Registration Dossier
Registration Dossier
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EC number: 259-224-4 | CAS number: 54553-90-1
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)
- Guideline:
- other: Appraisal of the safety of chemicals in foods, drugs and cosmetics (FDA)
- GLP compliance:
- not specified
- Species:
- rat
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- CMC (carboxymethyl cellulose)
- No. of animals per sex per dose:
- 10 animals in total
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 7 400 mg/kg bw
- Based on:
- test mat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 7 400 mg/kg bw
Acute toxicity: via inhalation route
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)
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- a total of 10 animals
- Details on study design:
- TEST ORGANISMS:
- Strain: Hsd/Win:WU / SPF
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Weight at study initiation: 200-300 g
- Controls: no
ADMINISTRATION:
- Area covered: dorsolumbar region, 50 x 50 mm2 = approximately 10 % of
the body surface
- Concentration in vehicle: 40 g/100 ml (suspension)
- Total volume applied: 5 ml/kg bw
- Occlusion: semiocclusive gauze dressing
- Removal of test substance: after 24 hours with warm water and absorbent
paper
EXAMINATIONS:
- Mortality: twice daily
- Clinical signs: 30 minutes after dosing, hourly thereafter for about 6 hours,
once daily for next 14 days
- Dermal response: once a day for 14 days
- Body weights: days 0 (prior to dosing), 7, and 14
- Macroscopic examination: day 14 - Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- MORTALITY: There were no deaths.
- Clinical signs:
- other: CLINICAL SIGNS: There were no signs of systemic reaction to treatment. After removal of the dressing until the end of the study no skin irritations were noticed. Body weight gain was satisfactory in males but low in females, which is a physiological findi
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
With an LD50 (oral, rat) of 7400 mg/kg bw and an LD0 (dermal, rat) of > 2000 mg/kg bw, there is no requirement for classification
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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