p-(1,1-dimethylpropyl)phenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Reference 2

Reference Type:

publication

Title:

ACUTE TOXICITY AND PRIMARY IRRITATION OF PARA-TERTIARY BUTYLPHENOL

Author:

Klonne DR, Myers RC, Nachreiner DJ & Homan ER

Year:

1988

Bibliographic source:

DRUG AND CHEMICAL TOXICOLOGY, 11(1), 43-54 (1988)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

- reliability scoring based on 1987 guideline

Deviations:

yes

Remarks:

- Humidity, temperature, housing condition not provided; no individual data.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butylphenol

EC Number:

202-679-0

EC Name:

4-tert-butylphenol

Cas Number:

98-54-4

Molecular formula:

C10H14O

IUPAC Name:

4-tert-butylphenol

Details on test material:

- Name of test material (as cited in study report): para-tertiary butylphenol, UCAR Butylphenol 4T-Flake (para tert-Butyl Phenol), PTBP.
- Physical state: White flakes.
- Analytical purity: Not reported.
- Lot/batch No.: Charge No. 496500; BRRC Sample No. 48-186.
- Expiration date of the lot/batch: Not reported.
- Stability under test conditions: Not reported.
- Storage condition of test material: Not reported.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Animals, Denver, PA.
- Age at study initiation: Not reported.
- Weight at study initiation: 2 to 3 kg.
- Fasting period before study: Not reported.
- Housing: Not reported.
- Diet (e.g. ad libitum): Animals were maintained on appropriate commercial diet, ad libitum.
- Water (e.g. ad libitum): Animals were maintained on municipal water, ad libitum.
- Acclimation period: At least 5 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Ground PTBP was moistened with distilled water and applied to the clipped skin of the trunk of 5 male and 5 female rabbits. The material remained in contact with the skin for 24 hour under an occlusive bandage covered with Vetrap (3M) Bandaging Tape using the method described by Myers et al. Rabbits remained in their cages with access to food and water during the contact period.

Duration of exposure:

24 hours.

Doses:

2, 8, and 16 g/kg body weight.

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During the observation period, rabbits were examined twice daily for signs of local inflammation and systemic toxicity. Body weights were measured on Days 0, 7, and 14.
- Necropsy of survivors performed: Yes.

Statistics:

Statistical analysis is not required (acute test).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: No LD50 determined

Remarks on result:

other: No mortalities were observed in animals tested at a level up to 16 g/kg body weight.

Mortality:

There were no mortalities in rabbits of either sex dosed with 16 g/kg body weight or less of PTBP.

Clinical signs:

other: The only sign of toxicity was prostration for one day of one female dosed with 16 g/kg body weight. However, there were signs of severe skin irritation (erythema, edema, fissuring, desquamation and/or necrosis) in both sexes of all groups. For animals d

Gross pathology:

There were no significant lesions in the abdominal or thoracic organs observed at necropsy.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)