Tris(2-hydroxyethyl)ammonium salts of tall-oil fatty acids

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

other: semi-solid, wax-like (at 20°C)

Details on test material:

- Name of test material (as cited in the study report): WS400102

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Number and Sex: 3 males
- Animal supplier: S&K-LAP Kft., 2173 Kartal, Császár út 135, Hungary
- Age on day of dosing (Day 0): Ca. 12 weeks old (young adult)
- Weight prior to dosing (Day 0): Minimum 3051 g, maximum 3131 g
- Housing: Individual housing in AAALAC approved metal wire rabbit cages allowing for some
social interaction with rabbit(s) in adjacent cages
- Diet (ad libitum): Commercially available rabbit diet, AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Hungary
- Water (ad libitum): Tap water from municipal supply
- Acclimation period: 14 days prior to study start under laboratory conditions.

Water was regularly analysed for contaminants, detailed information on the diet was provided by the supplier. Water and diet used in the present study were not considered to adversely affect the purpose or integrity of the study.

ENVIRONMENTAL CONDITIONS

Controlled environment, environmental conditions were:
- Ventilation, air changes per hour: 15-20
- Temperature (°C): 20 +/- 3°C
- Relative Humidity (%): 30 to 65%
- Photoperiod (artificial lighting): 12 hrs day / 12 hrs night
Relative humidity and temperature at times slightly exceeding the upper target limits of 70% and 23°C, respectively were not considered to have compromised the integrity or validity of the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0,5 g
- Concentration (if solution): neat test material

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: dorsal thoracal region, approx. 6 cm2
- Type of wrap if used: sterile gauze pads

SCORING SYSTEM:
Erythema I Eschar formation
0 No erythema.
1 Very slight erythema (barely perceptible).
2 Well-defined erythema.
3 Moderate to severe erythema.
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth).

Oedema formation
0 No oedema.
1 Very slight oedema (barely perceptible).
2 Slight oedema (edges of area well defined by definite raising).
3 Moderate oedema (raised approximately 1 mm).
4 Severe oedema (raised more than 1 mm and extending beyond area of exposure).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 2 weeks

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 3 weeks

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 3 weeks

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 1 week

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 1 week

Any other information on results incl. tables

No symptoms of systemic toxicity were observed in the animals during the test period and no mortalitiy occured.

All areas to be treated with the test substance and all control areas were normal before the application.The control areas were normal at any observation time.

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (irritant) according to Regulation 1272/2008

Conclusions:

.