Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
Data available from in-vivo studies preformed before the in-vitro requirement.
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 12 to 23 June 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: modification of that described by J.H. Draize.
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Identification Number: 9083-5,5-9-86
Purity: not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: a suitable licensed dealer
- Age at study initiation: 3 months
- Weight at study initiation: approximately 2 kilograms
- Housing: housed in galvanized or stainless steel cages, in a temperature controlled room
- Diet (e.g. ad libitum): consisted of a growth and maintenance ration from a commercial producer. ad libitum
- Water (e.g. ad libitum): consisted of a growth and maintenance ration from a commercial producer. ad libitum
- Acclimation period: at least 3 days

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1ml
Duration of treatment / exposure:
the first six rabbits 24 hours, the remaining three 30 seconds
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):with sufficient lukewarm water at room temperature
- Time after start of exposure:The eyes of the first six animals remained unwashed for 24 hours. The eyes of the remaining three rabbits were irrigated 30 seconds following instillation of the test article.

SCORING SYSTEM:Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Mean of 24, 48 & 72 hrs
Score:
ca. 1.56
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: After 21 days all animals has a score of 4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Mean of 24, 48 & 72 hrs
Score:
ca. 0.83
Max. score:
1
Reversibility:
not reversible
Remarks on result:
other: The score of 1 persisited after 21 days in 5 of 6 animals.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Mean of 24, 48 & 72 hrs
Score:
ca. 2.11
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: The score of 1 persisted after 21 days in 5 of 6 animals.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Mean of 24, 48 & 72 hrs
Score:
ca. 3.17
Max. score:
4
Reversibility:
not fully reversible within: 21
Remarks on result:
other: Signs persisted after 21 days in 5 of 6 animals
Irritant / corrosive response data:
The results presented above relate to the 6 animals treated for 24 hours and exclude those exposure only for 30 seconds. Severe corneal opacity, iritis and conjunctivitis were observed.
Other effects:
Blanching, bloody discharge, fibrovascular connective tissue and nodular mass subjacent to meibomian gland were also evident throughout the observation period.

Any other information on results incl. tables

0.1mL, neat

Draize  Scores

Group

Hours

Days

24

48

72

4

7

14

21

Unwashed

37.7

36.3

37.2

38.3

60.7

83.3

72.2

30” Wash

32.3

31.0

32.3

30.7

32.7

18.0

13.3

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This test substance is a severe ocular irritant to rabbits under conditions of this test. The wash procedure reduced the severity of the irritation observed.