Dodecene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1995-11-13 to 1995-11-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restrictions because it was conducted according to GLP guidance and OECD 405 guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C6-8

IUPAC Name:

Alkenes, C6-8

Details on test material:

This substance is very similar with regard to health endpoints to the substance being registered.
- Name of test material (as cited in study report): Shop C68 Internal Olefin
- Substance type: Alkenes, C6-8
- Physical state: Clear colourless liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield SPF Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Age at study initiation: 4 months old
- Weight at study initiation: 2.80 to 3.35 grams
- Housing: Housed individually in suspended stainless steel cages mounted in mobile batteries
- Diet (e.g. ad libitum): Pelleted rabbit food; ad libitum
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: Approximately 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 23
- Humidity (%): 40 to 70
- Air changes (per hr): 10 complete air changes/hr without re-circulation
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 millilitre
- Concentration (if solution): Not provided

Duration of treatment / exposure:

72

Observation period (in vivo):

1, 24, 48, and 72 hours

Number of animals or in vitro replicates:

3, including one sentinel animal

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data



SCORING SYSTEM: Appears to have used the Draize method of eye scoring (Draize, 1959).


TOOL USED TO ASSESS SCORE: Ophthalmoscope or pencil beam torch; fluorescein was used, if necessary, to
aid the examination of the cornea

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48, and 72 hours after instillation

Score:

ca. 0.2

Remarks on result:

other: The maximum score is not specified in the study report; it is usually 110 if using Draize eye irritation scoring system.

Irritant / corrosive response data:

Animals were reported to exhibit slight pain and irritation following instillation of the test material. Corrosive data not reported.

Other effects:

Besides initial pain and irritation followed by mild conjunctivitis, no other effects were reported.

Any other information on results incl. tables

Initial instillation of the test compound caused very slight initial pain response. All animals had very slight to slight conjunctivitis within an hour of treatment, but one animal showed persistent response at 48 hours. At 72 hours, all animals’ eyes appeared normal. The study authors concluded that under the study conditions, SHOP C68 internal olefin was a non-irritant to the eye.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Shop 68 was not considered irritating to rabbit eyes.

Executive summary:

Justification for Read Across

Several criteria justify the use of the read across approach to fill data gaps for Category C substances using Category D substance analogues. Category C is comprised of isomerised olefins.  Category D is comprised of isomerised olefins with a range of carbon numbers. Studies indicate that changing the carbon number or the location of the double bond, or adding branching does not measurably alter the mammalian health endpoints. There appears to be no critical difference across Category D isomerised olefins with a range of carbon numbers with regard to health endpoints. Toxicity concerns are low for acute exposure to Category D substances. Genotoxicity studies indicate that these materials are not mutagenic. There was no adverse systemic toxicity observed in a 90-day repeated oral dose study, in which rats were exposed to C20-24 branched and linear alkenes. As a result, all of the above tested mammalian toxicity endpoints indicate a low hazard potential for human health. There do not appear to be any toxicological differences between Category D isomerised olefins with a range of carbon numbers and Category C is comprised of isomerised olefins.  Therefore, read across between these two categories can be justified.

In an acute eye irritation study, three New Zealand White rabbits (sex note specified) were instilled with 0.1millilitre of Shop 68 in the right eye. The left eye served as control. Following test chemical instillation, the animals were observed for overt signs of toxicity for several minutes and were checked twice during the first hour after treatment and at regular intervals throughout the day and daily to ensure that the treated eyes did not exhibit infection or cause distress. Ocular irritation was scored at 1, 24, 48, and 72 hours after treatment using a method similar to the Draize (1959) eye irritation scoring system.

 

Initial instillation of the test compound caused very slight initial pain response. All animals had very slight to slight conjunctivitis within an hour of treatment, but one animal showed persistent response at 48 hours. At 72 hours, all animals’ eyes appeared normal. The study authors concluded that under the study conditions, SHOP C68 internal olefin was a non-irritant to the eye.

 

This study received a Klimisch score of 1 and is classified as “reliable without restrictions” because it was conducted according to GLP guidance and OECD 405 guidelines.

 

This study will influence the DNEL(s).