Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24hours
Doses:
2.0 g/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities were observed during the test period.
Clinical signs:
Well defined erythema and very slight to slight edema were found after unwrapping at 24 hours after treatment. From day 3 onwards (one female after day 7) no clinical signs were visible any longer.
Gross pathology:
No gross abnormalities were observed in any of the animals necropsied 14 days after treatment.

Any other information on results incl. tables

No mortalities were observed during the test period. Very slight to well-defined erythema and very slight to slight edema were found after unwrapping at 24 hours after treatment. From day 2 onwards no clinical signs were visible any longer with the exeption of one female where irritation persisted until day 7. In addition no gross abnormalities were observed in any of the animals necropsied 14 days after treatment

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Piperonyl butoxide is of low dermal acute toxicity. The dermal LD50 of Piperonyl Butoxide was determined to be greater than 2000 mg/kg b.w.