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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Evaluation of Skin Irritation and Sensitization of Two Diol Solutions used as Experimental Dentin Primers in Humans and Guinea Pigs.
Author:
Kurihara A, Manabe A, Katsuno K, Itoh K, Hismitsu H, Wakumoto S, Yoshida T
Year:
1996
Bibliographic source:
Dental Materials Journal 15(2): 226-232

Materials and methods

Principles of method if other than guideline:
according to Magnusson and Kligman
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 1996 when the GPMT was an international accepted and recommended method to assess skin sensitizing properties.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: individually, in stainless-steel wire-mesh cages

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2°C
- Humidity (%): 55 ± 5%

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
0.2 % (w/w) and 100 %
Challenge
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
100 %
No. of animals per dose:
4
Details on study design:
This test was performed according to the method of Magnusson and Kligman. A total of 19 guinea pigs were used. For sensitization, the solution for injection was prepared by mixing equal volumes of Freund's complete adjuvant and distilled water using two 5-mL glass syringes and stainless-steel syringe connector. The experimental dentin primers were diluted with olive oil and acetone (7: 3 v/v). Based on the findings of one of our previous papers, the 2-HEMA, HD and EG solutions for this test were diluted with olive oil and acetone at concentrations of 0.2% by weight. In the first stage of induction, 50 µL of each experimental dentin primer solution was intradermally injected into the back skin near the neck. One week later, as the second stage of induction, a filter paper patch soaked in 0.2 mL (100%) of experimental dentin primer was placed onto the shaved back of the guinea pigs. Finally, the experimental dentin primers (100 µL and 100% each) were applied to the skin at two sites using an Eppendorf filter paper under a sealed dressing for induction for 24 hours.

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100 µL
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met