Tall oil, potassium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 September 2005 to 16 September 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

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

Test material

Test material information

Constituent 1

Reference substance name:

Crude Tall oil

Molecular formula:

Not applicab;le as it is a UVCB.

IUPAC Name:

Crude Tall oil

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.9 to 2.1 kg
- Housing: Individually caged in metal wire cages, 79 x 59 cm bottom area, 38 cm high
- Diet (e.g. ad libitum): maintenance diet for rabbits, rich in crude fibre, ad libitum
- Water (e.g. ad libitum): Tap water, from an automatic watering system, ad libitum
- Acclimation period: 5 days for one animal; 12 days for the two remaining animals

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19.7 °C (continuous control and recording)
- Humidity (%): Average of 71.4 % (continuous control and recording)
- Photoperiod (hrs dark / hrs light): Artificial light from 6 am to 6 pm

IN-LIFE DATES: From: 5 September 2005 To: 16 September 2005

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

First the test material was administered to one animal. As no corrosive effect was observed in the initial test, the test material was administered to two additional animals one week later.

TEST SITE
Hair was clipped on the dorsal areas of the trunks one day before the application of the test material. The test sites were median on the dorsal thoracal region.
The test material was spread on gauze patches in a size of 2.5 cm2 and applied. The gauze was held in place by marginally fixing with non irritating tape and the application sites were covered semi-occlusively by a dressing (self adhesive non woven fabric, hypoallergenic). Access by the animals to the application sites was prevented by a plastic collar.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The tapes with the patches and the collars were removed and the residual test material wiped off using wet cellulose tissue.
- Time after start of exposure: Following the 4 hour exposure period.

OBSERVATIONS
The animals were examined once daily for other than local changes of the skin.
The treated areas were examined for erythema/eschar and oedema as well as for other local alterations (such as hyperplasia, scaling, discolouration, fissures, scabs and alopecia) approximately 1, 24, 48 and 72 hours after patch removal. No further examinations were performed thereafter.
The surrounding of the administration area, i.e. the untreated skin, served as a negative control.

SCORING SYSTEM:
Erythema/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) or 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)

The skin was examined using a cold light source KL 1500 electronic.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

No erythema/eschar or oedema was seen at any test site at any point throughout the observation period.
The control areas were normal at all observations

Other effects:

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Residual test material was noted on the exposed skin areas, resp. on the growing hair, until 72 hours post administration.

Any other information on results incl. tables

Table 1 Individual Scores

Time After Exposure (hours)	Erythema/Eschar			Oedema
	Animal Numbers			Animal Numbers
	11	12	13	11	12	13
1	0	0	0	0	0	0
24	0	0	0	0	0	0
48	0	0	0	0	0	0
72	0	0	0	0	0	0
Mean (24, 48 and 72 hours)	0.0	0.0	0.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the test substance was not irritating to rabbit skin.

Executive summary:

The acute dermal irritation potential of the test substance was investigated according to OECD Guideline 404 and EU Method B.4 under GLP conditions. 0.5 mL of the test substance was applied via a patch to a site about 2.5 cm2 on the intact skin of three New Zealand White rabbits and covered by a semi-occlusive dressing. After an exposure period of 4 hours, any residual test material was removed and the skin examined 1, 24, 48 and 72 hours following patch removal. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. No signs of erythema/eschar or oedema were noted. Under the conditions of this study, the test substance was not irritating to rabbit skin (Wolf, 2005).