Registration Dossier
Registration Dossier
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EC number: 207-353-1 | CAS number: 464-45-9
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: Key study: The acute oral LD50 value of the test substance is 6500 mg/kg bw in rats.
Acute dermal toxicity: Key study: The acute dermal LD50 value of the test substance was >2000 mg/kg bw in rats.
Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route.
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: A scientific review (peer reviewed). No data on GLP.
- Principles of method if other than guideline:
- No data on test method
- GLP compliance:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 6 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: mean value of 5800-7200 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute oral LD50 value of the test substance is 6500 mg/kg bw in rats
- Executive summary:
According to the peer reviewed article, the acute oral LD50 value of the test substance is 6500 mg/kg bw in rats
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 6 500 mg/kg bw
- Quality of whole database:
- Key study with Klimisch score = 2
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:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to REACH Annex VIII, column 2: In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route.
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: A scientific review (peer reviewed). No data on GLP.
- Principles of method if other than guideline:
- No data on test method
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute dermal LD50 value of the test substance was >2000 mg/kg bw in rabbits.
- Executive summary:
According to the peer reviewed article, the acute dermal LD50 value of the test substance was >2000 mg/kg bw in rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Key study with Klimisch score = 2
Additional information
Acute oral toxicity: Key study: According to the peer reviewed article, the acute oral LD50 value of the test substance is 6500 mg/kg bw in rats
Acute dermal toxicity: Key study: According to the peer reviewed article, the acute dermal LD50 value of the test substance is greater than 2000 mg/kg bw in rats
Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route.
Justification for classification or non-classification
Based on the available data (LD50 (oral) = 6500 mg/kg bw and LD50 (Dermal) > 2000 mg/kg bw), the substance is not classified for acute toxicity according to CLP 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
