GHS Classification Result

Chemical Name：4-Nonylphenol (branched)
CAS：84852-15-3

Result：
ID: 22A4030
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

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 molecule.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Liquid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Liquid (GHS definition)
5 Gases under pressure Not applicable - - - - Liquid (GHS definition)
6 Flammable liquids Not classified - - - - Its flash point reported 155 degC (closed-cup) (IUCLID (2000)) is >= 93 degC.
7 Flammable solids Not applicable - - - - Liquid (GHS definition)
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 classified - - - - Since its auto ignition point is about 370 degC (industrial substance mainly containing p-isomer) (Hommel (1996)), it is considered that the substance does not ignite at room temperature.
10 Pyrophoric solids Not applicable - - - - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to liquid 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 - - - - The substance is an organic compound containing oxygen which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - No data available. As relevant note, stainless steel is durable as a container (Hommel (1996)).

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 ... 		The one LD50 value for rats of 580 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment vol. 2 (2003)), which was the data from the "List 1" information source designated in the GHS classification guidance for the Japanese government was reported. And three LD50 values (1900 mg/kg, 1882 mg/kg and 1246 mg/kg) from studies which were complying with the test guidelines (OECD TG 401 or USA IRLG Guideline) (IUCLID (2000)), which was the "List 2" information designated in the same guidance mentioned above, were reported. All data were equivalent to Category 4, the substance was classified as Category 4.
1 Acute toxicity （Dermal） Not classified - - - - Based on the rabbit LD50 value of 2037 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment vol.2 (2003)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 in the UN-GHS classification). For further information, another rabbit LD50 values of > 2000 mg/kg (IUCLID (2000)) was documented.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Liquid (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 Category 1 Danger H314: Causes severe skin burns and eye damage P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN （or hair）: Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In the rabbit test (OECD TG 404), occlusive administration of 0.5 ml of test substance caused mild to moderate erythema, and mild to moderate edema at 3 minutes of exposure, moderate erythema and severe edema at 4 hours, subsequently, epidermal necrosis, full-thickness skin necrosis, fissure, exfoliation, ulceration, loss of hair, crust formation and cicatrization were observed. The substance was classified as Category 1 since the symptoms were not reversible (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)).
3 Serious eye damage/eye irritation Category 2 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. 		In the rabbit test, instillation of 0.1 ml or 100 mg of the substance caused moderate to severe irritation (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)). In another rabbit test (OECD TG405), irritation was caused and irritation score was 38.42/110 (IUCLID (2000)). Based on these documents, the substance was classified as Category 2. Pre-existing classification for skin corrosion/irritation is Category 1.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - In EU-RAR 10 (2002), three guinea pig maximization tests were reported. Two cases reported that the substance was non-sensitizing, and the other case was inconclusive because of the defect of test methods. In Initial Risk Assessment Report (Ver.1.0, No.1, NITE, CERI, NEDO) (2005), there were 5 reports in which the substance was concluded as non-sensitizing excepting the studies that have defects of test methods. Thus, there were no clear conclusion about sensitization in the information source, the substance was classified as "Classification not possible".
5 Germ cell mutagenicity Not classified - - - - The substance was classified as "Not classified" based on the negative results in the micronucleus test using the bone marrow cells of mice (in vivo mutagenicity test in somatic cells) in both administrations with intraperitoneal and oral (EU-RAR (2002)). As relevant information, as for in vitro studies, negative results in the Ames test and in the chromosome aberration test using CHL cells (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)) as well as the HPRT gene mutation test (OECD TG 476) using Chinese hamster V79 cells (EU-RAR (2002)) were reported.
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging 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 the two-generation reproductive toxicity study by oral administration in rats, effects of reproductive parameter such as decrease in the number of implantation and live pups were observed at the dose level (50 mg/kg/day) causing general toxicity (increases in weights of the liver and kidney) in parental animals (Initial Environment Risk Assessment of Chemicals (Ministry of Environment), vol. 2 (2003)). Therefore, the substance was classified as Category 2. As relevant information, in the three-generation reproductive toxicity study by oral administration using rats, there were no adverse effects on sexual functions and fertility of parents and developmental indices for litter were observed, however prolongation of the estrus cycle and accelerated vaginal opening in females, decreased testicular spermatid counts in males were reported (NTP TR (1997)).
8 Specific target organ toxicity - Single exposure Category 3 （Narcotic effects, Respiratory tract irritation） Warning H336: May cause drowsiness or dizziness (narcotic effects, respiratory tract irritation)
H335: May cause respiratory irritation (narcotic effects, 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 ... 		Based on the reports that the clinical signs after oral administration in rats included sedation, ataxia, and lethargy, etc. (Initial Risk Assessment Report (NITE, CERI, NEDO (2005)), EU-RAR (2002)), the substance was classified as Category 3 (narcotic effects). Additionally, from a description that in mice exposed to saturated vapor, irritating effects on the respiratory system were observed (EU-RAR (2002)), the substance was classified as Category 3 (irritation in the respiratory tract). Besides, it was also reported that inflammatory changes in the gastrointestinal tract (Initial Risk Assessment Report (NITE, CERI, NEDO (2005))) and an erosion of the mucosal surface of the stomach (EU-RAR (2002)) were observed in dead animals. But the information was not adopted as evidence to classify because these were considered as local effects by corrosive/irritating property of this substance.
9 Specific target organ toxicity - Repeated exposure Category 2 (liver, kidney) Warning H373: May cause damage to organs through prolonged or repeated exposure (liver, kidney) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		In the 28-day repeated dose oral toxicity study in rats, the findings noted at 250 mg/kg/day (converted dose level as that of 90-day study: 77.8 mg/kg/day) included centrilobular hypertrophy of hepatocytes, basophilic cytoplasm in renal proximal tubules, basophilic and dilated collecting tubule, transitional epithelial hyperplasia of the urinary bladder in both sexes. Furthermore, in the kidneys in females, scattered whitish points and enlargement, necrosis of epithelial cells in proximal tubules, inflammatory infiltration in interstitial cells, cast, hyperplasia in renal pelvic mucosa and dilatation of renal pelvis were observed (Initial Risk Assessment Report (NITE, CERI, NEDO (2005)). Moreover, in the 90-day feeding study with rats, it was reported that the only noteworthy histopathological changes were found in the liver and kidneys, and that slight to moderate hepatic cell necrosis accompanied by the marked elevation of hepatic enzymes (AST and ALT) were noted in some animals in 2000 ppm (140 mg/kg/day) group (EU-RAR (2002)). In the rat feeding study over three generations (3-generation reproductive toxicity study), degeneration or hypertrophy in renal tubules was noted in males of all generations and in females of third generation at the dose levels of 15 mg/kg/day or more, and in females of F1 and F2 generations at 160 mg/kg/day (Initial Environment Risk Assessment of Chemicals (Ministry of Environment), vol. 2 (2003)). According to the results described above, histopathological changes in the liver and kidneys were found at doses applicable to Category 2 of the guidance values or higher, thus the substance was classified as Category 2 (liver, kidney).
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 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 1 from its 96h-EC50 = 0.027 mg/L for algae (Skeletonema costatum) (EU-RAR, 2002).
11 Hazardous to the aquatic environment （Long-term） Category 1 Warning H410: Very toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 1 since its acute toxicity is Category 1 and it is not rapidly degradable (EU-RAR, 2002).
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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