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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

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: Observation time 7 days, short documentation, low dose 50 mg

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
1 male and 1 female New Zealand white rabbit, 50 mg/rabbit was applied into the conjunctival sac of one eye of each rabbit, observation time: 7 days, evaluation according Draize
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalic anhydride
EC Number:
201-607-5
EC Name:
Phthalic anhydride
Cas Number:
85-44-9
Molecular formula:
C8H4O3
IUPAC Name:
1,3-dihydro-2-benzofuran-1,3-dione

Test animals / tissue source

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Amount: 50 mg
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
No further data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
ca. 1
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48 h
Score:
1.5
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
>= 1
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: not measured/tested
Remarks:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
>= 0
Max. score:
2
Reversibility:
not specified
Remarks on result:
other:
Remarks:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
2
Reversibility:
not specified
Remarks on result:
other:
Remarks:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
2
Reversibility:
not specified
Remarks on result:
other:
Remarks:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
1.5
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
3
Reversibility:
not specified
Remarks on result:
other:
Remarks:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Other effects:
no data

Any other information on results incl. tables

Scores:
rabbit1 - rabbit2
cornea (maximal score 4):
1h: 1 - 1
24h: 1 - 1
day 2: 1 - 0
day 7: 0 - 0
transitional slight cloudiness of the cornea
Iris (maximal score: 2):
1h: 1 - 1
24 h and later: 0 - 0
conjunctiva, redness (maximal score 3):
1h: 2 - 2
24h: 1 - 2
day 2: 1 - 1
day 7: 1 - 1
conjunctiva, swelling (maximal score 4):
1h: 2 - 1
24 h and later: 0 - 0
lacrimation:
1h: 1 - 1
24 h and later day 14: 0 - 0
The cornea was temporary cloudy. The observed effects were not fully reversible during the 7 days observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Executive summary:

Method: 2 animals received a dose of 50 mg/animal in the conjunctival sac, postexposure period 7 days.

Result: Not fully reversible within 7 days, cornea temorarily in parts opaque.

Reference: Thyssen/Bayer AG (1979)