Fatty acids tall-oil, reaction products with acrylic acid, potassium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize, John H.: Dermal toxicity, "Appraisal of the safety of chemicals in foods, Drugs and Cosmetics", Association of food and drug officials of the US, 1959, pp 46-48

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids tall-oil, reaction products with acrylic acid, potassium salt

Molecular formula:

not applicable to UVCB substances

IUPAC Name:

Fatty acids tall-oil, reaction products with acrylic acid, potassium salt

Test material form:

solid: bulk

Details on test material:

- Name of test material (as cited in study report): Diacid 1550, K-salt (trade name: "H-240 100%")
- Physical state: amber solid
- Storage condition of test material: At room temperature in original, sealed container

Test animals

Species:

rabbit

Strain:

other: New Zealand Albino

Details on test animals or test system and environmental conditions:

The animals were kept under observation at least 7 days prior to experimental use, during which period they were examined with respect to their general health and suitability as test animals. The animals were housed in suspended, wire bottomed steel cages and mantained on a standard laboratory diet. Food and water were offered ad libitum.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: for each animal two sites were tested: one site abraded, one site intact

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL / site

Duration of treatment / exposure:

24 h

Observation period:

After treatment (24 h) the animals were observed one hour after removal of the test material and again after 72 hours

Number of animals:

6

Details on study design:

The test material was applied to the test sites on each rabbit according to the treatment procedure. Each test site was immediately occluded with a 2-inch square gauze patch which was secured with masking tape. The trunk of each animal was then wrapped with impervious plastic sheeting. The wrap held the patches in position and retarded evaporation of the test material during the 24 hour exposure period.
At the end of the 24 hours the plastic wrappings and patches were removed. In addition, all residual test material was removed by rinsing the test sites with lukewarm tap water (or a suitable solvent) and gentle rubbing. One hour after removal of the test material, each abraded and intact test site was examined and scored separately for erythema and edema on a graded scale of 0 to 4. After 72 hours the sites were again examinated and scored.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

3.3

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Abraded skin site

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Abraded skin site

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

3.3

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: abraded skin site

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: abraded skin site

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

3.3

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: intact skin site

Results 6

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

3.3

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: intact skin site

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: intact skin site

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

2.7

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: intact skin site

Results 9

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Remarks on result:

not determinable because of methodological limitations

Remarks:

only 24h and 72h values were reported

Results 10

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Remarks on result:

not determinable because of methodological limitations

Remarks:

only 24h and 72h values were reported

Any other information on results incl. tables

Sites with second degree chemical burns (noted as moderate to diffuse) were given maximum irritation scores of 4 for both erythema and edema to obtain a primary irritation score.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The primary irritation score found was 6.2 out of 8 for intact skin and the substance was scored as severly irritating to intact skin.

Executive summary:

The primary irritation score found was 6.2 out of 8 for intact skin and the substance was scored as severly irritating to intact skin. A slight reduction in scores between the 24 hour and the 72 hour reading was seen, but in lack of an observation period a final assessment about reversibility cannot be made.