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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles. No GLP, but overall good documentation

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979
Reference Type:
secondary source
Title:
Phthalimide - CAS No: 85-41-6
Author:
OECD SIDS
Year:
2005
Bibliographic source:
SIDS Initial Assessment Report for 20th SIAM, UNEP Publications

Materials and methods

Principles of method if other than guideline:
500 mg of phthalimide moistened was applied to the skin (inside ear) of two rabbits for 24 hours. Animals were observed for 7 days
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of the study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):phthalimide
- Analytical purity: not reported

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: the animals were housed individually

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: no treatment, inside ear
Vehicle:
water
Controls:
not required
Amount / concentration applied:
amount: 500 mg
Duration of treatment / exposure:
24 hour(s)
Observation period:
7 days
Number of animals:
2
Details on study design:
TEST SITE
Fixation of the test substance was performed using adhesive bandage on the ear of the rabbit

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the exposure the test substance was washed away with water and soap/vegetable oil
- Time after start of exposure: 24 hours


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 0, 24, 48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 0, 24, 48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 0, 24, 48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 0,24, 48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No irritation was observed at any time point.
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Thyssen/Bayer AG (1979):

In a primary dermal irritation study, the skin irritation/corrosion potential of phthalimide was tested. 500 mg/animal of the test substance was applied to the inside of rabbit ear of 2 animals, for 24 hours and animals were observed for 7 days. Phathalimide resulted to be not irritating, as no edema and no erythema were seen at any time point.