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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid). The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored accoridng to Draize scoring system at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Additional readings are made, if necessary, at 14 and 21 days. Fluorescein (2%) staining is used to determine corneal injury before dosing and at readings after one day.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Glutaric anhydride
EC Number:
203-593-6
EC Name:
Glutaric anhydride
Cas Number:
108-55-4
Molecular formula:
C5H6O3
IUPAC Name:
glutaric anhydride
Test material form:
solid: crystalline

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
Dose applied directly to eyes. No indication of duration of exposure and no indication that eyes were washed after dosing. Thus it is not possible to accurately state the duration that the animals were exposed to the test substance.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
1.7
Max. score:
3
Remarks on result:
probability of moderate irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
1.7
Max. score:
3
Remarks on result:
probability of moderate irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
1.5
Max. score:
3
Remarks on result:
probability of moderate irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
7 d
Score:
0.3
Max. score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
21 d
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
1
Max. score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
0.8
Max. score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
0.7
Max. score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
7 d
Score:
0.5
Max. score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
21 d
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
2.2
Max. score:
3
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
2.5
Max. score:
3
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
1.7
Max. score:
2
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
7 d
Score:
0.8
Max. score:
2
Remarks on result:
probability of mild irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
0.6
Max. score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
21 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 21 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
2.7
Max. score:
3
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
2.3
Max. score:
3
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
1.5
Max. score:
3
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
7 d
Score:
0.3
Max. score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
21 d
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Instillation of 10 mg of sample into rabbit eyes resulted in moderate to severe corneal injury (opacity) in 5 of 6 animals. One treated eye had no corneal effects. Iritis was apparent in 6 eyes and moderate to severe conjunctival irritation developed in 6 rabbits. After 48 hours, all rabbits exhibited a pus-like ocular discharge. Two eyes had a normal appearance after 7 days. Corneal vascularization developed in one rabbit and another animal exhibited a hemorrhaged nictitating membrane. One animal died at 12 days. The treated eye of this animal had completely healed by 7 days. The death was not considered to be related to the treatment. By 14 days, 2 of the remaining 5 eyes had a normal appearance. Two others only had minor conjunctival irritation. All eyes were healed after 21 days.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance appears to have caused severe damage to the eyes that persisted through the first 72 hours after dosing. All lesions subsequently heald over the course of the observation period with no damage present at day 21. Due to the severity of the initial lesions and their persistance for more than 24 hours, this test material meets the criteria for classification as an eye irritant that may cause serious damage to the eyes.