Fatty acids, C16-18, reaction products with triethanolamine, di-Me sulfate-quaternized

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-01-29 to 2002-02-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

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:

Fatty acids, C16-18(even numbered), reaction products with triethanolamine, di-Me sulfate-quaternized

Cas Number:

91032-11-0

Molecular formula:

n.a. (UVCB)

IUPAC Name:

Fatty acids, C16-18(even numbered), 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:

other: unchanged, moistened in 0.3 mL deionized water

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution):0.5 g fully saturated TEA-EQ, hardened moistened in 0.3 mL deionized water

Duration of treatment / exposure:

the 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

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: the substance was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster, the plaster was fixed to the skin area and then covered with a semi-occlusive bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm tap water
- Time after start of exposure:after the exposure period


SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No signs of irrtations were observed during the study.

Other effects:

No clinical signs of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

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.
No classification for skin irritation is justified for fully saturated TEA-Esterquat according to CLP, EU GHS (Regulation (EC) No 1272/2008).

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 g of the “fully saturated TEA-Esterquat” for 4 hours to approximately 6 cm² of body surface area. Animals then were observed for 72 hours. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404.

No signs of irritation occurred during the whole observation period. No clinical signs of systemic toxicity were observed.