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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study with acceptable restrictions (partly limited documentation, only 0.05 mL applied).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Eye irritation was tested using an internal method (BASF test) similar to OECD405.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Vinylisobutylether
no further details

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Source: no data
initial weight: 3.04 kg (female) and 3.38 kg (male)
no further details

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: 1 drop physiological saline instilled into the other eye
Amount / concentration applied:
1 drop corresponding to appr. 50 mm³
Duration of treatment / exposure:
no washing
Observation period (in vivo):
10 minutes, 1, 3, 24, 48, 72 hours and 4, 7 & 8 days after instillation (raw data)
Number of animals or in vitro replicates:
2
Details on study design:
No washing of the test substance after 24 h (compare with OECD Guideline 405)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: no effects on cornea and iris
Irritant / corrosive response data:
No effects in control eye. No other effects (see Table below).
Other effects:
no

Any other information on results incl. tables

Eye irritation in rabbits after instillation of 0.05 ml undiluted test substance

Rabbit 1 (male) // Rabbit 2 (female)

Scoring according to OECD TG405

Time after application

Erythema

Chemosis

Opacity of the cornea

Iritis

Remark

10 min

1//1

0//0

0//1

0//0

smeary overlay in rabbit1

1 h

1//1

0//1

0//0

0//0

smeary overlay in rabbit 1&2

3 h

1//1

0//1

0//0

0//0

smeary overlay in rabbit2

24 h

0//1

0//1

0//0

0//0

-

48 h

0//0

0//0

0//0

0//0

-

72 h

0//0

0//0

0//0

0//0

-

4 days

0//0

0//0

0//0

0//0

-

8 days

0//0

0//0

0//0

0//0

-

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Undiluted test substance was only slightly irritant to the rabbit eye.
Executive summary:

Comparable to Guideline study with acceptable restrictions (partly limited documentation, only 0.05 ml applied).

Two Vienna White rabbits received instillation of one drop (appr. 50 mm³) of the undiluted test substance into the conjunctival sac. The other eye was treated with physiological saline for control. Scoring was performed 10 minutes, 1, 3, 24, 48, 72 hours and 4, 7 and 8 days after instillation. The reddening, edema or corneal opacity reached max. score 1 in both rabbits and was completely reversible in one rabbit after 24 h and in the other after 48 h.

Conclusion: Undiluted test substance was only slightly irritant to the rabbit eye.