Reaction mass of 4-tert-butylphenyl diphenyl phosphate and bis(4-tert-butylphenyl) phenyl phosphate and triphenyl phosphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22/11/1983 - 16/12/1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study according to methodology comparable to OECD guideline 401. Several minor deviations from guideline. Performed under QA.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EPA 43:163, 37336-37402 (1978)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981 guideline

Deviations:

yes

Remarks:

see overall remarks

Principles of method if other than guideline:

Not relevant

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butylphenyl diphenyl phosphate; bis(4-tert-butylphenyl) phenyl phosphate; triphenyl phosphate

EC Number:

700-990-0

Cas Number:

68937-40-6

Molecular formula:

vary

IUPAC Name:

4-tert-butylphenyl diphenyl phosphate; bis(4-tert-butylphenyl) phenyl phosphate; triphenyl phosphate

Details on test material:

- Name of test material (as cited in study report): tertbutylphenyl diphenyl phosphate
- Physical state: liquid
- Sample description: Butylated Arylphosphate - 10141D0404

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, Portage, Michigan
- Weight at study initiation: males: 181-211 g; females: 151-174 g
- Fasting period before study: 16-18 hours



IN-LIFE DATES: From: not mentioned To: not mentioned

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bodyweight

Doses:

5000 mg/kg bodyweight

No. of animals per sex per dose:

10 males and 10 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: once to twice per day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy

Statistics:

No data

Results and discussion

Preliminary study:

Not relevant

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No male or female rats died during the observation period.

Clinical signs:

other: Males: Adverse clinical signs for all rats included mild to moderate depression, stained fur, diarrhea, reddish facial stains, and stained anogenital areas. The rats appeared normal by day 3. Females: Adverse clinical signs for all rats included mild to

Gross pathology:

Males: Ten rats were necropsied following termination on day 14. Observations included pleural membranes adhered to wall of thoracic cavity, pericardium and diaphragm; clear and/or creamy fluid in the lungs, and mottled lungs (1 rat).
Females: Ten rats were necropsied following termination on day 14 and appeared normal.

Other findings:

A total of ten rats were dosed with corn oil and served as vehicle controls. The only adverse clinical sign for all rats was mild diarrhea. The rats appeared normal within 5 (females) or 24 (males) hours. Rats appeared normal during necropsy.

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity (LD50) of Fyrquel LT towards rats is > 5000 mg/kg bodyweight.

Executive summary:

The acute oral toxicity of Fyrquel LT towards male and female rats was determined according to methodology comparable to OECD Guideline 401. Ten male and ten female rats were exposed to 5000 mg/kg bodyweight of the test substance and observed for 14 days. The LD50 (for both male and female rats) was found to be > 5000 mg/kg bodyweight under the conditions of this stud

Based on the results and according to the criteria outlined in regulation 1272/2008/EC (CLP/EU-GHS) Fyrquel LT does not have to be classified and has no obligatory labelling requirement for oral toxicity.