Pentyl salicylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study in accordance with EU Method B.5 with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

: Too short observation period, however, no effects seen at 48 and 72 hour observation time points

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

25485-88-5

EC Number:

607-733-0

IUPAC Name:

25485-88-5

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Salicylsäurecyclohexylester
- Physical state: Colourless, oily liquid
- Analytical purity: 98.5%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Purity test date: not reported
- Lot/batch No.: S 010
- Expiration date of the lot/batch: not reported

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.8 to 2.9 kg
- Housing: individually in rabbit cages
- Diet (e.g. ad libitum): Altromin rabbit food 2023 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: about one month

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21
- Humidity (%): 45 to 50
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a volume of 0.1 mL of neat test substance was instilled into the right eye of each rabbit

Duration of treatment / exposure:

The test subtstance remained in the treated eye

Observation period (in vivo):

96 hours

Number of animals or in vitro replicates:

Six

Details on study design:

SCORING SYSTEM:
Opacity: degree of density (reading performed with the most dense area)
No ulceration or opacity = 0, Scattered or diffuse areas of opacity; details of iris clearly visible = 1, Easily discernible translucent area; details of iris slightly obscured = 2, Nacrous area; no details of iris visible; size of pupil barely discernible = 3; Opaque cornea; iris not discernible through the opacity = 4

Iris
Normal = 0, Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light = 1, Haemorrhage, gross destruction, or no reaction to light = 2

Conjunctivae
Redness: refers to palpebral and bulbar conjunctivae
Normal = 0, Some blood vessels hyperaemic (injected) = 1, Diffuse, crimson colour; individual vessels not easily discernible = 2, Diffuse beefy red = 3

Chemosis
Swelling: refer to lids and /or nictating membranes
Normal = 0, Some swelling above norma = 1, Obvious swelling, with partial eversion of lids = 2, Swelling, with lids about half closed = 3, Swelling, with lids more than half closed = 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours after instillation

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours after instillation

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours after instillation

Score:

0.17

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours after instillation

Score:

0.28

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

No findings were noted at ratings at observation time points at 48 and 72 hours after instillation. The test was terminated at 96 hours after instillation.

Other effects:

No other effects were reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance was not irritating to the rabbit eye.

Executive summary:

The eye irritation potential of the substance Cyclohexyl salicylate was studied under GLP in accordance with EU Method B.5. A volume of 0.1 mL of the neat substance was instilled into the right eyes of six healthy, adult male rabbits of the New Zealand White strain. Ratings of eye reactions were done 1 hour and 24, 48 and 72 hours after instillation. The substance was not corrosive to the rabbit eye. Slight reddening and swelling of conjunctivae was seen 1 and 24 hours after instillation. No findings were made at the observation time points at 48 and 72 hours after instillation. The test was terminated 96 hours after instillation. It was concluded that the test substance was not irritating to the rabbit eye.