Registration Dossier
Registration Dossier
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EC number: 248-315-4 | CAS number: 27194-74-7
Endpoint summary
Administrative data
Description of key information
Acute toxicity: Oral
LD50 > 2000 mg/kg bodyweight
Acute toxicity: Dermal
LD50 > 2000 mg/kg bodyweight
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:
- 19 January 2016 - 16 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- Physical state/Appearance: clear colorless liquid
Batch: 1023R26015
Purity: 100%
Expiry Date: 14 September 2019
Storage Conditions: room temperature in the dark - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Arachis oil for the 300 mg/kg dose level.
- Doses:
- 300 mg/kg body weight and 2000 mg/kg body weight.
- No. of animals per sex per dose:
- 300 mg/kg body weight: 1
2000 mg/kg bod weight: 5 - Control animals:
- not specified
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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:
- 28 January 2016 - 18 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 1023R25811
- Expiration date of the lot/batch: 14 September 2019
- Purity: 100%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none, used as supplied. - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- Single dose.
- Doses:
- 2000 mg/kgbody weight.
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
Acute toxicity: Oral
The test item was classified according to Annex 3 of the OECD Guidelines for Testing of Chemicals No.420 "Acute Oral Toxicity-Fixed Dose Method" (adopted 17 December 2001) as Unclassified.
Acute toxicity: Dermal
The test item was classified according to the GHS classification as unclassified.
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