Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
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: other: average of ten sensitizing injections. Group: test group. Dose level: 0.1% solution. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: one animal with a score of 0.1.
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: other: reading after eleventh injection. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1% solution. No with. + reactions: 0.0. Total no. in groups: 10.0.
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: other: average of ten sensitizing injections. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
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: other: reading after eleventh injection. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: No readings reported
Group:
positive control
Remarks on result:
not measured/tested
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:

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. Two weeks following the tenth injection, all animals were challenged with 0.05 ml CERAPHYL® 41 on a virgin site. 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.


Justification for selection of skin sensitisation endpoint:
Key study with Ceraphyl 41.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Conclusively, CERAPHYL® 41 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.