increases in liver and adrenal gland weights and centrilobular swelling of hepatocytes were observed in parent animals, prolonged gestation periods and a decrease in the number of births were observed. The following effects on offspring were also observed at the same doses: lower body weight and defects in the kidneys and ureter in males and females; lower kidney, testis, seminal vesicle, epididymis, prostate and anus-bulbocavernosus muscle weights, defects in seminal vesicles, epididymal hypoplasia/agenesis, small testes, loss of germ cells in testes, Leydig cell hyperplasia and loss of sperm in ducts of the epididymis in males; uterine hypoplasia/agenesis, ovarian and oviductal agenesis and mineral deposition at the kidney-corticomedullary junction in females" (CERI/NITE Hazard Assessment Report (2008)). Therefore, because effects were observed in the second generation at doses at which minor effects are observed in parent animals, it was classified as Category 1B. Also, in a two-generation reproductive toxicity study in male and female rats, it is reported that "in F0 and F1 male and female parent animals in the groups with 1,200 ppm or greater, decreased weight gain and feed intake and diffuse hypertrophy of hepatocytes and thyroid follicular epithelial cells were observed, and as effects on offspring, decreases in anogenital distances (AGD) and development of areola mammae were observed in the F1male offspring in the 6,000 ppm group and in the F2 male offspring in the groups with 1,200 ppm or greater" and "a decrease in the number of sperm, but no changes in mating fertility and fertility were observed in the F1 male parent animals" (CERI/NITE Hazard Assessment Report (2008), MOE Risk Assessment, vol. 3 (2004).
8 Specific target organ toxicity - Single exposure Category 3 （Respiratory tract irritation） Warning H335: May cause respiratory irritation (respiratory tract irritation) P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Since MOE Risk Assessment, Volume 3 (2004) has a description of "The eye, skin, and respiratory tract are irritated, it was classified into Category 3 (Respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In the two-generation reproduction toxicity study of dietary administration in male and female rats, "diffuse hypertrophy of hepatocytes in liver and follicular epithelial cell hypertrophy of the thyroid were observed in parent animals (F0)" (CERI/NITE Hazard Assessment Report (2008), MOE Risk Assessment vol 3 (2004)), and the primary document (Ministry of Economy, Trade and Industry (2003) Report on two-generation reproduction toxicity study of Dicyclohexyl phthalate) shows that "changes in the liver are considered to be caused by adaptive response induced by drug-metabolizing enzyme. And follicular epithelial cell hypertrophy of the thyroid is considered to be caused by the changes associated with hypertrophy of hepatocytes." Moreover, in the 90-day oral administration test, although it is not within the limits of the guidance value of Category 2, "histological changes in the liver and kidney were observed" (CERI/NITE Hazard Assessment Report (2008), MOE Risk Assessment vol 3 (2004)). Therefore, since some effects of the substance to liver are observed but considered to be caused by adaptive response, classification is not possible.
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） Not classified - - - - Since 72 hours ErC50 of the algae (Pseudokirchneriella subcapitata) and, 48 hours EC50 of the crustacea (Daphnia magna) and 96 hours LC50 the fish (Oryzias Latipes) were >2.0mg/L (MOE eco-toxicity tests of chemicals (1999)) and acute toxicity within the aqueous solubility concentrations is not reported, it was classified into Not classified.
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Although acute toxicity within the water-solubility concentrations is not reported and it was poorly water-soluble (water solubility: 0.2mg/L(20degC) and 4mg/L(24degC) (PHYSPROP Database (2008), MOE Risk Assessment (2008))), since there were rapid degradability (readily degradable, the decomposition by BOD(standard test method (4 weeks)): 68.5% (Existing Chemical Safety Inspections Data (1977))), it was classified into Not classified.


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

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Model SDS by MHLW

 MHLW Website （in Japanese Only）

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