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Toxicological information

Eye irritation

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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:
1997-11-17 to 1997-11-23
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 Guidelines (EPA 798.4500, OECD 405, 92/69/EEC B.5 and MAFF 59 NohSan No. 4200) and was GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C20-C24 alkenes, branched and linear
- Substance type: Alkenes, C20-24
- Physical state: Straw coloured liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.48 to 2.93 Kg
- Housing: Individually housed in suspended metal cages
- Diet (e.g. ad libitum): STANRAB SQC Rabbit Diet; ad libitum
- Water (e.g. ad libitum): Mains drinking water; ad Libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20
- Humidity (%): 50 to 65%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single treatment; 72 hours
Observation period (in vivo):
1, 24, 48, and 72 hours
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, in a group of 3 rabbits
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Draize method of "Eye toxicity tests" (Draize, J.H.; 1977)

TOOL USED TO ASSESS SCORE: Light source from a standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
110
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Results for Group 1
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
110
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Results for Group 2
Irritant / corrosive response data:
In Group 1, conjunctival redness was noted in three treated animals at 1 hour of observation, while in Group 2, conjunctival redness was noted in two treated eyes at 1 hour of observation.

Any other information on results incl. tables

No corneal or iridial effects were noted during the study in either Group 1 or Group 2.Conjunctival redness was noted in three treated eyes and two treated eyes in Group 1 and Group 2 animals respectively, at the 1-hour observation. All treated eyes appeared normal at the 24-hour observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material , C20-C24 ALKENES, BRANCHED AND LINEAR is not irritating when instilled in rabbit eyes.
Executive summary:

In an acute eye irritation test, C20-C24 alkenes, branched and linear, was instilled into rabbit eyes with a single 0.1 mL volume in the conjunctival sac of the right eye. Irritation was assessed in both unwashed and washed eyes. Results were reported according to the numerical scoring system based on Draize (1977); irritation scores were weighted and averaged to calculate a Draize score. For both unwashed and washed rabbit eyes, conjunctival redness was observed at the 1 hour observation period. All treated eyes appeared normal at the 24-hour observation. This resulted in a Draize score of 0.0 and the test material was classified as not irritating to rabbit eyes.

 

This study received a Klimisch score of 2 and was classified as "reliable without restriction" because it was carried out according to Guidelines (EPA 798.4500, OECD 405, 92/69/EEC B.5 and MAFF 59 NohSan No. 4200) and was GLP compliant.