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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report Date:
1959

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Irritation of test material was examined following application to the eye.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No additional information available.

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
No additional information available.

Test system

Vehicle:
other: unchanged or in propylene glycol
Controls:
not specified
Amount / concentration applied:
0.005 ml undiluted and 0.5 ml of a 5 and 15% dilution in propylene glycol, respectively
Duration of treatment / exposure:
24 hr
Observation period (in vivo):
24 hr
Number of animals or in vitro replicates:
Unspecified in report
Details on study design:
Measured volumes of undiluted test chemical is placed on the center of the cornea of an albino rabbit which has just previously been shown to have uninjured eyes and twenty four hours later observed the eye for gross evidence of injury and for corneal necrosis by fluorescein stain.

Results and discussion

In vivo

Results
Irritation parameter:
other: No scores available
Remarks on result:
other: Instillation of 0.005 mL undiluted, as well as an excess (0.5 mL) of a 15% dilution in propylene glycol caused severe corneal necrosis of rabbit eyes. A 5% dilution was essentially harmless.
Irritant / corrosive response data:
Instillation of 0.005 ml undiluted, as well as an excess (0.5 ml) of a 15% dilution in propylene glycol caused severe corneal necrosis of rabbit eyes. A
5% dilution was essentially harmless.
Other effects:
No additonal information available.

Any other information on results incl. tables

No additonal information available.

Applicant's summary and conclusion

Conclusions:
Instillation of 0.005 mL in the eye of a rabbit resulted in severe corneal necrosis. However, as the study was not conducted according to current guidelines the results do not allow to classify according to EU criteria.
Executive summary:

The eye irritation potential of 2 -methylbutan-1-ol was examined. Instillation of 0.005 mL in the eye of a rabbit resulted in severe corneal necrosis.