2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol

Acute Toxicity: dermal

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

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

Test material information

Constituent 1

Reference substance name:

2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol

EC Number:

221-573-5

EC Name:

2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol

Cas Number:

3147-75-9

Molecular formula:

C20H25N3O

IUPAC Name:

2-(2H-1,2,3-benzotriazol-2-yl)-4-(2,4,4-trimethylpentan-2-yl)phenol

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 or test system 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:

other: No clinical signs of toxicity were observed up to the end of the observation period.

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