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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:
6th March 2000 - 13th March 2000.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hexyl Salicylate
- Molecular formula (if other than submission substance): C13H18O3
- Physical state: Colourless to light yellowish
- Lot/batch No.: Lab No. 01714 Batch number 50554361
- Stability under test conditions: At least one year
- Storage condition of test material: Cool and dry

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF Albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BI Pharma KG, 88397, Biberach.
- Age at study initiation: Not documented
- Weight at study initiation: 2.5 - 3.0 kg b.w.
- Housing: The rabbits were housed individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet (e.g. ad libitum): A pelleted complete rabbit diet "Altromin 2123" was available ad libitum.
- Water (e.g. ad libitum): The animals had free access to bottles with domestic quality drinking water acidifed with hydrochloric acid to pH 2.5 to prevent microbial growth.
- Acclimation period: At least one week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 10 air changes / hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

IN-LIFE DATES: From: To: Not documented

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml


Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
4 female rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with 20ml 0.9% sodium chloride solution.
- Time after start of exposure: After the first 24 hour reading

SCORING SYSTEM: Not documented

TOOL USED TO ASSESS SCORE: fluorescein and UV light to detect possible corneal damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
corneal opacity
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Remarks:
iris lesion
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness of conjunctiva
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
One hour following application, one test animal showed markedly deepened folds, congestion and swelling of the iris, moderate circumcorneal injection, reaction to light of iris, diffuse red crimson conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge different from normal. A second animal showed a diffuse red crimson conjunctiva with individual vessels not easily discernible a swelling above normal and a discharge different from normal. A third animal showed markedly deepened folds, congestion and swelling of the iris, moderate circumcorneal injection and detectable reaction of light, a diffuse red crimson conjunctiva with individual vessels not easily discernible and a swelling above normal. the fourth test animal showed a diffuse crimson red conjunctiva with individual vessels not easily discernible and a swelling above normal.
24 hours following application of the test substance, all four animals displayed conjunctiva with some vessels definitely injected and a swelling above normal. 48 hours after application of the test substance, one test animal showed some conjunctival vessels definitely injected. The three other animals were free of any signs of eye irritation. 72 hours after application of the test article, all four animals were free of any signs of irritation.
Other effects:
No other effects documented

Any other information on results incl. tables

No additional information

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test substance, Hexyl Salicylate, does not induce irritation of the eyes following its application. Based on these results, the test substance does not need to be classified according to Regulation EC No. 1272/2008.
Executive summary:

Hexyl salicylate was investigated for its ability to induce eye irritation. The test substance was applied undiluted to the left eye of each of 4 female SPF albino rabbits in a volume of 0.1ml. The right eye of each animal served as the untreated control. The eyes were examined and the changes graded according to a numerical scale at one, 24, 48 and 72 hours after dosing. The cornea, iris and conjunctivae were examined and scored based on their reactions to the test material. Slight to well-defined signs of irritation were observed in the treated eyes at the 1, 24 and 48 hour examination time-points. However, all effects were fully reversible and no signs of irritation were observed after 72 hours. Under the conditions of this study hexyl salicylate does not induce irritation of the eyes following its application. Based on these results, it does not need to be classified according to Regulation EC No. 1272/2008.