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Toxicological information

Eye irritation

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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:
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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.