Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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

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Reference
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:
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 finding in rats at this age.
NECROPSY FINDINGS: No abnormalities were revealed by macroscopical
examination.
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