Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 - 17 November, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is performed according to OECD Guideline 401 and EPA OPP 81-1 under GLP conditions. No deviations reported, although the identity and quality of the tested substance is not stated.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene

EC Number:

271-867-2

EC Name:

Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene

Cas Number:

68610-51-5

Molecular formula:

C10H12.C7H8O.C4H8

IUPAC Name:

2-(8-{3-[8-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-4-yl]-2-hydroxy-5-methylphenyl}tricyclo[5.2.1.0²,⁶]decan-4-yl)-6-[4-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-8-yl]-4-methylphenol

Details on test material:

- Name of test material (as cited in study report): Wingstay L
- Substance type: tan solid
- Physical state: solid
- Analytical purity: not stated in the report
- Impurities (identity and concentrations): not stated in the report
- Composition of test material, percentage of components: not stated in the report
- Purity test date: not stated in the report
- Lot/batch No.: 211093
- Expiration date of the lot/batch: May 2000
- Stability under test conditions: not stated in the report

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc., UK
- Age at study initiation: 7 weeks
- Weight at study initiation: 150 - 202 kg
- Fasting period before study: yes, before dosing
- Housing: Stainless individual steel cages during study period
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26° C, minor deviations
- Humidity (%): 40 - 70%, minor deviations
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/ml

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: based upon dose-range-finding and consultation with sponsor

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 4 hours, once daily through day 15, body weight on day 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Statistics:

Body weights are presented as mean plus std.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality occured.

Clinical signs:

other: Soft feces and/or poor grooming in some animals during day 1 - 3

Gross pathology:

Mottled kidneys in one male observed, no other visible lesions reported

Other findings:

none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information

Conclusions:

A study in 5 male and 5 female rats revealed that acute oral LD50 for Wingstay L was > 5000 mg/kg bw. The study was performed according to the general guidelines for acute oral toxicity under GLP conditions.