Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it appears to adhere to OECD 405 guidelines. There is no statement on GLP compliance because it was conducted prior to the implementation of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C12-16 alpha olefin blend
- Substance type: C12-16 alpha olefins
- Analytical purity: 98.5%

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Details regarding test animals and environmental conditions are not provided in the study report.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as control; in addition a group of six animals treated with 5% ivory soap solution also served as controls
Amount / concentration applied:
0.1 millilitre
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 male albino rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: Not applicable

SCORING SYSTEM:
Draize system of eye irritation scoring (Draize et al. 1944)


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24
Score:
ca. 1
Reversibility:
not specified
Remarks on result:
other: There was no chemosis in the treated eye during the 24 hour observation period.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0.7
Reversibility:
not specified
Remarks on result:
other: There was no chemosis in the treated eye during the 48 hour observation period.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 1.3
Reversibility:
not specified
Remarks on result:
other: There was no chemosis in the treated eye during the 72 hour observation period.
Irritant / corrosive response data:
The author report only mild, transient redness in the conjunctival tissue following test material instillation. No effects in the cornea or iris were reported.

Any other information on results incl. tables

All animals had mild transient redness of the conjunctivae. There were no effects to the cornea or the iris. Results were less severe than the 5% Ivory Soap solution treated group.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Not irritating according to EU CLP classification Criteria used for interpretation of results: EU
Conclusions:
C12-16 is not irritating to the eye.
Executive summary:

In a primary eye irritation study, the test material, C12 -16 alpha olefin blend was instilled into male albino rabbit eyes at 0.1 millilitres. After instillation, the upper and lower lids were held shut briefly to avoid loss of the test material. The exposed eyes were not washed after treatment and were examined at 24, 48, and 72 hours post treatment. In addition to the untreated eye serving as a control, six rabbits treated with 5% ivory soap solution also served as a control. All animals had mild transient redness of the conjunctivae. There were no effects to the cornea or the iris. Results were less severe than the 5% Ivory Soap solution treatment group. Based on the study results, the study author concluded that C12-16 was not irritating to the eye.

This study received a Klimisch rating of “reliable with restrictions” because it appears to adhere to OECD 405 guidelines. There is no statement on GLP compliance because it was conducted prior to the implementation of GLP.