Registration Dossier

Administrative data

Description of key information

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
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Test animal, application of the test chemical, dose level
GLP compliance:
not specified
Test material information:
Composition 1
Species:
guinea pig
Strain:
not specified
Details on test animals 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
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Dose level
GLP compliance:
not specified
Test material information:
Composition 1
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)

Additional information

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.