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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:
From 11 March 2010 to 16 Sept 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Grimaud Frères Sélection S.A.S., La Corbière, Roussay, France.
- Age at study initiation: about 4 months old
- Weight at study initiation: mean body weight ± standard deviation of 3.321 ± 0.313 kg
- Housing: Pajon cages
- Diet (e.g. ad libitum): free access to 110 pelleted diet
- Water (e.g. ad libitum): water filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 50 ± 20%,
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: From 27 April 2010 To 03 May 2010

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye, which remained untreated, served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL on left eye
Duration of treatment / exposure:
For about one second by helding the lower and upper eyelids together
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: see the following scale (any other information on materials and methods incl. tables)

TOOL USED TO ASSESS SCORE: UV lamp, 0.5% sodium fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: max score a 1 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: max score a 1 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: max score a 1 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: max score a 1 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: max score a 1 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritant / corrosive response data:
A slight chemosis (grade 1) was noted in all animals on day 1. A slight or moderate redness of the conjunctiva (grade 1 or 2) was observed in all animals on day 1; persisting until day 2 in two of them. A clear discharge was recorded on day 2 in 1/3 animals.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions of the study, the test item 2-Ethylhexyl nitrate was slightly irritant when administered by ocular route to rabbits.
Executive summary:

Methods

The test item was first administered to a single male New Zealand White rabbit. Since the test item was not severely irritant on this first animal, it was then evaluated simultaneously in two other animals.

A single dose of 0.1 mL of the undiluted test item was instilled into the left conjunctival sac. The right eye was not treated and served as control.

The eyes were not rinsed after administration of the test item.

 

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration.

The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.

The interpretation of results was carried out according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations).

 

Results

A slight chemosis was noted in all animals on day 1. Slight or moderate redness of the conjunctiva was observed in all animals on day 1; persisting until day 2 in two of them. A clear discharge was recorded on day 2 in 1/3 animals.

Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for chemosis, 0.0, 0.3 and 0.3 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.

 

Conclusion

Under the experimental conditions of the study, the test item 2-Ethylhexyl nitrate was slightly irritant when administered by ocular route to rabbits.

However, according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item should not be classified as irritating to the eyes.