Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Chemical structure
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:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system 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:
other: No clinical signs of toxicity were observed up to the end of the observation period.
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