3-methyl-2-butenyl salicylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1959

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-2-butenyl salicylate

EC Number:

271-434-8

EC Name:

3-methyl-2-butenyl salicylate

Cas Number:

68555-58-8

Molecular formula:

C12H14O3

IUPAC Name:

3-methylbut-2-en-1-yl 2-hydroxybenzoate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: 2.8 - 3.3 kg
- Housing: single cages
- Diet: standard laboratory diet for rabbits (Altromin, Lage)
- Water: e.g. ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C ± 2 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Observation period (in vivo):

1, 2, 4, 8, 24, 48, 72 and 96 hours until day 7

Number of animals or in vitro replicates:

5

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: UV

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Till 8 hours post application slight to clear conjunctival irritations could be observed with slightly increased redness, chemosis and slightly increased secretion. After 24 h these irritaitions were fully reversible. In the iris and cornea no changes could be detected.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to the eye.

Executive summary:

The potential of the test substance to cause eye irritation was tested in five rabbits according to OEDC 404 and GLP. The animals were treated with 0.1 mL test substance and observed for 7 days. The mean score for cornea opacity and iris were 0 for 24/48/72 h. Till 8 hours post application slight to clear conjunctival irritations could be observed with slightly increased redness, chemosis and slightly increased secretion. The conjunctivae score was 0 for 24/48/72 h. All effects observed were reversible within 24 h. Due to these results the test substance was found to be not irritating for the eye.