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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- suspension of the substance in 0.5% aqueous sodiumcarboxymethyl cellulose
- Doses:
- 2100 mg/kg bw
- No. of animals per sex per dose:
- Male: 2100 mg/kg bw; Number of animals: 5
Female: 2100 mg/kg bw; Number of animals: 5 - Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 100 mg/kg bw
- Based on:
- not specified
- Mortality:
- Male: 2100 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2100 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: There were no deaths and no signs of toxicity
- Gross pathology:
- Effects on organs: No effects were observed at necropsy.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 100 mg/kg bw
- Quality of whole database:
- Three studies available, GLP compliant, done according to EU-methods annex V, B1
Additional information
Acute oral toxicity: three studies are available, all of them following the EU Method B1. The results are respectively >2100 mg/kg bw, >2000 mg/kg bw and >5000 mg/kg bw showing a profile non toxic for this substance.
Justification for selection of acute toxicity – oral endpoint
see discussion
Justification for classification or non-classification
LD50 (oral)=2100 mg/kg bw. The value is above the limit 2000 mg/kg bw for classification. Therefore the substance is not classified for acute oral toxicity hazard.
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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