Registration Dossier
Registration Dossier
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EC number: 926-000-9 | CAS number: 1180524-77-9
Endpoint summary
Administrative data
Description of key information
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- other: polyethylene glycol
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Sex:
- female
- Dose descriptor:
- other: LD50 cut-off
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- other: No clinical signs
- Gross pathology:
- no findings
- Other findings:
- none
- Executive summary:
The LD50 cut-off value is > 5000 mg/kg bw based on the result of a study performed according to OECD TG 423. The test dose of 2000 mg/kg was tolerated without any findings.
Reference
| Dose (mg/kg bw) | Toxicological results | Onset and duration of signs | Onset of mortality |
| (1st) 2000 | 0 / 0/ 3 | --- | --- |
| (2nd) 2000 | 0 / 0/ 3 | --- | --- |
Toxicological results:
number of dead animals / number of animals with signs after treatment / number of animals treated
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
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
- Study period:
- September 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Statistics:
- none: limit test
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no clinical signs, no effects on weight development and gross pathological findings
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- no noticable gross pathological findings
- Executive summary:
An acute dermal toxicity study was performed according to OECD TG 402. 2000 mg/kg of the test item was applied semiocclusive on 5 male and 5 female rats for 24 hours. No mortalities, no clinical signs, no effects on weight development and no gross pathological findings were observed during the 14 -days observation period. The resulting LD50 was therefore > 2000 mg/kg bw for both sexes combined.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Acute toxicity: oral
The LD50 cut-off value is > 5000 mg/kg bw based on the result of a study performed according to OECD TG 423. The test dose of 2000 mg/kg was tolerated without any findings. Acute toxicity: InhalationNo data available Acute toxicity: dermal
An acute dermal toxicity study was performed according to OECD TG 402. 2000 mg/kg of the test item was applied semiocclusive on 5 male and 5 female rats for 24 hours. No mortalities, no clinical signs, no effects on weight development and no gross pathological findings were observed during the 14 -days observation period. The resulting LD50 was therefore > 2000 mg/kg bw for both sexes combined.
Justification for selection of acute toxicity – oral endpoint
Only one study available
Justification for selection of acute toxicity – dermal endpoint
Only one study available
Justification for classification or non-classification
Acute toxicity: oral
The LD50 cut-off value is > 5000 mg/kg bw. (rat, female)
No classification required according to EU-Directive 67/548/EEC, Annex VI.
No classification required according to Regulation (EC) No 1272/2008, Annex I.
Acute toxicity: inhalation
No data available
No classification required according to EU-Directive 67/548/EEC, Annex VI.
No classification required according to Regulation (EC) No 1272/2008, Annex I.
Acute toxicity: dermal
The LD50 -value is > 2000 mg/kg bw (rat, male/female)
No classification required according to EU-Directive 67/548/EEC, Annex VI.
No classification required according to Regulation (EC) No 1272/2008, Annex I.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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