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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable deviations. The study was performed prior to the implementation of OECD TG 405 and GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: 1h reading was not performed, observation period was 8 days (instead of 21 days)
Principles of method if other than guideline:
Study was performed prior to the implementation of OECD Guidelines and GLP, but is in compliance with the principles described in OECD Guideline 405. Deviations from the guideline were: 1-h reading was not performed, observation period was 8 days (instead of 21 days).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Imidazole
EC Number:
206-019-2
EC Name:
Imidazole
Cas Number:
288-32-4
Molecular formula:
C3H4N2
IUPAC Name:
1H-imidazole
Details on test material:
Imidazole from Aldrich, purity 99%

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Zuchtbetrieb M. Gauckler, 63065 Offenbach
- Weight at study initiation: mean 2.8 kg
- Diet (ad libitum): Ssniff K standard diet for rabbits and guinea pigs from INTERMAST GmbH, Soest, Germany
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: non-treated adjacent eye served as a control.
Amount / concentration applied:
Amount applied: volume of 0.1 ml
Duration of treatment / exposure:
After instillation of the test item the treated eye was not rinsed.
Observation period (in vivo):
Readings for eye irritation were done 24, 48 and 72 hours as well as 8 days after instillation.
The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The eyes were not washed out after 24 hours as specified in OECD Guideline 405

SCORING SYSTEM:
Scoring was performed according to the sytem descirbed in OECD 405.
Based on the scores the MMAS (Modified Maximum Average Score) was calculated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
other: secretion
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
other: secretion
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
other: secretion
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours after substance instillation
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritant / corrosive response data:
Application of 0.1g unchanged imidazole to the rabbit's eye (Draize test ; according to Federal Register 38 no. 178 § 1500 .42 (1973)) affected iris, conjunctiva, cornea, and the nictating membrane of the animals. Grade 2 reddening and swelling of the conjunctiva was noted along with chemosis which aggravated and persisted to grade 3 until day 8. A slight grade 2 cornea opacity persisted until the end of the observation period on day 8. The affected corneal area comprised more than 3/4.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information based on Regulation 1272/2008/EC
Executive summary:

Application of 0.1 g unchanged imidazole to the rabbit's eye affected iris, conjunctiva, cornea, and the nictating membrane of the animals. Grade 2 reddening and swelling of the conjunctiva was noted along with chemosis which aggravated and persisted to grade 3 until day 8. A slight grade 2 cornea opacity persisted until the end of the observation period on day 8. The affected corneal area comprised more than 3/4.

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