Alkenes, C8-10-branched, C9-rich

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-11-13 to 1996-11-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it was compliant with GLPs, OECD guideline 405, and Annex to European Communities Council Directive 92/69/EEC Section B5.

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:

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, C11/C13/C14

IUPAC Name:

Alkenes, C11/C13/C14

Details on test material:

- Name of test material (as cited in study report): Shop 134
- Substance type: Alkenes, C11/C13/C14
- 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
- Weight at study initiation: 3.09 to 3.59 kilograms
- Housing: Housed individually in suspended stainless steel cages mounted in mobile batteries
- Diet (e.g. ad libitum): Standard pellet rabbit chow; ad libitum
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 23
- Humidity (%): 40 to 70
- Air changes (per hr): 10 air changes/hr
- 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): 0.1millilitre
- Concentration (if solution): Not specified

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24, 48, and 72 hours

Number of animals or in vitro replicates:

3; one animal served as a sentinel animal

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Seems to follow the Draize (1959) method of scoring eyes

TOOL USED TO ASSESS SCORE: Ophthalmoscope or pencil beam torch and fluorescein.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0.3

Reversibility:

not specified

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.

Other effects:

None

Any other information on results incl. tables

Very slight to slight conjunctivitis was observed in all animals one hour after exposure. Very slight conjunctival redness persisted in one animal and was observed at the 24- and 48-hour examinations. Iritis was observed in one animal at the 1-hour examination. At the 72-hour examination, there were no signs of ocular irritation. None of the animals exhibited a pain response to administration of the test material. Based on these results, SHOP C134 was considered to be a non-irritant to the rabbit eye.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Shop 134 was not considered irritating to rabbit eyes.

Executive summary:

In an eye irritation study, three New Zealand White rabbits (sex note specified) were instilled with 0.1mL of Shop 134 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.

 

Very slight to slight conjunctivitis was observed in all animals one hour after exposure. Very slight conjunctival redness persisted in one animal and was observed at the 24- and 48-hour examinations. Iritis was observed in one animal at the 1-hour examination. At the 72-hour examination, there were no signs of ocular irritation. None of the animals exhibited a pain response to administration of the test material. Based on these results, SHOP C134 was considered to be a non-irritant to the rabbit eye.

 

This study received a Klimisch score of 1 and is classified as “reliable without restrictions” because it was compliant with GLPs, OECD guideline 405, and Annex to European Communities Council Directive 92/69/EEC Section B5.