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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:
other information
Study period:
Jan 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well reported GLP study with some substance loss during application

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ZK 74.804
- Batch No.: BA 76.700

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye served as control
Duration of treatment / exposure:
test substance remained in the eye, eye was not rinsed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2 males and 2 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.6
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours

Any other information on results incl. tables

Results of the study

      Irritant Effects (Score)         
 Animal    24 h 48 h   72 h  Mean scores
 1(M)  Cornea 0 0.0
   Iris 1 0 0 0.3
   Conjunctiva (reddening) 2 0 0 0.7
   Conjunctiva (swelling) 1 0 0 0.3
 2 (M)  Cornea 0 0 0 0.0
   Iris 1 0 0 0.3
   Conjunctiva (reddening) 1 0 0 0.3
   Conjunctiva (swelling) 0 0 0 0.0
 3 (F)  Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 2 0 0 0.7
   Conjunctiva (swelling) 1 0 0 0.3
 4 (F)  Cornea 0 0 0 0.0
   Iris 1 0 0 0.3
   Conjunctiva (reddening) 2 0 0 0.7
   Conjunctiva (swelling) 1 0 0 0.3

On the application day all animals showed predominantly moderate local incompatibility reactions on the conjunctiva (including concjunctiva tertia and sclera) such as reddening, swelling and vessel injections. Additionally, all animals showed predominantly slight vessel injections of the iris, eyelid closure, slight secretion and reddening of the skin of the eyelid. On day 2 of the test 3 animals showed slight swelling of the margin of the eyelid. The findings decreased on day 2 and 3 of the test and all animals were without findings on day 4.

Applicant's summary and conclusion

Executive summary:

The single administration of AD-Cyanhydrin into the right eye of 2 male and 2 female rabbits with a volume of 100 mg/eye resulted in moderate local incompatibility reactions on the conjunctiva (including concjunctiva tertia andsclera) such as reddening, swelling and vessel injections and slight vessel injections of the iris, eyelid closure, slight secretion and reddening of the skin of the eyelid on the application day. All findings were transient with decreasing intensity from day 2 onwards and all animals were without findings on day 4.

The above mentioned findings were classified at that time as moderate local incompatibility reactions but according to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea, 0.3 for the iris and conjuntival swelling and 0.6 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating. However, it has to be mentioned that due to the low bulk density of the test substance the application volume was too big and a considerable amount of the test substance was lost after application. The remaining substance on the conjunctiva stuck together forming lumps of various size. Therefore, it was assumed that the observed findings were provoked by the physical characteristics of the compound and it was decided to perform another study using 10 mg test substance/eye only.