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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:
Feb 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

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

Test material

Constituent 1
Reference substance name:
17 alpha-Cyanomethyl-17 ß-hydroxy-5(10)-estren-3-one
IUPAC Name:
17 alpha-Cyanomethyl-17 ß-hydroxy-5(10)-estren-3-one

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

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
mean
Time point:
24/48/72 h
Score:
0.42
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 2 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 1 0 0.67
 

 Conjunctiva (swelling)

0 0 0 0.0

 2 (M)

 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

 3 (F)

 Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1 0 0 0.33
   Conjunctiva (swelling) 1 0 0 0.33

 4 (F)

 Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1 1 0 0.67
   Conjunctiva (swelling) 1 0 0 0.33

The control eyes were without findings.

Local findings after single administration of ZK 37877 into the conjunctival sac of the rabbit eye wereslight to severereddening and slight to moderate swelling of the conjunctivae in all animals on administration day. On day 2 slight reddening and/or swelling of the conjunctivae occurred in 3 out of 4 animals. All animals were without findings 72 hours after instillation of the test substance.

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 to moderate irritation of the conjunctivae from administration day on up to day 2 and were fully reversible 72 hours after administration. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameters cornea and iris, 0.17 for conjunctival swelling and 0.42 for conjunctival reddening . According to EU classification criteria ZK 37877 need not be labelled as an eye irritant.