Item | Information |
---|---|
CAS RN | 78-79-5 |
Chemical Name | Isoprene |
Substance ID | m-nite-78-79-5_v1 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | To Guidance List |
UN GHS document (External link) | To UN GHS document |
FAQ(GHS classification results by the Japanese Government) | To FAQ |
List of Information Sources (Excel file) | List of Information Sources |
List of Definitions/Abbreviations | Definitions/Abbreviations |
Sample Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Sample SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | To OECD/eChemPortal (External link) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecules. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
6 | Flammable liquids | Category 1 |
Danger |
H224 | P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
Classified into Category 1 since flash point -54 degC (closed-cup) (ICSC (2004)) is <23 degC and initial boiling point 34 degC is <=35 degC. The substance containing stabilizers is classified into Class 3, PG I in UNRTDG (UN1218). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
7 | Flammable solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
8 | Self-reactive substances and mixtures | Type G |
- |
- | - | Classified into Type G since the usually distributed substance containing stabilizers is classified into Class 3, PG I in UNRTDG (UN1218) though there are chemical groups (unsaturated C=C)) associated with self-reactive properties present in the molecules. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
9 | Pyrophoric liquids | Not classified |
- |
- | - | Classified into Not classified from auto-ignition point 220 degC (ICSC (2004)). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
10 | Pyrophoric solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid substances are not available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified (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). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to liquid (low boiling point (34 degC) (ICSC (2004))) substances are not available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
17 | Desensitized explosives | - |
- |
- | - | - | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Not classified |
- |
- | - | Based on a LD50 value of 2,043 mg/kg for rats (SIDS (2005)), the substance was classified into "Not classified" in JIS Classification (correspond to Category 5 in GHS classification). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. As relevant information, a LD50 value is >1 mL/kg bw (681 mg/kg bw) for rats (SIDS (2005)). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
1 | Acute toxicity (Inhalation: Vapours) | Not classified |
- |
- | - | Based on a LC50 value of 180 mg/L/4h (64607 ppm/4h) for rats (SIDS (2005)), the substance was classified as "Not classified". Since the test concentration (63,600 ppm) was lower than 90% of saturated vapour pressure concentration (725,000 ppm), the classification criteria for gas were adopted. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | Based on results of "slightly irritating" in rabbits following prolonged or repeated application and application twice a day for 5 consecutive days (SIDS (2005)), the substance was classified as "Not classified" in JIS Classification (correspond to Category 3 in GHS classification). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 | P305+P351+P338 P337+P313 P264 |
Since slight irritation was found in the eyes of exposed human volunteers (Hazard Assessment Report (CERI, NITE) (2006)), the substance was classified into Category 2B. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
4 | Skin sensitization | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
5 | Germ cell mutagenicity | Category 2 |
Warning |
H341 | P308+P313 P201 P202 P280 P405 P501 |
Based on positive results in a peripheral erythrocyte micronucleus test by inhalation exposure to rats for 2, 13, 40 and 80 weeks (in vivo somatic cell mutagenicity test) (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005), NTP DB (2009)), the substance was classified into Category 2. As relevant information, negative results are reported from in vivo tests including a mouse pulmonary fibroblast micronucleus test and a mouse bone marrow chromosomal aberration test (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)). From in vitro mutagenicity tests, there are reports of a negative Ames test and a negative CHO cell chromosomal aberration test (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005), NTP DB (2009)). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
6 | Carcinogenicity | Category 2 |
Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
Based on the classifications of "2B" in IARC (IARC (1999)), "R" in NTP (NTP (2005)) and "2B" in Japan Society For Occupational Health (JSOH), the substance was classified into Category 2. In a 105-week inhalation test in rats, increases in the incidences of mammary gland fibroadenoma, mammary gland carcinoma, renal tubule adenoma and interstitial cell adenoma were observed (NTP TR486 (1999)). In a 80-week inhalation test in mice, increases in the incidence of tumours were found in the liver, kidney, spleen and Harderian gland (IARC vol. 71 (1999)). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
7 | Reproductive toxicity | Classification not possible |
- |
- | - | In developmental toxicity tests in rats and mice exposed by inhalation during the organogenesis period, there were no fetal developmental toxicity including teratogenicity (SIDS (2005)). Classification was not possible because of lack of sufficient data for effects on parental sexual function and fertility due to exposure prior to mating. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
8 | Specific target organ toxicity - Single exposure | Category 3 (narcotic effects, respiratory tract irritation) |
Warning |
H336 H335 |
P304+P340 P403+P233 P261 P271 P312 P405 P501 |
In a human sensory evaluation, mild irritation in the upper respiratory tract mucosa, larynx and throat were observed at a substance concentration of 160 mg/m3 (58 ppm) (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)). Human volunteers experienced irritation of the upper respiratory after exposure to a 60 ppm concentration of the substance (NTP TR486 (1999)). Based on the data, the substance was classified into Category 3 (respiratory tract irritation). The substance affects the central nervous system, and induces respiratory dysfunction and lowering of consciousness. In an inhalation exposure test in mice, loss of righting reflex and CNS depression were observed at high doses (97.5 - 125.3 mg/L) which were less than a lethal dose (PATTY (5th, 2001)). Based on the data, the substance was classified into Category 3 (narcotic effects). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, upper respiratory tract) |
Danger |
H372 | P260 P264 P270 P314 P501 |
In a 13-week inhalation test with mice, increased incidences of macrocytic anemia, hyperplasia of the forestomach, degeneration of the olfactory epithelium and cytoplasmic degeneration of the liver were observed (SIDS (2005)). In a 26-week inhalation test with mice (dose levels: 0.195 - 19.5 mg/L), increased incidences of hindlimb paralysis, spinal cord degeneration, degeneration of the olfactory epithelium, epithelial hyperplasia of the forestomach, and macrocytic anemia were observed. Grip strength of the hindlimb in the 220 ppm (0.613 mg/L) and higher concentration exposure groups was significantly lower than that in the control group (SIDS (2005)). After 26 week of recovery, the incidence of degeneration of the spinal cord was significantly increased in all treatment groups (SIDS (2005)). Since degeneration of the spinal cord is considered to be a cause of hindlimb paralysis and this effect occurred at dose levels within the guidance value range for Category 1, the substance was classified into Category 1 (nervous system). The significant increase in the incidence of degeneration of the olfactory epithelium was observed in the 220 ppm (0.613 mg/L) and higher treatment groups after 26 weeks of recovery. In isoprene rubber production workers, atrophic processes in the upper respiratory tract, catarrhal inflammation, and degeneration of the olfactory tract were noted (IARC vol. 71 (1991)). Based on these data, the substance was classified into Category 1 (upper respiratory tract). Since hepatocyte degeneration and hyperplasia of the forestomach were observed at dose levels exceeding the guidance value range for Category 2, the data were not used as the basis of classification. In a 2-week inhalation test in mice, a decrease in erythrocyte count and hemoglobin concentration was noted at dose levels of 438 ppm (90-day equivalence: 0.2 mg/L) (Hazard Assessment Report (CERI, NITE) (2006)). However, this data was not used as the basis of classification because of lack of other data for the effect on blood system. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | Category 2 |
- |
H401 | P273 P501 |
Classified into Category 2 from its 48h-EC50 = 3.2 mg/L for Crustacea (Daphnia magna) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2000). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Category 2 |
- |
H411 | P273 P391 P501 |
Classified into Category 2 since its acute toxicity is Category 2 and it is not rapidly degradable (BOD degradation rate: 2% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1988)). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in Annexes to the Montreal Protocol. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
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