2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol

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: 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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Reference 2

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

Test material information

Constituent 1

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