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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
secondary source
Title:
The safety of Piperony Butoxide
Author:
Breathnach, R.
Year:
1998
Bibliographic source:
Jones, D.G. (1998) Piperonyl Butoxide The Insecticide Synergist, Academic Press, San Diego

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
Piperonyl butoxide
IUPAC Name:
Piperonyl butoxide

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: mineral oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
5 days a week for 3 consecutive weeks
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
100, 300, 1000 mg/kg bw/day
Basis:
no data
No. of animals per sex per dose:
5

Results and discussion

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: systemic effects
Dose descriptor:
NOAEL
Effect level:
100 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: local effects

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Desquamation and fissuring of skin - thickening and scab formation, moderate acanthosis, hyperkeratosis and chronic inflammation of the epidermis at 300 and 1000 mg/kg bw/day. Severity was dose dependent.

Applicant's summary and conclusion

Conclusions:
No systemic effects were observed, NOAEL was >1000 mg/kg bw/day.
For local skin effects the NOAEL was 100 mg/kg bw/day based on dose depedant skin effects at higher dose levels (desquamation and fissuring of skin - thickening and scab formation, moderate acanthosis, hyperkeratosis and chronic inflammation of the epidermis).
Executive summary:

Groups of rabbits (5 per sex and dose) received on 5 days per week for 3 consecutive weeks doses of 100, 300 or 1000 mg/kg bw.

No adverse systemic effects were observed. The systemic NOAEL was >1000 mg/kg bw/day.

For local skin effects the NOAEL was 100 mg/kg bw/day based on dose depedant skin effects at higher dose levels (desquamation and fissuring of skin - thickening and scab formation, moderate acanthosis, hyperkeratosis and chronic inflammation of the epidermis).

Loc