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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study already available

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Ibm: GOHI; SPF-quality (Himalayan spotted).
Sex:
female
Details on test animals and environmental conditions:
Source RCC Ltd, Biotechnology & Animal Breeding Division, Switzerland
Age/weight at study initiation
Age at pretest start/beginning of acclimatization period: 4 - 6 weeks.
Body weight of pretest groups at start of pretest: 335 to 379 g.
Body weight of control and test group at beginning of acclimatization period: 356 to 410 g.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: Freund’s Adjuvant – Complete
Concentration / amount:
Intradermal induction: 5% in purified water and FCA:physiological saline. Epidermal induction: 50% in purified water.
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
25% in purified water.
Day(s)/duration:
Day 22 (2 weeks after epidermal induction).
No. of animals per dose:
Intradermal Pretest: 1 female.
Epidermal Pretest: 2 females.
Control Group in Main Study: 5 females.
Test Group in Main Study: 10 females.
Details on study design:
Rechallenge: Not performed.
Scoring schedule: 24 and 48 h after challenge
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
Total no. in group:
5
Remarks on result:
other: result not stated
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
other: result not stated

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Ten female Himalayan spotted guinea pigs each received intradermal applications of 5% MERGAL V615 in both purified water and in a 1:1 (v/v) mixture of FCA: physiological saline, followed a week later by an epidermal application of 50% MERGAL V615 in purified water (occlusive) during the induction period. Two weeks after the epidermal induction, the animals received a topical application of the test article (25% in purified water), which was the previously determined maximum non-irritating concentration of the test article. Twenty-one hours after removal of the dressing, treated sites were depilated as described previously. Five guinea pigs served as controls that received the intradermal and epidermal inductions without the test agent. Two weeks after induction, the control animals received challenge applications of purified water and 25% MERGAL V615 in purified water. All animals were observed for erythema and oedema at 24 and 48 hours after removal of the occlusive dressings.