Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline, animal experimental study, predates implementation of GLP and guideline studies but contributing to a weight of evidence.

Data source

Reference
Reference Type:
publication
Title:
Toxicological studies of certain alkylated benzenes and benzene. Experiments on laboratory animals
Author:
Wolf MA, Rowe VK, McCollister DD, Hollingsworth RL and Oyen F
Year:
1956
Bibliographic source:
Arch Ind Health 14, 387-398

Materials and methods

Test guideline
Guideline:
other: Pre-guideline method
Principles of method if other than guideline:
Pre-guideline method: test substance instilled into right eye and irritation and corneal injury assessed.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
99.98% pure.

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: Albino rabbits
- Source: Heterogeneous stock raised at Dow Chemical Company, Biochemical Research Dept.
- Diet: Commercial diet, supplemented with alfalfa hay

ENVIRONMENTAL CONDITIONS: No details reported

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
Two drops of undiluted material (no further detail reported)
Duration of treatment / exposure:
Single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
Not reported

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
other: narrative score, no individual data
Time point:
other: all
Reversibility:
not specified
Remarks on result:
other: inflammation and slight swelling of the eyelids
Irritation parameter:
cornea opacity score
Basis:
other: narrative score, no individual data
Time point:
other: all
Reversibility:
fully reversible
Remarks on result:
other: very slight, transient corneal injury comprising questionable or just perceptible superficial necrosis involving less than 50% of the cornea
Irritant / corrosive response data:
No individual or mean data provided. Overall narrative description only.

Any other information on results incl. tables

Moderate conjunctival irritation (i.e. inflammation and slight swelling of the eyelids) and very slight transient corneal injury (i.e. questionable or just perceptible superficial necrosis in very small areas of the cornea) were recorded.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Benzene is considered to be mildly irritating to rabbit eyes.
Executive summary:

Instillation of benzene into the rabbit eye caused moderate conjunctival irritation and very slight, transient corneal injury. It is concluded that benzene is irritating to rabbit eyes and should be classified as Xi, R36. Under CLP it is proposed that the appropriate classification is Category 2, H319.