Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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

Constituent 1
Reference substance name:
mixed xylenes
IUPAC Name:
mixed xylenes
Constituent 2
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
other: average eye irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
5.33
Reversibility:
not specified
Irritation parameter:
other: average eye irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
6.33
Reversibility:
not specified
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.