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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report with restrictions (only one test concentration, occlusive dressing, limited data on test material, only 2 animals per dose and the skin of half of the animals was abraded, no GLP)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969
Reference Type:
other: Correspondence
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(only one test concentration, occlusive dressing, limited data on test material, only 2 animals per dose and the skin of half of the animals was abraded)
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)-4,6-ditertpentylphenol
EC Number:
247-384-8
EC Name:
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol
Cas Number:
25973-55-1
Molecular formula:
C22H29N3O
IUPAC Name:
2-(2H-benzotriazol-2-yl)-4,6-bis(1,1-dimethylpropyl)phenol

Test animals

Species:
rabbit
Strain:
other: Albino Rabbits
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult albino rabbits
- Weight at study initiation: Mean bodyweight of about 3 kg
- Housing: Individual cages
- Diet: standard rabbit ration
- Water (ad libitum)
- Acclimation period: At least 7 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- 24 hours before dermal application, the backs of the rabbits were shaved free of hair with electric clippers
- One rabbit of each sex was further prepared by making epidermal abrasions every 2 or 3 cm longitudinally over the area of exposure; the abrasions were sufficiently deep to penetrate the stratum corneum, but not cause bleeding.
- Area of exposure: Back
- % coverage: 10% of total surface-area
- Type of wrap if used: Impervious plastic sheeting securely taped in place to ensure intimate contact of epidermis and test material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The animals were thoroughly cleaned. No further details.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount: 3 g of the test substance prepared as cream with polyethylene glycol
- For solids, paste formed: yes
Duration of exposure:
24 hours
Doses:
1100 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: No details
- Frequency of weighing: At start and end of the study.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 100 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occured.
Mortality:
No mortality occured.
Clinical signs:
other: - Scarified animal sites: Behaviour normal, very slight erythema at 24 hours, reversible within 72 hours - Unscarified animal sites: Behaviour normal, very slight erythema and well-defined erythema at 24 hours, reversible within 72 hours This application
Gross pathology:
- Scarified animals: nothing unusual at autopsy
- Unscarified animals: nothing unusual at autopsy

Applicant's summary and conclusion