Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalimide
EC Number:
201-603-3
EC Name:
Phthalimide
Cas Number:
85-41-6
Molecular formula:
C8H5NO2
IUPAC Name:
1H-isoindole-1,3(2H)-dione
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 or test system 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
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.