[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

the number of animals and the procedure of dose finding were done with reference to OECD Guideline 423 due to animal welfare reasons.

Principles of method if other than guideline:

Three male and three female rats received a single dermal dose of 2000 mg Disflamoll DPK/kg bw. The animals were observed for mortality, clinical signs, and body weight during a 14 day period. A gross pathological examination was done on all animals at the end of the study.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diphenyl tolyl phosphate

EC Number:

247-693-8

EC Name:

Diphenyl tolyl phosphate

Cas Number:

26444-49-5

Molecular formula:

C19H17O4P

IUPAC Name:

methylphenyl diphenyl phosphate

Details on test material:

Disflamoll DPK; Diphenylkresylphosphate, 44% content, 340.3 g/mol molar mass; clear, colorless liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

The mean initial weight of males was 268 g and of females 213 g.

Administration / exposure

Type of coverage:

other: non irritant skin plaster

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3/sex/dose

Control animals:

not required

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Mortality:

no

Clinical signs:

other: no

Gross pathology:

no noticeable findings

Other findings:

no data

Any other information on results incl. tables

After administration of 2000 mg/kg bw no local signs and no clinical signs were observed; also the body weight development of male and female rats was not affected. No animal died and the animals sacrificed at the end of study showed no noticeable gross pathological findings. The LD50 was estimated to be greater than 2000 mg/ kg and was not exactly determined.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was estimated to be greater than 2000 mg/kg and was not exactly determined.

Executive summary:

Acute toxicological investigations of male and female Wistar rats were conducted after dermal exposure of Diphenylkresylphosphate (Disflamoll DPK). After administration of 2000 mg/kg bw no local signs and no clinical signs were observed; also the body weight development of male and female rats was not affected.

No animal died and the animals sacrificed at the end of study showed no noticeable gross pathological findings.

The LD50 was estimated to be greater than 2000 mg/kg and was not exactly determined.