Icos-1-ene

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C12-14 α-

EC Number:

292-463-2

EC Name:

Alkenes, C12-14 α-

Cas Number:

90622-61-0

IUPAC Name:

90622-61-0

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

Results

Results 1

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.

Results 2

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.

Results 3

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.