Item | Information |
---|---|
CAS RN | 3648-21-3 |
Chemical Name | Di-n-heptyl phthalate |
Substance ID | m-nite-3648-21-3_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 molecule. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
6 | Flammable liquids | Not classified |
- |
- | - | Both flash points of 113 deg C [closed-cup] (MSDS (Sigma-Aldrich, 2012), GESTIS (Access on Apr. 2012)) and 224 deg C [closed-cup] (ICSC (J) (2003)) are above 93 deg C. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
7 | Flammable solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
9 | Pyrophoric liquids | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
10 | Pyrophoric solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid substances are not available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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). | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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 |
- |
- | - | It was classified as "Not classified" because the administration of 2,000 mg/kg to rats caused no death, and an LD50 value was > 2,000 mg/kg (JECDB (Access on Apr. 2012)). | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
4 | Skin sensitization | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | The classification is not possible due to no in vivo test data. Besides, as for in vitro tests, there is a report on negative results in both an Ames test and a chromosomal aberration test with Chinese hamster CHL cells (JECDB (Access on Apr. 2012)). | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
6 | Carcinogenicity | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
7 | Reproductive toxicity | Category 2 |
Warning |
H361 | P308+P313 P201 P202 P280 P405 P501 |
In a reproductive toxicity screening test in which male and female rats were orally dosed from 14 days before mating through mating for 42 days for males, and through gestation and parturition by day 3 of lactation for females, seven females died on gestational days 20-22 in the 1,000 mg/kg group, and decreased delivery index due to death was observed, but there were no changes in the other indexes of sexual function and fertility, also in offspring, no treatment-related effects were seen in developmental parameters, or in external examination (JECDB (2007)). On the other hand, in a test with mice given a single oral dose during a gestation period, increased embryonic/fetal mortality was found in all groups but the control group, and embryos in the group dosed with 7.5 mL/kg on day 8 had 100% resorptions. And increased external malformations were observed in fetuses in the groups dosed on day 8 or 9, which had many encephaloceles, eyelid opening, cleft palate, and missing toes. The groups dosed on day 10 or 11 had many abnormal tails, missing toes, and hematoma, their skeletal malformations/variations were seen in the skulls, vertebrae, ribs, and limb bones, and all fetuses in the group dosed with 2.5 mL/kg on day 8 had fused ribs (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)). From the above, no reproductive toxicity was observed in the one-generation reproductive test with rats, but in the developmental toxicity test with mice given a single oral dose during a gestation period, there are no descriptions of general toxicity in parent animals, and there is a report on increased embryonic/fetal mortality, 100% embryonic resorptions, increased external malformations, and increased skeletal malformations/variations. Therefore, it was classified in Category 2. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | In a single oral administration test with rats (OECD TG401, GLP) (doses 500, 1,000, 2,000 mg/kg bw), there was no death at any dose, and no effects of administering this substance were observed in general status observation, body weight changes, necropsy, or histopathological examination (JECDB (Access on Apr. 2012)). From the results, it corresponds to "Not classified" in the oral route, however, because effects of exposure in the other routes are unknown due to no data, it was classified as "Classification not possible" for specific target organ toxicity (single exposure). | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | In a 28-day repeated oral administration test with rats, as liver effects, prolongation of prothrombin time and activated partial thromboplastin time in males at or above 250 mg/kg, and histopathological lesions of centrilobular hypertrophy of hepatocytes, centrilobular fatty change of hepatocytes, and single-cell necrosis of hepatocytes in the centrilobular zone in males at 1,000 mg/kg, related to decreased serum beta-globulin fraction in the 1,000 mg/kg group, were observed. As kidney effects, an increase in urine protein positive cases in females at 1,000 mg/kg and increased blood urea nitrogen in males at 1,000 mg/kg were found, but no histopathological changes were seen. As effects on male genetic organs, histopathological examination revealed a loss of spermatogenic cells in the testis, and a decrease in sperms in the duct and the appearance of detached spermatogenic cells in the epididymis in the 1,000 mg/kg group (JECDB (Access on Apr. 2012)). From the above results, a change at 250 mg/kg/day (converted guidance value: 77.8 mg/kg/day) was limited to prolongation of prothrombin time and activated partial thromboplastin time in males, and other effects on the liver, kidney, and male genetic organs were findings all at 1,000 mg/kg/day (converted guidance value: 311 mg/kg/day), which exceeds the guidance values. Because effects near the upper limit of the guidance value range are unknown, it was classified as "Classification not possible." Besides, also in another 28-day repeated dose oral administration test with rats, liver effects such as increased GOT, GPT, and ALP, and hepatocellular hypertrophy and necrosis were observed, and a loss of spermatogenic cells and seminiferous tubular atrophy are reported as testicular effects (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)), but all were findings at high doses of 1,000 mg/kg/day (converted guidance value: 311 mg/kg/day) or above. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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) | Classification not possible |
- |
- | - | Because reliable data were not obtained at concentrations up to the water solubility, the classification is not possible. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Category 2 |
- |
H411 | P273 P391 P501 |
If chronic toxicity data are used, then it is classified in Category 2 due to being rapidly degradable (a degradation rate by BOD of phthalic acid, the hydrolysate: 85.2% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1976)), and 21-day NOEC = 0.040 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1995)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, it is impossible to determine the classification because reliable acute toxicity data were not obtained for fish and algae. By drawing a comparison between the above results, it was classified in Category 2. |
FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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