Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1977-07-17 to 1977-07-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is performed in accordance with US Guidelines, but prior to GLP. As the substance is a cosmetic ingredient no further animal testing should be performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A group of 10 white male guinea-pigs weighing 300-500 g were identified and housed individually. The hair was removed from their backs with an electric clipper prior to initiation of study and whenever necessary throughout the study. They subsisted on commercial rabbit pellets,greens, carrots and water.
A 0.1% solution or suspension of the test material in mazola corn oil was injected intra-cutaneously, using sterile 26-gauge hypodermic needles and sterile tuberculin syringes. The injections were perfomed three times weekly, until a total of ten had been made. These ten sensitising injections were performed at random in the shaved back areas. The eleventh (re-test) injection was made just below the region of the ten sensitising injections. Mazola corn oil was employed as a control and was injected in the same amounts as the test material.
The first injection for each test animal consisted of 0.05 mL, while the remaining none injections consisted of 0.1 mL each. Two weeks after the tenth injection, a challenge (re-test) injection was performed using 0.5 mL of a freshly prepared solution or suspension.
Twenty-four hours after each injection, scores were recorded for the diameter, height and redness of the reactions (if any). A comparison of the reaction following the challenge (re-test) injection was made with the average score for the ten sensitising injections.
GLP compliance:
no
Remarks:
prior to GLP
Type of study:
other: Landsteiner and Jacobs Guinea-pig sensitisation study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The justification for read-across is attached in Section 13 of the IUCLID.

- Name of test material (as cited in study report): Schercemol 1818, Isostearyl Isostearate
- Lot/batch No.: L#121-225

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Details on test animals and environmental conditions:
A group of 10 white male guinea-pigs weighing 300-500 g were identified and housed individually. The hair was removed from their backs with an electric clipper prior to initiation of study and whenever necessary throughout the study. They subsisted on commercial rabbit pellets,greens, carrots and water.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intra-cutaneously
Vehicle:
corn oil
Concentration / amount:
0.1% solution
Challengeopen allclose all
Route:
other: intra-cutaneously
Vehicle:
corn oil
Concentration / amount:
0.1% solution
No. of animals per dose:
10 per test material or control group
Details on study design:
A 0.1% solution or suspension of the test material in mazola corn oil was injected intra-cutaneously, using sterile 26-gauge hypodermic needles and sterile tuberculin syringes. The injections were perfomed three times weekly, until a total of ten had been made. These ten sensitising injections were performed at random in the shaved back areas. The eleventh (re-test) injection was made just below the region of the ten sensitising injections. Mazola corn oil was employed as a control and was injected in the same amounts as the test material.
The first injection for each test animal consisted of 0.05 mL, while the remaining none injections consisted of 0.1 mL each. Two weeks after the tenth injection, a challenge (re-test) injection was performed using 0.5 mL of a freshly prepared solution or suspension.
Twenty-four hours after each injection, scores were recorded for the diameter, height and redness of the reactions (if any). A comparison of the reaction following the challenge (re-test) injection was made with the average score for the ten sensitising injections.
Challenge controls:
Injection with corn oil only
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: re-test after ten sensitising injections
Hours after challenge:
24
Group:
test group
Dose level:
0.1% test solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None stated
Remarks on result:
other: Reading: other: re-test after ten sensitising injections. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1% test solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None stated.
Reading:
other: re-test after ten sensitising injections
Hours after challenge:
24
Group:
negative control
Dose level:
corn oil only
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None stated
Remarks on result:
other: Reading: other: re-test after ten sensitising injections. . Hours after challenge: 24.0. Group: negative control. Dose level: corn oil only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None stated.

Any other information on results incl. tables

No sensitisation responses were recorded after any of the ten sensitising injections or after the challenge (re-test).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material elicited a 0/10 sensitisation rate in a guinea-pig study. The substance is not a skin sensitiser under the conditions of the study.
Executive summary:

Test Guidance

Landsteiner and Jacobs Guinea-pig sensitisation study

Method

A group of 10 white male guinea-pigs weighing 300-500 g were identified and housed individually. The hair was removed from their backs with an electric clipper prior to initiation of study and whenever necessary throughout the study. They subsisted on commercial rabbit pellets,greens, carrots and water.

A 0.1% solution or suspension of the test material in mazola corn oil was injected intra-cutaneously, using sterile 26-gauge hypodermic needles and sterile tuberculin syringes. The injections were perfomed three times weekly, until a total of ten had been made. These ten sensitising injections were performed at random in the shaved back areas. The eleventh (re-test) injection was made just below the region of the ten sensitising injections. Mazola corn oil was employed as a control and was injected in the same amounts as the test material.

The first injection for each test animal consisted of 0.05 mL, while the remaining none injections consisted of 0.1 mL each. Two weeks after the tenth injection, a challenge (re-test) injection was performed using 0.5 mL of a freshly prepared solution or suspension.

Twenty-four hours after each injection, scores were recorded for the diameter, height and redness of the reactions (if any). A comparison of the reaction following the challenge (re-test) injection was made with the average score for the ten sensitising injections.

Results

No sensitisation responses were recorded after any of the ten sensitising injections of a 0.1% solution of the test material in corn oil or after the challenge (re-test) injection. No sensitisation responses were seen in control animals dosed concurrently with the vehicle, corn oil.

Conclusion

The test material elicited a 0/10 sensitisation rate in a guinea-pig study. The substance is not a skin sensitiser under the conditions of the study. In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for skin sensitisation is not required.