Registration Dossier

Administrative data

Description of key information

Propanoic acid, 2-hydroxy, C12-C16 (even numbered) alkyl esters (15% solution) was not a sensitizer to guinea pig skin. Ten white male guinea pigs were treated using intracutaneous injections of 0.1% Propanoic acid, 2-hydroxy, C12-C16 (even numbered) alkyl esters (15% active) three times a week for a total of ten injections. The first injection was 0.5 ml and the remaining injections were 0.1 ml. Sterile saline was used as the control and the same amounts as test material were injected. Two weeks following the tenth injection, all animals were challenged with 0.05 ml Propanoic acid, 2-hydroxy, C12-C16 (even numbered) alkyl esters (15% solution) on a virgin site. The test sites were scored 24 hours after each injection. No dermal reactions were exhibited during either the induction phase or challenge phase of the study.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 February - 8 April 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is non-GLP, but well described except for ommissions in experimental conditions like temperature and humidity.
Principles of method if other than guideline:
Landsteiner and Jacobs Guina pig sensitization procedure. The method included ten sensitizing injections (three times weekly) followed by an eleventh (re-test) injection.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Result are from a study performed in 1976, i.e. before the LLNA requirement.
Species:
guinea pig
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
Body weights: 300-500 grams.
Cages: Commercial rabbit pellets and fed with greens, carrots and water.
No further data on test conditions.
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1%
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1%
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
Injections were performed three times weekly until a total of ten had been applied. The first injection contained 0.05 ml, while the other nine were each 0.1 ml. An eleventh injection was applied as challenge below the area of the ten sensitization injections. Twenty-four hours after each injection, scorings were performed for the diameter, height and redness of the reactions. A comparison of the reaction following the challenge injection was made with the average score for the sensitizing injections. Substantial increase in response after challenging indicates a possible significant sensitization.
Challenge controls:
0.1 % corn oil in physiological saline was employed as a control.
Positive control substance(s):
no
Reading:
other: average of ten sensitizing injections
Group:
test group
Dose level:
0.1% solution
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Reading:
other: reading after eleventh injection
Hours after challenge:
24
Group:
test group
Dose level:
0.1% solution
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Reading:
other: average of ten sensitizing injections
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Reading:
other: reading after eleventh injection
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other:
Conclusions:
On the challenge injection, none of the test animals exhibited reactions higher than the average of the original scores. Although the test method is not equivalent to the method described in international guidelines, the total lack of response indicates that the test material is not sensitizing.
Executive summary:

Propanoic acid, 2-hydroxy, C12-C16 (even numbered) alkyl esters (15% solution) was not a sensitizer to guinea pig skin. Ten white male guinea pigs were treated using intracutaneous injections of 0.1% Propanoic acid, 2-hydroxy, C12-C16 (even numbered) alkyl esters (15% active) three times a week for a total of ten injections. The first injection was 0.5 ml and the remaining injections were 0.1 ml. Sterile saline was used as the control and the same amounts as test material were injected. Two weeks following the tenth injection, all animals were challenged with 0.05 ml Propanoic acid, 2-hydroxy, C12-C16 (even numbered) alkyl esters (15% solution) on a virgin site. The test sites were scored 24 hours after each injection. No dermal reactions were exhibited during either the induction phase or challenge phase of the study.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
26 February - 8 April 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is non-GLP, but well described except for ommissions in experimental conditions like temperature and humidity.
Justification for type of information:
See section 13 for justification of read across.
Principles of method if other than guideline:
Landsteiner and Jacobs Guina pig sensitization procedure. The method included ten sensitizing injections (three times weekly) followed by an eleventh (re-test) injection.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study has been performed before the LLNA method was available.
Species:
guinea pig
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
Body weights: 300-500 grams.
Cages: Commercial rabbit pellets and fed with greens, carrots and water.
No further data on test conditions.
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1%
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1%
No. of animals per dose:
10
Details on study design:
Injections were performed three times weekly until a total of ten had been applied. The first injection contained 0.05 ml, while the other nine were each 0.1 ml. An eleventh injection was applied as challenge below the area of the ten sensitization injections. Twenty-four hours after each injection, scorings were performed for the diameter, height and redness of the reactions. A comparison of the reaction following the challenge injection was made with the average score for the sensitizing injections. Substantial increase in response after challenging indicates a possible significant sensitization.
Challenge controls:
0.1 % corn oil in physiological saline was employed as a control.
Positive control substance(s):
no
Reading:
other: average of ten sensitizing injections
Group:
test group
Dose level:
0.1% solution
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
one animal with a score of 0.1
Remarks on result:
other: Reading:
Reading:
other: reading after eleventh injection
Hours after challenge:
24
Group:
test group
Dose level:
0.1% solution
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Reading:
other: average of ten sensitizing injections
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Reading:
other: reading after eleventh injection
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
On the challenge injection, none of the test animals exhibited reactions higher than the average of the original scores. Although the test method is not equivalent to the method described in international guidelines, the total lack of response indicates that the test material is not sensitizing.
Executive summary:

CERAPHYL® 41 (15% active) was not a sensitizer to guinea pig skin. Ten white male guinea pigs were treated using intracutaneous injections of 0.1% CERAPHYL® 41 (15% active) three times a week for a total of ten injections. The first injection was 0.5 ml and the remaining injections were 0.1 ml. Sterile saline was used as the control and the same amounts as test material were injected. Two weeks following the tenth injection, all animals were challenged with 0.05 ml CERAPHYL® 41 on a virgin site. The test sites were scored 24 hours after each injection. No dermal reactions were exhibited during either the induction phase or challenge phase of the study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Lauryl lactate was not a sensitizer to guinea pig skin. High molecular lactate esters appear to be non-sensitizers.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Conclusively, lauryl lactate is not a skin sensitizer and is not classified as such. Due to a lack of data, no conclusive decision can be made regarding respiratory sensitization.