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

Skin irritation / corrosion

Administrative data

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.

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 404 (Acute Dermal 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 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

Test animals

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Results 3

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

Results 4

Irritation parameter:

erythema score

Remarks:

Abraded skin

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Results 5

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

Results 6

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Results 7

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

Results 8

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.