Registration Dossier

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:
29 July 1981 - 12 August 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4236-43-15
- Physical state: liquid
- Analytical purity: responsibility of the Sponsor
- Stability under test conditions: responsibility of the Sponsor

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: H.A.R.E Rabbits for Research, Hewitt,New Jersey.
- Age at study initiation: adult
- Weight at study initiation: 2-4 kg
- Housing: individually housed in wire mesh bottom cages in an environment-controlled room
- Diet (e.g. ad libitum): NIH Animal Feed A (certified), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min.5d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): according to the "Guide for the Care and Use of Labolatory Animals"
- Humidity (%): according to the "Guide for the Care and Use of Labolatory Animals"
- Air changes (per hr): 12-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h dark/12h light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: OECD 405: untreated eye of the test animal serves as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:
no wash-out
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: observation: Draize scale for Scoring Ocular Lesions and Modification of the Kay and Calendra

TOOL USED TO ASSESS SCORE:
sodium fluorescein and ultraviolet lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
1.89
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Remarks on result:
other: Chemosis scoring increased to max. score at 14 days reading
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: All eye tissue surrounding the eyeball itself was completely necrosed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: days
Remarks on result:
other: All eye tissue surrounding the eyeball itself was completely necrosed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: All eye tissue surrounding the eyeball itself was completely necrosed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: All eye tissue surrounding the eyeball itself was completely necrosed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: All eye tissue surrounding the eyeball itself was completely necrosed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: All eye tissue surrounding the eyeball itself was completely necrosed
Irritant / corrosive response data:
Conjunctiva of the eye showed necrosis after 1 hour. All eye tissue surrounding the eyeball itself was completely necroses and colored black after 24 hours and later. One rabbit showed a hemorraged eye after 1 hour. Bloody discharge from the eye was observed in this rabbit after 7days, while the others showed no discharge.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the results of this study the test substance can be regarded as causing serious eye damage.