Acetic acid, C11-14-isoalkyl esters, C13-rich

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 July 1979 to 16 July 1979

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, C11-14-isoalkyl esters, C13-rich

EC Number:

283-740-9

EC Name:

Acetic acid, C11-14-isoalkyl esters, C13-rich

Cas Number:

84712-50-5

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

Acetic acid, C11-14-isoalkyl esters, C13-rich

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: The test substance was used as supplied.

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

The treated eyes were examined at 1, 2, 3, 5 and 7 days following instillation of the test material into the eyes.

Number of animals or in vitro replicates:

6 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test material was not washed from the eyes.
- Time after start of exposure: not applicable

SCORING SYSTEM: According to the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances".

TOOL USED TO ASSESS SCORE: no data

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: 1, 2, 4, 5, 6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The average ocular irritation score was 0.7 on day 1 post-instillation, then 0.0 for the rest of the observation period.

Other effects:

No other effects were observed.

Any other information on results incl. tables

Table 1: Individual daily scores.

Rabbit number	Irritation parameter	Readings day 1	Readings day 2	Readings day 3	Readings day 5	Readings day 7
1	Corneal opacity	0	0	0	0	0
1	Iris	0	0	0	0	0
1	Conjunctivae	0	0	0	0	0
1	Chemosis	0	0	0	0	0
2	Corneal opacity	0	0	0	0	0
2	Iris	0	0	0	0	0
2	Conjunctivae	0	0	0	0	0
2	Chemosis	0	0	0	0	0
3	Corneal opacity	0	0	0	0	0
3	Iris	0	0	0	0	0
3	Conjunctivae	1	0	0	0	0
3	Chemosis	0	0	0	0	0
4	Corneal opacity	0	0	0	0	0
4	Iris	0	0	0	0	0
4	Conjunctivae	0	0	0	0	0
4	Chemosis	0	0	0	0	0
5	Corneal opacity	0	0	0	0	0
5	Iris	0	0	0	0	0
5	Conjunctivae (discharge)	1	0	0	0	0
5	Chemosis	0	0	0	0	0
6	Corneal opacity	0	0	0	0	0
6	Iris	0	0	0	0	0
6	Conjunctivae	0	0	0	0	0
6	Chemosis	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the eye irritation study, conducted according to a protocol similar to OECD TG 405 and in compliance with GLP, the test substance, Acetic acid, C11-14-isoalkyl esters, C13-rich, was reported to be not irritating to rabbit eyes.