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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
Study initiated: 2/23/81. Study terminated: 3/02/81
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
No reproducible, significant variation in local effects on skin and eye between members of the category have been reported but rather strong irritation or even corrosive effects. Therefore, the general hypothesis for the category approach that xylenol isomers exert qualitatively and quantitatively similar toxicity effects applies for the endpoint "eye irritation".

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL)
Available data for two xylenol isomers and a mixture of isomers indicate a mostly strong reactivity with tissues of skin and eye. All 6 isomers as well as xylenol (mixed isomers) are classified as Skin Corr. 1B with hazard statement H314 (Causes severe skin burns and eye damage) according to Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). See attached read-across justification for further information.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Range-finding eye irritation test in two rabbits (Draize test) with rating of irritation effects according to a classification system outlined in Dow Chemical Protocol 78P-103.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Male animals

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 ml (undiluted)
Duration of treatment / exposure:
7 days (eyes were not washed)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
0.1 ml of the test substance, as received, was introduced into the conjunctival sac. Eyes were not washed. Rating for irritation effects on cornea, iris and conjunctivae was performed 4, 24, 48, 72, and 96 hours, as well as 7 days after instillation of the test material according to a classification system outlined in Dow Chemical Protocol 78P-103.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2.5
Reversibility:
fully reversible
Remarks:
max score after 4 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
probability of mild irritation
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.6
Max. score:
14
Reversibility:
fully reversible within: 96 h
Remarks:
max score after 4 hours
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
not measured/tested

Any other information on results incl. tables

Time

Structure

Score

Rabbit 1

Rabbit 2

Mean

4 h

Cornea

Iris

Conjunctivae

0

0

4

0

2.5

14

0

1.3

9

24 h

Cornea

Iris

Conjunctivae

0

0

4

0

0

4

0

0

4

48 h

Cornea

Iris

Conjunctivae

0

0

0

0

0

2

0

0

1

72 h

Cornea

Iris

Conjunctivae

0

0

0

0

0

2

0

0

1

96 h

Cornea

Iris

Conjunctivae

0

0

0

0

0

0

0

0

0

7 d

Cornea

Iris

Conjunctivae

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based on the duration of the ocular effects only, the mixture of xylenol isomers was considered by the authors as "moderately" irritating to the eyes of rabbits (i.e., all ocular effects were reversible within 7 days, but not within 24 hr after dosing).
Executive summary:

The effect of a mixture of xylenol isomers on the eye was investigated in New Zealand White rabbits (SS_in vivo_Range finder study on eye irritation_rabbit_1982_Target). 0.1 ml of the mixture of xylenol isomers, as received, was introduced into the conjunctival sac. Eyes were not washed. Rating for irritation effects on cornea, iris and conjunctivae was performed 4, 24, 48, 72, and 96 hours, as well as 7 days after instillation of the test material according to a classification system outlined in Dow Chemical Protocol 78P-103. Irritation of iris and conjunctivae but no corneal opacity was observed. Rating of conjunctival effects 4 hours after installation of the test substance resulted in a score of 14 and 4, respectively. After 24 hours, a conjunctival score level of 4 was noted in both animals. All effects were fully reversible within 92 hours. Range-finding irritation data indicate this substance is "moderately" irritating to the eyes of rabbits.

This result can be transferred to the target test item 2,5-xylenol based on high structural similarities in the read-across category of xylenol isomers (see 'Read-across statement' in section 13.2).