Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Test performed according to OECD of 12/05/1981

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD guideline of 12/05/1981
Principles of method if other than guideline:
Single exposure of 500mg of the substance on 6cm2 of closely cropped skin of 6 rabbits.
Continuous contact during 4 hours by means of semi occlusive plaster
Cutaneaous effects observed 1 hour after plaster take off then, daily observation (3 to 14 days)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Cream to white powder
Specific details on test material used for the study:
OP 1/87 SI

In vitro test system

Test system:
other: rabbits
Source species:
rabbit
Source strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Amount/concentration applied:
Single exposure of 500mg of the substance on 6cm2 of closely cropped skin of 6 rabbits
Duration of treatment / exposure:
4 hours

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Single exposure of 500mg of the substance on 6cm2 of closely cropped skin of 6 rabbits
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: rash
Run / experiment:
72 hours
Value:
ca. 0
Irritation / corrosion parameter:
other: oedema
Run / experiment:
72 hours
Value:
ca. 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No cutaneaous effects --> 9490 PERHYDROACIDE is non irritant or corrosive