GHS Classification Result

Chemical Name:beta-Phenylethyl alcohol; Phenethyl alcohol
CAS:60-12-8

Result:
ID: 22A4113
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 96 degC (closed-cup) (Lide (90th, 2009)) 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 autoignition temperature is 410 degC (IUCLID (2000)), 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 (but not fluorine or chlorine) 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.

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 ...
Six LD50 values for rats of 1800, 1500, 1800, 2500, 1700 mg/kg (above JECFA (2003)) and 2509 mg/kg (PATTY, 5th (2001)) were reported, and four of them were equivalent to Category 4. Thus, the substance was classified as Category 4.
1 Acute toxicity (Dermal) Category 3 Danger H311: Toxic in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment (see ... on this label).
P361: Remove/Take off immediately all contaminated clothing.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on the rabbit LD50 value of 805 mg/kg bw (PATTY, 5th (2001)), the substance was classified as Category 3.
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 - - - - The rat LC50 value of > 1.38 mg/L/4hrs was reported (IUCLID (2000)). Since the value did not provide a basis for classification, the substance was classified as "Classification not possible". According to the description of the "aerosol" exposure (IUCLID (2000)), the criterion values for mist/dust were adopted.
2 Skin corrosion/irritation Not classified - - - - In duplicate rabbit tests that 4-hour application of 0.5 ml of the test substance to the skin, the primary skin irritation index value (PII) were 2.22 and 0.92 (ECETOC TR66 (1995)). In human case report, 24-hour application of undiluted substance to 20 subjects caused no irritation (IUCLID (2000)). Based on these documents, the substance was classified as "Not classified".
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, application of 0.005 mL of undiluted substance or 0.05 mL of 5 - 15% of the substance in propylene glycol solution to the eye caused severe corneal irritation and iritis (PATTY, 5th (2001)). Based on these documents, the substance was classified as Category 2. As relevant notes, instillation to the human eye with 0.75% or 0.6% of aqueous solution caused irritation (PATTY, 5th (2001)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - Insufficient data were available. As for the results of the skin sensitization tests in guinea pig, positive results in the optimization test and negative results in the open epicutaneous test were reported (IUCLID (2000)). These were reciprocal results, and neither of the test methods were authorized by the OECD. As relevant notes, sensitization test on 25 test subjects, the substance was not sensitizing (PATTY, 5th (2001)). On the other hand, local reaction suggesting sensitization was reported in patients who have various types of skin disease (PATTY, 5th (2001)).
5 Germ cell mutagenicity Classification not possible - - - - The classification was not possible due to lack of in vivo test data. As relevant information, as for in vitro study, negative results in the Ames test were reported (JECFA (2003)).
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 oral administration study using pregnant rats during the organogenetic period, while no information on maternal toxicity was reported, dose-related increases in the incidence of malformations were reported, the malformations were mainly ocular changes, neural tube defects, hydronephrosis and amelia (JECFA (2003)). In the dermal administration study using pregnant rats during the organogenetic period, the highest dose induced both maternal toxicity, containing lethality, suppression of body weight gain, and embryo/fetal toxicity, indicated by resorption, loss of embryos, reduction in mean litter size and various types of changes in internal organs and skeleton. The morphological changes were considered by the authors to be more severe than those that would occur merely as a secondary consequence of the maternal response (JECFA (2003)). Therefore, the substance was classified as Category 2.
8 Specific target organ toxicity - Single exposure Category 2 (liver, kidney), Category 3 (narcotic effects) Warning H371: May cause damage to organs (liver, kidney)
H336: May cause drowsiness or dizziness (narcotic effects)
P309+P311: IF exposed or if you feel unwell: 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.
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
In the acute oral toxicity study in rats (LD50 value: 650 - 1430 mg/kg), degeneration of the liver and kidneys was observed (IUCLID (2000)). In the liver, hyperemia and slight fatty change were observed (IUCLID (2000)). In the kidneys, tubular necrosis was found in the renal medulla, and cloudy swelling of tubular cells and cast formation were found in the renal cortex (IUCLID (2000)). In consideration of LD50 values, the findings were thought to belong to Category 2, thus, the substance was classified as Category 2 (liver, kidneys). Moreover, in the acute oral toxicity study in mice, most of the animals received 1.0 to 2.0 mg/kg exhibited narcotic effects within 1 and 5 minutes after administration (IUCLID (2000)). Category 3 (narcotic effects) was, thus, added.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In the 4-month oral (gavage) dose study in rats at the dose level of 51 mg/kg/day, increased activities of cholinesterase and ALT, and decrease in serum protein concentration were reported (JECFA (2003)). In the 30-day repeated oral dose study in rats, the changes at 200 mg/kg/day (converted dose level as that of 90-day study: 66.7 mg/kg bw/day) containing the damage to internal organs, increased hemoglobin and leukocyte count were reported (IUCLID (2000)). However, these studies were insufficient due to no referring to histopathological effects and no details of the results shown. Additionally, in the 13-week dermal toxicity study in rats, while decreases in hemoglobin concentration and leukocyte count were observed in males at 2040 mg/kg/day, no treatment-related histopathological effects were observed and any other toxicological effects were detected (PATTY, 5th (2001)). Although the "Not classified" category was concluded for dermal route, the classification for specific target organ toxicity (repeated exposure) was conclusively justified as "Classification not possible".
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) Not classified - - - - Classified as "Not classified" from its 48h-EC50 = 287 mg/L for crustacea (Daphnia magna) (IUCLID, 2000).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified as "Not classified" since its acute toxicity is "Not Classified" and it is not non-water soluble (water solubility: 22200 mg/L (PHYSPROP Database, 2011)).
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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