Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
November 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
- 4 instead of 3 animals

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye, which remained untreated, served as control.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
test substance remained in the eye (eye was not rinsed)
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
2 males and 2 females

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.58
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.17
Max. score:
4
Reversibility:
not fully reversible within: 3 days

Any other information on results incl. tables

Table 1: Results of the study

    

 Irritant effects (score)         

Animal no. (sex)

 Irritation parameter

24 h 48 h  72 h  Mean scores

 1 (M)

 Cornea

0 0.0
 

 Iris

0 0 0 0.0
 

 Conjunctiva (reddening)

1 0 0 0.33
 

 Conjunctiva (swelling)

0 0 0 0.0

 2 (M)

 Cornea

0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1 1 1 1
   Conjunctiva (swelling) 0 0 0 0.0

 3 (F)

 Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 0 0 0 0.0
   Conjunctiva (swelling) 0 0 0 0.0

 4 (F)

 Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1 1 1 1
   Conjunctiva (swelling) 1 1 0 0.66

The control eyes were without findings.

Local findings after single administration of the test substance into the conjunctival sac of the rabbit eye were slight to moderate reddening and slight to moderate swelling of the conjunctivae observed in all animals on administration day. From day 2 onwards slight conjunctival reddening was seen in three out of four animals until day 2, day 4 , day 6 and slight swelling was seen only in one out of four animals until day 3. Olle animal was without findings on day 2, one on day 3, one on day 5 and one on day 7.

The treatment did not result in any effect on body weight.

Applicant's summary and conclusion

Executive summary:

In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight irritation which was fully reversible 7 days after treatment at the latest. The calculation of mean values of the findings according to the system of evaluation recommended for the EU (1) revealed 0 for the parameter cornea and iris,0.17 for conjunctival swelling and 0.58 for conjunctival reddening.. According to EU classification criteria the test substance need not be labelled as an eye irritant.