Fatty acids, tall-oil, reaction products with triethanolamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to internationally accepted technical guideline and in compliance with GLP in recognized contract research organization. Despite some minor restrictions, the study report is fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

of 1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Certified by BAM according to DIN EN 45001.

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Number: 3 animals,
- Average bodyweight: 3 kg
- Housing: Individual housing in cages.
- Diet: Commercially available standard laboratory diet for rabbits ( Altromin, Lage, Germany).
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS

Room temperature kept constant at 18±2°C, the relative humidity at 50-60%. 12 hours illumination per day.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: undiluted (no vehicle) after warming the test material to 40°C

Controls:

not required

Amount / concentration applied:

0.5 mL test material (after warming it to 40°C) per approx. 6 cm2 skin (2.5 cm x 2.5 cm) per animal

Duration of treatment / exposure:

4 hours

Observation period:

7 days post patch removal

Number of animals:

3

Details on study design:

TEST SITE PREPARATION

Samples of 0.5 mL of the warmed test substance were applied to the shaved skin of albino rabbits and covered with gauze squares of the size 2.5 cm x 2.5 cm on the skin. Patches were fixed with adhesive plaster. Untreated shaved skin served as controls.

TREATMENT PERIOD AND REMOVAL OF TEST SUBSTANCE

Semi-occlusive treatment lasted 4 hours. Then the dressings were removed and residual test substance was dabbed off the skin with a wet towel.

Time points of skin evaluation:

The treated skin patches were evaluated at 1 hour post patch removal and at 24, 48 and 72 h and 7 days post patch removal. Only differences from controls were considered to be positive reactions. The scoring system for the grading of skin reactions is listed in Table 1 (next field below).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

as defined in Table 1

Basis:

mean

Remarks:

over 3 animals and 3 time points

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: erythema or scab formation was not evident

Results 2

Irritation parameter:

edema score

Remarks:

as defined in Table 1

Basis:

mean

Remarks:

over 3 animals and 3 time points

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: edma formation was not evident

Irritant / corrosive response data:

In each animal, erythema, scab or edema formation was not evident at any observation time point of the study.

Other effects:

Mortality or behavioural changes indicative of an adverse effect were not evident. Weighing of the animals at 7 days post treatment revealed normal body weight gain.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU