Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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, only males tested)

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 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(limited documentation, maximal applicated volume > 20mL/kg bw)
Principles of method if other than guideline:
5 male rats per group fasted for 24 h were dosed with a 10% aqueous dispersion of the test substance. Signs of intoxication were documented and animals were necropsied at study termination.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

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:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 153 g
- Fasting period before study: 24 h

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10%

MAXIMUM DOSE VOLUME APPLIED: 100 mL/kg bw

Doses:
10,000; 5,000; 2,500; 1,250 mg/kg bw
No. of animals per sex per dose:
5 (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:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred in the highest dose group.
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 body weight (study initiation; study termination):
- 10000 mg/kg bw: 152; 255
- 5000 mg/kg bw: 153; 256
- 2500 mg/kg bw: 153; 257
- 1250 mg/kg bw: 154; 266
Weight gains were comparable in all dose groups.
Gross pathology:
Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU