Registration Dossier
Registration Dossier
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EC number: 272-034-6 | CAS number: 68649-66-1
Endpoint summary
Administrative data
Description of key information
5 male and female (number not defined) Wistar rats were dosed orally by gavage. The oral LD50of REG 1 was higher than 5,110 mg/kg.
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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study with deficiencies (e.g body weights not reported)
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: Tragant (0,5 %)
- Doses:
- 5110 mg/kg
- No. of animals per sex per dose:
- 5 per dose
- Control animals:
- yes
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
5 male and female (number not defined) Wistar rats were dosed orally by gavage. The oral LD50of REG 1 was higher than 5,110 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 110 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of acute toxicity – oral endpoint
Only one study available
Justification for selection of acute toxicity – inhalation endpoint
data waiving, see chapter 5.2.1.2 of CSR or chapter 7.2.2 of IUCLID data set
Justification for selection of acute toxicity – dermal endpoint
data waiving, see chapter 5.2.1.3 of CSR or chapter 7.2.3 of IUCLID data set
Justification for classification or non-classification
The respective citeria are not met.
As a result the substance has not to be classified according to Regulation (EC) No 1272/2008 (CLP/GHS).
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.
