Fatty acids, C18-unsatd., trimers, reaction products with triethylenetetramine

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:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

of 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

of 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

of 1998

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese MAFF Test Data for Registration of Agricultural Chemicals, Skin Irritation (2-1-4), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): WS400152

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Stock supply of healthy adult rabbits
- Number and Sex: 3 females
- Age on day of dosing (Day 1): 22 - 36 weeks
- Weight prior to dosing (Day 1): Minimum 3.92 kg, maximum 4.66 kg
- Housing: Individual housing in plastic cages with peforated floor
- Environmental enrichment: Small soft white untreated wood blocks
- Diet : Standard laboratory rabbit diet (125 g/animal/day). In addition, dietary supplement of hay.
- Water: Drinking water, ad libitum
- Acclimation period: 6, 9 or 23 weeks prior to study start under laboratory conditions.

Routine analysis of the batch of diet used for nutrients, possible contaminants and microorganisms and of the drinking water were conducted or available at the testing facility.


ENVIRONMENTAL CONDITIONS

Air conditioned animal room set at:
- Temperature (°C): 18 ± 2°C
- Relative Humidity (%): 40 to 70%
- Photoperiod: 12 hrs artificial light per 24 hrs

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping from the dorsolumbar region

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

ca. 0.5 g undiluted liquid test material per approx. 6 cm2 skin

Duration of treatment / exposure:

Animal # 1: Three exposures of 3 minutes, 1 hour or 4 hours in sequential order to act as a preliminary screen.
Animals # 2 & 3: 4 hours

Observation period:

7 days post patch removal

Number of animals:

3 females

Details on study design:

TEST SITE PREPARATION AND ADMINISTRATION
On the day before treatment, hair was removed with clippers from the dorsolumbar region of each animal. The neat test substance was administered under a 2-ply 25 mm x 25 mm porous gauze pad secured with 'blenderm' surgical tape to intact skin sites. For exposures of one hour or more each treatment site was covered additionally with cotton wool and "Tubigrip" elasticated bandage dressing for the duration of the exposure period.

On each animal an additional site was similarly treated with the exception of test substance and acted as a control.

REMOVAL OF TEST MATERIAL
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with lukewarm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.

SKIN EVALUATION:
The treated skin patches were evaluated immediately after patch removal (for 3 minute and 1 hour exposures) and at 1, 24, 48 and 72 h afterwards, whereby only the data for the 4 hour exposures were reported. This was followed by daily evaluation of the skin reactions until Day 8 (i.e. 7 days post patch removal) in animals # 2 and 3 and by evaluation in all three animals on Day 8. 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

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Erythema grade 1 (very slight in degree, barely percetible) were seen in all animals at 1 and 24 hours after patch removal having disappeared in one animal by 48 hours and in the other two animals by 6 days after patch removal. Edema were not evident throughout the 7 days after patch removal. The test sites of two animals were stained brown by the test substance throughout the observation period; this staining did not interfere with the assessment of irritation.

Other effects:

Signs of systemic toxicity or ill health were not evident.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating (EU classification)