Registration Dossier

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: Comparable to guideline study with acceptable restrictions (limited documentation, no data on test substance purity)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(limited documentation, occlusive treatment), dose of 5000 mg/kg bw
Principles of method if other than guideline:
10 male rabbits were treated with a paste, prepared with the test substance and diethyl succinate, for 24 h under occlusive conditions. The skin was shaved before application. Signs of intoxication as well as skin irritation were documented and animals were necropsied at study termination.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Further characterisation: Albino rabbits
- Mean weight at study initiation: 2.88 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: diethyl succinate
Details on dermal exposure:
REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 5000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 (only males)
Control animals:
no
Details on study design:
- Duration of observation period following administration: no data
- Frequency of weighing: at initiation and termination of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the observation period.
Body weight:
Mean weight (study initiation; study termination):
- 5000 mg/kg bw: 2.88 kg; 3.13 kg
Gross pathology:
Necropsy revealed no substance-related findings.
Other findings:
Skin irritation:
Well-defined erythema were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met