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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:
May - December 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: valid guideline study performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl salicylate
EC Number:
204-263-4
EC Name:
2-ethylhexyl salicylate
Cas Number:
118-60-5
Molecular formula:
C15H22O3
IUPAC Name:
2-ethylhexyl 2-hydroxybenzoate
Constituent 2
Reference substance name:
SALICYLATE D'OCTYLE
IUPAC Name:
SALICYLATE D'OCTYLE
Test material form:
other: colorless liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Breeder: Grimaud frères selection S.A.S., La Corbière, Roussay, France.
Number: three animals were used, as recommended by the international guidelines.
Age/weight: on the day of treatment, the animals were 2 to 4 months old and had a mean body weight ± standard deviation of 2.8 ± 0.1 kg.
Acclimation: at least 5 days before the beginning of the study. Identification: individual metal ear tag.
The conditions in the animal room were set as follows:
• temperature: 18 ± 3 °C
• relative humidity: 30 to 70%
• light/dark cycle: 12 h/12 h
• ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals.
The animals were housed individually in Pajon cages (50 cm x 57 cm x 75 cm). Each cage was equipped with a food container and a water bottle.
During the study, the animals had free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
Food is analyzed regularly by the supplier for composition and contaminant levels. The diet formula is presented in the report.
Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analyses of water are performed regularly by external laboratories.
These analyses include the detection of possible contaminants (pesticides, heavy metals and nitrosamines).
No contaminants were known to have been present in the diet or drinking water at levels which may be expected to have interfered with or prejudiced the outcome of the study.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml of undiluted test item per eye
Duration of treatment / exposure:
The lower and upper eyelids were held together for about one second to avoid any loss of test item. The right eye, which remained untreated, served as control. The eyes were not rinsed after administration of the test item.
Observation period (in vivo):
The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test item.
The study was ended on day 4 in the absence of persistent ocular reactions.
Number of animals or in vitro replicates:
3 animals in total

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.6
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
A slight or moderate chemosis (grade 1 or 2) and a slight or moderate redness of the conjunctiva (grade 1 or 2) were observed in all animals on day 1. A slight chemosis was still observed on day 2 in 1/3 animals. Slight redness was noted until day 3 in 2/3 animals. No ocular reactions were observed on day 4.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.3, 0.0 and 0.0 for
chemosis, 0.7, 0.3 and 0.7 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.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the test item 2-ethylhexyl salicylate (SALICYLATE D'OCTYLE) was slightly irritant when administered by ocular route to rabbits. The criteria for classification according to CLP (regulation EC No 1272/2008) were not met.
Executive summary:

A slight or moderate chemosis and a slight or moderate redness of the conjunctiva were observed in all animals on day 1; A slight chemosis was noted on day 2 in one rabbit and slight redness of the conjunctivae persisted until day 3 in 2 animals. By day 4 all scores were down to zero, indicative of full reversibility. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.3, 0.0 and 0.0 for chemosis, 0.7, 0.3 and 0.7 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. Thus, the substance 2 -ethylhexyl salicyclate is not subject to classification acording to CLP (Regulation EC No 1272/2008).