Registration Dossier
Registration Dossier
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EC number: 402-950-5 | CAS number: 87826-41-3 CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A study summary was made available by ECHA under Article 25, Para 3, of EC Regulation 1907/2006.
- Qualifier:
- according to guideline
- Guideline:
- other: CEE B1
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: OFA-SD (Sprague Dawley)
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% (PV) aqueous sodium carboxymethyl cellulose
- Doses:
- 2000 mg/kg. bw.
- No. of animals per sex per dose:
- Male rats: 5
Female rats:5 - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male rats: 0/5
Female rats: 0/5 - Clinical signs:
- other: None
- Gross pathology:
- No abnormality of the organs observed at necropsy
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity of the substance in rats was greater than 2000 mg/kg.bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch reliability 2.
Additional information
Three reliable, GLP compliant, acute oral toxicity studies in rats are available, employing limit test dosages or 2000, 2100 or 5000 mg/kg.bw.. There were no deaths or any other toxic effects observed in any of the studies.
Justification for selection of acute toxicity – oral endpoint
Lowest LD50 limit value for three reliable, GLP acute oral toxicity studies, conducted according to EU Annex V test guidelines.
Justification for classification or non-classification
The test substance is not classified for acute oral toxicity, according to EU CLP criteria (Regulation No.1271/2008).
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.
