GHS Classification Result (Revision of the past classification result)

Chemical Name:Paraffin wax
CAS:8002-74-2

Result:
ID: 21B3029
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

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 solids Classification not possible - - - - No data available.
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 applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - Auto-ignition point is 245 degC (NFPA (13th, 2002)) exceeding 70 degC.
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140 degC) 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 - - - - Organic compounds containing no oxygen, fluorine or chlorine
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
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 - - - - Based on LD50 values of >5000 mg/kg (IUCLID (2000)) and >3750 mg/kg (IUCLID (2000)) for rats, the substance was classified into "Not classified".
1 Acute toxicity (Dermal) Not classified - - - - Based on a LD50 value of >3600 mg/kg for rabbits (IUCLID (2000)), the substance was classified as "Not classified" in JIS Classification (correspond to Category 5 or "Not classified" in GHS classification).
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 - - - - There are results of "not irritating" and "slightly irritating" in rabbit Draize tests by 24-hour application (IUCLID (2000)). Additionally, there is a report that the substance produced slight erythema in only one of 20 volunteers in a human skin irritation test (IUCLID (2000)). Based on these data, the substance was classified as "Not classified".
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes 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.
Based on results of "slightly irritating" in a rabbit test resembling Draize test (IUCLID (2000)) and "mild irritating" in a rabbit standard Draize test (RTECS (2008); Journal of the American College of Toxicology. 3 (3), 43, 1984), the substance was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Classification not possible - - - - Classification not possible due to lack of data from in vivo mutagenicity tests. From in vitro mutagenicity tests, there is a report of a negative Ames test (in vitro mutagenicity test) (Pesticide safety information (Japan Crop Protection Association) (List open for the public) (1992)).
6 Carcinogenicity Classification not possible - - - - There is a report that no significant increase in the incidence of any tumour type was found in comparison with the control groups in a rat 2-year oral test, and a report that paraffin was not carcinogenic in a long-term animal test (JECFA (1993)). Additionally, there is a report that no carcinogenicity was observed in 2 year rabbit and mouse dermal exposure tests (EHC 20 (1982)). Since the result by oral administration was obtained from a single species, classification into "Not classified" is questionable, therefore, classification was not possible.
7 Reproductive toxicity Classification not possible - - - - No data available.
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 ...
Based on a report that wax fumes can cause mild irritation to eye, nose and throat (PATTY (5th, 2001)), the substance was classified into Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In a 90-day oral test in rats (0, 160, and 1600 mg/kg/day), decreased erythrocyte count and platelet count, vacuolated hepatocytes, development of microgranulomas and necrosis in the liver, development of microgranulomas and cell hyperplasia in the mesenteric lymph nodes, development of microgranulomas in the cervical lymph node, and increase in incidence of lymphoid-cell infiltrates in the base of the mitral valve were observed dose-dependently (JECFA 1056 (2003)). However, since the test was conducted at dose levels exceeding the upper limit guidance value range of Category 2, classification was not possible due to lack of sufficient data.
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) Classification not possible - - - - Classification not possible due to lack of data.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - - No data available.
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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