reaction mass of ethylbenzene and xylene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-guideline study, GLP status not known, animal experimental study, limitations in design and/or reporting but otherwise adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

unwashed eye

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

o-xylene

EC Number:

202-422-2

EC Name:

o-xylene

Cas Number:

95-47-6

Molecular formula:

C8H10

IUPAC Name:

o-xylene

Details on test material:

no further details

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no further details

Test system

Vehicle:

not specified

Controls:

not required

Amount / concentration applied:

no data

Duration of treatment / exposure:

1 h (not confirmed)

Observation period (in vivo):

1, 24, 48 and 72 hours, 4 and 7 days post instillation

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

no further details

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 hour

Score:

6

Max. score:

10

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Conjunctival redness (vessels definitely injected above normal to more diffuse, deeper crimson red, individual vessels not easily discernible) was noted in all 6 rabbits at 1 h post instillation of o-xylene. Conjunctival chemosis (swelling above normal) and conjunctival discharge (any amount above normal) were noted in 5 rabbits at 1 h post instillation. Phonation at instillation was noted in 4 rabbits. No corneal opacity or iritis was noted in any of the 6 rabbits. All ocular lesions had cleared by Day 7.

Any other information on results incl. tables

Eye Irritation Score Ranges and Means with Standard Deviations

Observation	Hours				Days
	1	24	48	72	4	7
Cornea
Mean	0.0	0.0	0.0	0.0	0.0	0.0
S.D.	0.0	0.0	0.0	0.0	0.0	0.0
Range	-	-	-	-	-	-
Iris
Mean	0.0	0.0	0.0	0.0	0.0	0.0
S.D.	0.0	0.0	0.0	0.0	0.0	0.0
Range	-	-	-	-	-	-
Conjunctivae
Mean	6.0	1.7	1.3	1.3	1.0	0.0
S.D.	2.2	0.8	1.6	1.6	1.1	0.0
Range	2-8	0-2	0-4	0-4	0-2	-
Total Score
Mean	6.0	1.7	1.3	1.3	1.0	0.0
S.D.	2.2	0.8	1.6	1.6	1.1	0.0
Range	2-8	0-2	0-4	0-4	0-2	-

Means based on six observations.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information not classified Criteria used for interpretation of results: EU

Executive summary:

Conjunctival redness (vessels definitely injected above normal to more diffuse, deeper crimson red, individual vessels not easily discernible) was noted in all 6 rabbits at 1 h post instillation of o-xylene. Conjunctival chemosis (swelling above normal) and conjunctival discharge (any amount above normal) were noted in 5 rabbits at 1 h post instillation. Phonation at instillation was noted in 4 rabbits. No corneal opacity or iritis was noted in any of the 6 rabbits. All ocular lesions had cleared by Day 7.