Registration Dossier

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985
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

Constituent 1
Chemical structure
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:
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 dosed with 8 or 16 g/kg body weight, these signs of skin irritation generally persisted for the entire 14-day post-exposure period. For rabbits dosed with 2 g/kg body weight, signs of erythema, necrosis, and fissuring were present through Day 7; desquamation and scabs were still present at Day 14. (See Attached File 1: Table 2, Dermal Application, Single Dose to Rabbits).
Body weight:
Depressed body weight gains were apparent in the middle and high dose groups from Days 0 to 7 in comparison to the body weight gains exhibited from Days 8 to 14.
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)