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Toxicological information

Acute Toxicity: dermal

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
no
Body weight:
not affected
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.