Oct-2-ene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-03-03 to 1982-03-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it was carried out according to or closely followed OECD 405 guideline and was GLP compliant.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

111-66-0

Molecular formula:

C8H16

Details on test material:

- Name of test material (as cited in study report): Neodene 8
- Substance type: C8 alpha olefin
- Physical state: Liquid
- Stability under test conditions: Stable

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ray Nichols Rabbitry
- Age at study initiation: Not reported
- Weight at study initiation: 2.2 kilograms to 3.0 kilograms
- Housing: Individual
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 to 21.1 °C
- Humidity (%): 30 to 65%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: From: 1982-3-3 To: 1982-3-24

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 millilitre
- Concentration (if solution): Undiluted (100%)

Duration of treatment / exposure:

Rabbits in the "washed" group had eyes flushed 30 seconds after exposure; rabbits in the "unwashed" group did not have eyes flushed.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

Nine total, three males in the "washed" group, three males and three females in the "unwashed" group

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): In three males using tap water
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Not reported

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 hour

Score:

4.7

Max. score:

110

Remarks on result:

other: Washed eyes

Results 2

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 hour

Score:

3

Max. score:

110

Remarks on result:

other: Unwashed eyes

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hour

Score:

0

Max. score:

110

Remarks on result:

other: Washed eyes

Results 4

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hour

Score:

0.3

Max. score:

110

Remarks on result:

other: Unwashed eyes

Irritant / corrosive response data:

The maximum mean total irritation score at 1 hour post-exposure was 3.0 out of 110 for unwashed eyes and 4.7 out of 110 for washed eyes. Irritation was so minimal that washing the eye with water increased irritation scores at one hour. No irritation effects were seen 48 hours post-exposure; all effects were fully reversible.

Other effects:

None reported

Any other information on results incl. tables

According to the final classification system provided by the report, 1 -octene is classified as "mildly irritating" to the rabbit eye based on the maximum mean total irritation scores at the 1-hour observation.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating according to EU CLP classification

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

1-octene is not classified as an eye irritant according to EU, based on the study results. There was no significant difference in irritation scores between washed and unwashed eyes and all effects were fully reversible within 48 hours.

Executive summary:

In a primary eye irritation study, 0.1 millilitre of 1 -octene, undiluted, was instilled into the conjunctival sac of the right eyes of six male and three female New Zealand White rabbits. Three males had their eyes washed 30 seconds post-exposure. Animals were then observed for 7 days. Irritation was scored by the method of Draize.

 

Mild irritation was noted 1 hour post-exposure in both washed and unwashed eyes. Irritation persisted to day 1 of the observation period, but was not noted on day 2 post-exposure. In this study, 1 -octene is not classified as an eye irritant based on EU classification.

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to or closely following OECD 405 guidelines and was GLP compliant.