Registration Dossier
Registration Dossier
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EC number: 432-130-2 | CAS number: 119345-01-6
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity:
Rat (Wistar) m/f; LD50 > 2000 mg/kg bw [EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method), GLP]
Acute dermal toxicity:
Rat (Wistar) m/f; LD50 ≥ 2000 mg/kg bw (24h) [EU Method B.3, GLP]
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 4 %
- Doses:
- Male: 2000 mg/kg bw
Female: 2000 mg/kg bw - No. of animals per sex per dose:
- Male: number of animals 3
Female: number of animals 3 - Control animals:
- not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- not specified
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0 - Clinical signs:
- No clinical signs have been observed during the test.
- Body weight:
- No changes have been noted.
- Gross pathology:
- No effects on organs observed.
- Other findings:
- No other findings reported.
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU-GHS
- Conclusions:
- LD50 (rat) > 2000 mg/kg bw
The test substance showed no oral acute toxicity under the conditions of the test. - Executive summary:
The acute oral toxicity of the test substance has been determined in a GLP test with rats according to EU Method B.1 tris in a limit test. The LD50 value was > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The data has been extracted from ECHA databases. The files were first migrated from the SNIF (Structured Notification Interchange Format) format (used under Directive 67/548/EEC) into the IUCLID 5 format (used under the REACH Regulation) and represent all of the information that ECHA currently holds on this endpoint, which were submitted in the framework of a notification at least 12 years previously (as per Article 25(3)) for the substance with the same EC number for which you inquired.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 4 %
- Duration of exposure:
- 24 h
- Doses:
- Male 2000 mg/kg bw
Female 2000 mg/kg bw - No. of animals per sex per dose:
- Male 2000 mg/kg bw; Number of animals: 5
Female 2000 mg/kg bw; Number or animals: 5 - Control animals:
- not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- not specified
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- No clinical signs have been observed during the test.
- Body weight:
- Two female animals lost weight during the first week of observation.
- Gross pathology:
- No effects on organs observed.
- Other findings:
- No other findings reported.
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU-GHS
- Conclusions:
- LD50 > 2000 mg/kg bw
The test substance showed no dermal acute toxicity under the conditions of the test. - Executive summary:
The acute dermal toxicity of the test substance has been determined in a GLP test with rats (limit test) according to EU Method B.3. The LD50 value was > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The data has been extracted from ECHA databases. The files were first migrated from the SNIF (Structured Notification Interchange Format) format (used under Directive 67/548/EEC) into the IUCLID 5 format (used under the REACH Regulation) and represent all of the information that ECHA currently holds on this endpoint, which were submitted in the framework of a notification at least 12 years previously (as per Article 25(3)) for the substance with the same EC number for which you inquired.
Additional information
Acute oral toxicity:
The acute oral toxicity of the test substance has been determined in a GLP compliant limit test with rats according to EU Method B.1 tris, resulting in a LD50 > 2000 mg/kg bw and therefore the test substance does not need to be classified according to Regulation 1272/2008/EC.
Acute dermal toxicity:
The acute dermal toxicity of the test substance has been determined in a GLP compliant limit test with rats according to EU Method B.3, resulting in a LD50 > 2000 mg/kg bw and therefore the test substance does not need to be classified according to Regulation 1272/2008/EC
Justification for classification or non-classification
Acute oral toxicity:
The test material does not meet the criteria for classification and will not require labelling for oral toxicity in accordance with European Regulation (EC) No. 1272/2008.
Acute dermal toxicity:
The test material does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with European Regulation (EC) No. 1272/2008.
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