2-lauroyloxyethyltrimethylammonium chloride

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November / December 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Test animal, application of the test chemical, dose level

GLP compliance:

not specified

Species:

guinea pig

Strain:

not specified

Details on test animals or test system and environmental conditions:

Housing and feeding conditions:
The temperature of the experimental animal room was 20°C. The relative humidity was 50%. Lighting was artificial, the sequence was 12 hours light, 12 hours dark. Food and water was provided at discretion.

Type of coverage:

open

Preparation of test site:

shaved

Vehicle:

other: vaseline

Controls:

not specified

Amount / concentration applied:

200 ppm

Duration of treatment / exposure:

7 d

Observation period:

daily

Number of animals:

12

Irritation parameter:

erythema score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

After daily application of the test substance 2-lauroyloxyethyltrimethylammonium chloride in vaseline no skin irritation could be observed, after one week. The test substance can be stated as non-irritating.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November / December 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

DRAIZE test

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Dose level

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Housing and feeding conditions:
The temperature of the experimental animal room was 20°C. The relative humidity was 50%. Lighting was artificial, the sequence was 12 hours light, 12 hours dark. Food and water was provided at discretion.

Vehicle:

physiological saline

Controls:

yes, concurrent negative control

Amount / concentration applied:

physiological saline with 2000 ppm of the test substance 2-lauroyloxyethyltrimethylammonium chloride

Duration of treatment / exposure:

4 d

Observation period (in vivo):

daily

Number of animals or in vitro replicates:

8

Details on study design:

One minute after application the treated eye was rinsed with 10-20 mL of lukewarm physiological saline, at one half of the test animals (4 animals).

Irritation parameter:

cornea opacity score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Remarks:

even after 96h

Irritation parameter:

iris score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Remarks:

even after 96h

Irritation parameter:

conjunctivae score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Remarks:

even after 96h

Irritation parameter:

chemosis score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Remarks:

even after 96h

Interpretation of results:

GHS criteria not met

Conclusions:

After daily application of the test substance 2-lauroyloxyethyltrimethylammonium chloride in physiological saline no eye irritation could be observed, after overall 4 days. The test substance can be stated as non-irritating for the eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

The results of the above mentioned key studies for skin and eye irritation showed, that after 7 days no signs of erythema or oedema and after 4 days no signs of eye irritation/corrosion could be observed. According to Annex I in regulation (EC) No 1272/2008 of the european parliament and of the council, the test substance 2-lauroyloxyethyltrimethylammonium chloride is not classified as irritating or corrosive to the skin or the eyes.