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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific principles, accepted for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Principles of method if other than guideline:
The test substance, as received, was held under an impervious cuff in continuous 24-hr contact with the closely clipped skin of New Zealand White rabbits.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Rocryl(TM) 410
- Purity: 99.2 %
Impurities: low boilers: 0.03 %
methacrylic acid: 0.2 %
high boilers: 0.99 %
propylene oxide: 5 ppm
propyleneglycol-
dimethacrylate : none detected
Inhibitor : hydroquinone monomethyl ether: 5 ppm
CB : 0.10 %
- Batch No.: JK-6673-2

Test animals

Species:
rabbit
Sex:
male

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Application: 24 hours, after the exposure time cuffs were removed and the test substance was gently wiped from the application sites with paper towels.
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
6 males
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Clinical signs:
No effects
Gross pathology:
No effects
Other findings:
Skin irritation: well defined erythema, no edema. The skin irritation was recovered on day 5 after dosing.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 was determined to be >5000 mg/kg.