Reaction products of C18 (unsaturated) fatty acids and dimethyl sulfate and triethanolamine

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:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

9-Octadecenoic acid (Z)-, reaction products with triethanolamine, di-Me sulfate-quaternized

EC Number:

302-242-5

EC Name:

9-Octadecenoic acid (Z)-, reaction products with triethanolamine, di-Me sulfate-quaternized

Cas Number:

94095-35-9

Molecular formula:

n.a. (UVCB)

IUPAC Name:

Fatty acids, C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

duration of treatment was 4 hours

Observation period:

reaction was evaluated approx. 30-60 minutes and 24, 48 and 72 hours after the end of exposure period. Additional observations after 6, 9, 13 and 14 days

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: the substance was placed on 2.5 x 2.5 cm squares of hydrophyllic gauze and applied to the corresponding test area. The resulting patches were held close to the body using strips of adhesive tape. Finally, a strip of gauze was wrapped around the trunk of the animal and fixed to the body using additional adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 13 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritant / corrosive response data:

In the readings carried out 24, 48 and 72 hours after administration all of the animals showed erythematic lesions ranging from well defined erythema (grade 2) to marked erythema (grade 3), accompanied by edematic lesions ranging from very slight edema (grade 1) to slight edema (grade 2) and
dryness of the skin.
In the readings carried out on administration days 6, 9 and 13 observed reactions were disappearing in the majority of the animals. Severe dryness of the skin and eschars in the treated areas was observed in nearly all of the animals. At the end of the treatment (day 14), only one animal presented
light eschars in the treated area.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Classification is based on erythema/eschar and oedema calculated as mean scores following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility.
Classification for skin irritation is justified for the oleic acid-based TEA-Esterquat according to CLP, EU GHS (Regulation (EC) No 1272/2008) and
Directive 67/548/EEC.

Executive summary:

In a primary dermal irritation study according to OECD Guideline 404 1992, three New Zealand White rabbits were semi-occlusive dermally exposed to 0.5 mL of the oleic acid-based TEA-Esterquat for 4 hours to approximately 6 cm² of body surface area. Animals then were observed for 14 days. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404.

 

In the readings carried out 24, 48 and 72 hours after administration all of the animals showed erythematic lesions ranging from well defined erythema (grade 2 to marked erythema (grade 3), accompanied by edematic lesions ranging from very slight edema (grade 1) to slight edema (grade 2) and dryness of the skin.

Effects were reversible within the 14 day observation period. In one animal, light eschars were recorded at study termination at day 14.