Registration Dossier
Registration Dossier
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EC number: 221-088-9 | CAS number: 3001-98-7
Endpoint summary
Administrative data
Description of key information
acute oral LD50 > 5000 mg/kg bw (OECD 425 limit test)
acute dermal LD50 > 2000 mg/kg bw (OECD 402 limit test); Each rat was symptom-free during the entire study. There was no evidence for an adverse effect.
acute inhalation toxicity: waived
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
- Study period:
- 2016-03-22 till 2016-04-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The results of the study allow the calculation of the oral LD50 of the test item and permit the test item to be ranked according to most classification systems currently in use.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000, 5000 mg/kg bw
- No. of animals per sex per dose:
- 2000 mg/kg: 1 female
5000 mg/kg: 3 female - Control animals:
- no
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality was observed during the study.
- Clinical signs:
- other: All animals were symptom free during the entire study.
- Gross pathology:
- No external or internal macroscopic findings were noted in study animals at necropsy on
Day 14. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item
AFLAMMIT PCO 962 was found to be greater than 5000 mg/kg bw in female
Crl:WI rats.
The study result triggers the following classification/labelling:
- Regulation (EC) No 1272/2008 (CLP): none
- GHS (rev. 6) 2015: unclassified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
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:
- 2016-03-17 till 2016-03-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- other: The test item was administered as a single dose without using any vehicle, but sufficient water was added to dampen the material to ensure good contact with the skin at the treatment.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality occurred after a 24-hour dermal exposure of AFLAMMIT PCO 962
administered at 2000 mg/kg bw to Crl:WI male and female rats followed by a 14-day
observation period. - Clinical signs:
- other: Each rat was symptom-free during the entire study. Local sign was not noted in any of the study animals.
- Gross pathology:
- No external or internal macroscopic findings were noted at a dose level of
2000 mg/kg bw at necropsy. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose (LD50) of AFLAMMIT PCO 962 after a single dermal
administration was found to be greater than 2000 mg/kg bw in male and female
Crl:WI rats.
Each rat was symptom-free during the entire study. There was no evidence for adverse effcet.
The study result triggers no classification/labelling:
- Regulation (EC) No 1272/2008 (CLP): none
- GHS (rev. 6) 2015: Unclassified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
Based on the available data, the substance is not classified for acute toxicity according to Regulation (EC) No 1272/2008.
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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