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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29/06/1981 - 12/11/1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study according to methodology comparable to OECD guideline 402. 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:

1982

Report date:

1982

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

see overall remarks

Principles of method if other than guideline:

Not relevant

GLP compliance:

no

Test type:

fixed dose procedure

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:

rabbit

Strain:

other: Stauffland albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, California
- Weight at study initiation: 1234 - 1703 g



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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: abdominal skin
- Type of wrap if used: protective binder


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight
- Constant volume or concentration used: yes

Duration of exposure:

24 hours.

Doses:

2000 mg/kg bodyweight.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once or twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, local effects, necropsy

Statistics:

No data

Results and discussion

Preliminary study:

Not relevant

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortalities were recorded in either the control or treated group during the 14-day exposure period.

Clinical signs:

other: The only adverse clinical sign was mild depression. The rabbits appeared normal by day 1. Local dermal effects included mild erythema and edema (1 rabbit).

Gross pathology:

Ten rabbits were necropsied following termination on day 14 and appeared normal .

Other findings:

No data

Any other information on results incl. tables

Control animals

Four rabbits (2 male, 2 female) served as controls. They appeared normal throughout the 14 day test. There were no apparent local dermal effects following a 24 hour sham-treatment. Four rabbits were necropsied following termination on day 14 and appeared normal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal toxicity (LD50) of Phosflex 72B towards rabbits is > 2000 mg/kg bodyweight.

Executive summary:

The acute dermal toxicity of Phosflex 72B towards male and female rabbits was investigated according to methodology comparable to OECD guideline 402. Five male and five female rabbits were exposed to the test substance for 24 hours and observed for 14 days. The LD50 (for both males and females) was found to be > 2000 mg/kg bodyweight under the conditions of this study.

Based on the results and according to the criteria outlined in regulation 1272/2008/EC (CLP/EU-GHS) Phosflex 72B does not need to be classified and has no obligatory labelling requirement for dermal toxicity.