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

Endpoint summary

Description of key information

In the key skin irritation study, conducted according to a protocol similar to OECD TG 404 and in compliance with GLP, the test substance, Acetic acid, C11-14-isoalkyl esters, C13-rich, was reported to be not irritating to intact or abraded skin of rabbits (Biosearch, 1979).

In the key 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 (Biosearch, 1979).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 July 1979 to 13 July 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Limited details reported in materials and methods section.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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 applied undiluted

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no data
- Preliminary purification step (if any): no data

Species:

rabbit

Strain:

other: albino rabbits

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- 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

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure: One side of the animals' backs was abraded and the other side was left intact.
- % coverage: a wide area
- Type of wrap if used: Gauze patches were placed over the treated area and an impervious material was wrapped around the trunk of the animals to hold the patches in place.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
24 and 72 hours

SCORING SYSTEM:
- Method of calculation: Draize

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

24 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Remarks:

Abraded skin

Basis:

mean

Time point:

24 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

erythema score

Remarks:

Abraded skin

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Time point:

24 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

Abraded skin

Basis:

mean

Time point:

24 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Remarks:

Abraded skin

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Other effects:

No other effects were recorded.

Table 1: Individual and average scores for erythema and eschar formation

Erythema	Reading (hours)	Rabbit No. 1	Rabbit No. 2	Rabbit No. 3	Rabbit No. 4	Rabbit No. 5	Rabbit No. 6	Average
Intact skin	24	0	1	1	1	1	0	0.67
Intact skin	72	0	0	0	0	0	0	0.00
Abraded skin	24	0	1	1	1	1	0	0.67
Abraded skin	72	0	0	0	0	0	0	0.00

Table 2: Individual and average scores for oedema formation

Oedema	Reading (hours)	Rabbit No. 1	Rabbit No. 2	Rabbit No. 3	Rabbit No. 4	Rabbit No. 5	Rabbit No. 6	Average
Intact skin	24	0	1	1	1	0	0	0.67
Intact skin	72	0	0	0	0	0	0	0.00
Abraded skin	24	0	1	1	1	1	0	0.67
Abraded skin	72	0	0	0	0	0	0	0.00

Interpretation of results:

GHS criteria not met

Conclusions:

In the skin irritation study, conducted according to a protocol similar to OECD TG 404 and in compliance with GLP, the test substance was reported to be not irritating to intact or abraded skin of rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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.

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

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

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

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

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

Irritation parameter:

conjunctivae score

Basis:

animal: 1, 2, 4, 5, 6

Time point:

24/48/72 h

Score:

0

Max. score:

3

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In the key skin irritation study, conducted according to a protocol similar to OECD TG 404 and in compliance with GLP, the test substance, Acetic acid, C11-14-isoalkyl esters, C13-rich, was reported to be not irritating to intact or abraded skin of rabbits (Biosearch, 1979).

Following a 24 -hour occluded topical application of 0.5 g undiluted test material onto the abraded and intact skin of the backs of 3 male and 3 female albino rabbits, the average erythema score at 24 and 72 hours was 0.67 and 0.0, respectively, based on the Draize scoring system. The average oedema scores at 24 hours for intact and abraded skin were 0.50 and 0.67, respectively and 0.0 at 72 hours. The treated skin area appeared normal by 72 hours. No other effects were reported.

An insult patch test/ photosensitisation study in human subjects was also available, in which the irritating, fatiguing and sensitising properties of Acetic acid, C11-14-isoalkyl esters, C13-rich were investigated (Biosearch, 1979). Based on the results obtained, it was concluded that the test substance was not a primary skin irritant or a fatiguing agent. No sensitisation reactions were noted. Exposure to UV-A light does not appear to initiate or increase the incidence or severity of irritation, fatigue or sensitisation.

In the key 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 (Biosearch, 1979).

Following a single instillation of 0.1 g of undiluted test material into the right eye of six albino rabbits, the average ocular irritation score was 0.7 at 24 hours and 0.0 at 48 and 72 hours. Only one animal had mean conjunctival score of 0.33 at 24, 48 and 72 hours based on "Illustrated Guide for Grading Eye Irritation by Hazardous Substances". No corneal opacity, iritis or chemosis were reported in any of the test animals. No other effects were reported.

Justification for classification or non-classification

Based on the available data for Acetic acid, C11-14-isoalkyl esters, C13-rich, no classification is required for skin or eye irritation according to Regulation (EC) No. 1272/2008.