Solvent naphtha (coal), xylene-styrene cut

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP status not known, near guideline study, published in peer reviewed literature, minor restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference

Reference Type:

publication

Title:

The toxicological properties of hydrocarbon solvents

Author:

Hine CH, Zuidema HH

Year:

1970

Bibliographic source:

Industrial Medicine 39, 215-200.

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Approximately 0.1 mL of test sample was instilled into the conjunctival sac of one eye of each of 6 rabbits (the other eye served as a control). Eye irritation was scored, according to the Draize numerical system) at 24, 48 and 72 hours.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

mixed xylenes

IUPAC Name:

mixed xylenes

Constituent 2

Reference substance name:

Xylene

EC Number:

215-535-7

EC Name:

Xylene

Cas Number:

1330-20-7

Molecular formula:

C8H10

IUPAC Name:

xylene

Details on test material:

C-8 aromatics (ortho, meta and para xylene; ethyl benzene; composition not defined). Boiling Range 138-141C.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

not stated

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

not stated

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

Approximately 0.1 mL test material was placed in the conjunctival sac of one eye of each rabbit, the other eye served as a control. Readings for eye irritation according to the Draize system were made at 24, 48 and 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: average eye irritation score

Basis:

mean

Time point:

other: 24 hours

Score:

5.33

Reversibility:

not specified

Results 2

Irritation parameter:

other: average eye irritation score

Basis:

mean

Time point:

other: 48 hours

Score:

6.33

Reversibility:

not specified

Results 3

Irritation parameter:

other: average eye irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

4.67

Reversibility:

not specified

Irritant / corrosive response data:

The "average eye irritation scores" were 5.33 at 24 hours, 6.33 at 48 hours and 4.67 at 72 hours. Irritation was confined to the conjunctiva, but all six rabbits were affected. The author concluded that mixed xylene is a moderate eye irritant.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: author's interpretation

Conclusions:

Mixed xylene appears to have some potential to cause eye irritation

Executive summary:

Approximately 0.1 mL of sample was placed in the conjunctival sac of one eye of each of six rabbits, the other eye serving as a control. Readings for eye irritation, according to the Draize system, were made at 24, 48 and 72 hours. The average eye irritation scores were 5.33 at 24 hours, 6.33 at 48 hours and 4.67 at 72 hours. Irritation was confined to the conjunctiva, but all six rabbits were affected. The study author concluded that mixed xylenes were moderately irritating to the eye, however, the equivalent classification according to EU or GHS schemes is not obvious.