Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye 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 study report which meets basic scientific principles. OECD SIDS

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

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The eye irritation potential of phthalimide was evaluated by placing 50 mg of test substance in conjunctival sac of one male and one female white New Zealand rabbit. Animals were observed at 0, 24 hours, 2, 3 and 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
white New Zealand rabbits, weight 3 to 4 kg

Test system

Vehicle:
water
Controls:
not required
Amount / concentration applied:
amount: 50 mg
Duration of treatment / exposure:
single eye instillation
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
Compound was placed in the conjunctival sac of one male and one female white New Zealand rabbit. The eyes were not washed and animals were observed at 0, 24 hours, 2, 3 and 7 days.

SCORE SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 0, 24 h, 48 h, 7 d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 0, 24 h, 48 h, 7 d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 0, 24 h, 48 h, 7 d
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 0, 24 h, 48 h, 7 d
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 0, 24 h, 48 h, 7 d
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 0, 24 h, 48 h, 7 d
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 0, 24 h, 48 h, 7 d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 0, 24 h, 48 h, 7 d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No irritation (score =0) was observed at any timepoint
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 an acute eye irritation study, 50 mg of phthalimide (purity not stated) was placed in the conjunctival sac of two rabbits. Animals were observed for 7 days. Irritation was scored according to the method of Draize. No eye irritation was observed at any time point.