Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Remarks:
none
Controls:
yes
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hour
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Time point:
24/48/72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

Four of six animals reacted with very slight erythema. No edema were formed. No irritation effects were observed24 h post exposure.


AVERAGE SCORE
-Erythema: 0.67 at 60 minutes, 0 at 24, 48 and 72 hours.
-Edema: 0 at 60 minutes, 0 at 24, 48 and 72 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of this study Piperonyl Butoxide does not warrant classification as being irritating to the skin.