Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented and scientifically accpetable. Study conducted before the advent of GLP.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1948
Report Date:
1948

Materials and methods

Principles of method if other than guideline:
Measured volumes of undiluted fluid chemicals are placed on the center of the cornea of an ablino rabbit which has just previously been shown to have uninjured eyes, and 24-hours later observe the eye for gross evidence of injury and for corneal necrosis revealed by fluorescein stain. The
volumes used are 0.001, 0.005, 0.02. 0.1 and 0.5 mL.
GLP compliance:
no
Remarks:
Conducted prior to the advent of GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
No additional details on the test material.

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
No additional details on animals and environmental conditions.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
An excess of undiluted material.
Duration of treatment / exposure:
24-hour.
Observation period (in vivo):
After 24-hours.
Number of animals or in vitro replicates:
5 eyes.

Results and discussion

In vivo

Results
Irritation parameter:
cornea opacity score
Basis:
animal:
Time point:
other: 24-hour
Score:
ca. 2
Max. score:
10
Reversibility:
not specified
Irritant / corrosive response data:
Minor damage to the cornea resulted from the instillation of an excess of undiluted material. This result regulates the compound to Grade 2 in our
10-grade rating series comparable in activity to "Carbitol".

Any other information on results incl. tables

No additional information on results or tables are available.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Minor damage to the cornea resulted from the instillation of an excess of undiluted material. This result relegates the compound to Grade 2 in our
10-grade rating series comparable in activity to "Carbitol". Carbitol (Diethylene Glycol ethyl ether) is not classified as an eye irritant, therefore DIBC is not considered to be irritating
Executive summary:

Exposure to an excess of undiluted diisobutyl carbinol results in minor damage to the cornea. this result relegates the compound to Grade 2 in our 10 -grade rating series comparable in sensivity to "Carbitol".