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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
Study period:
08 Oct 1996 - 21 Jan 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Magnussen and Kligmann Method
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Valid study report available before REACh came into force, therefore no new LLNA test was performed.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: Liquid, yellow
- Analytical purity: 100%
- Lot/batch No.: C96043.01-5
- Expiration date of the lot/batch: 01.01.2006
- Storage condition of test material: at room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HRP inc. and Charles River Laboratories, USA
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 391- 489 g (males); 366 - 480 g (females)
- Housing: individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet: Agway Prolab Purina Guinea Pig Diet; ad libitum
- Water: ad libitum
- Acclimation period: 15 days


ENVIRONMENTAL CONDITIONS
- Temperature and humidity was controlled daily
- Photoperiod (hrs dark / hrs light): 12 / 12 h

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Induction: intradermal injection 5%, epicutaneous application 100%
Challenge: 100%
Challenge
Route:
epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
Induction: intradermal injection 5%, epicutaneous application 100%
Challenge: 100%
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS: Yes (intradermal: October 1st 1996 - October 3rd 1996; topical: October 1st 1996 - October 4th 1996)
2 animals were pre-treated with 2 intradermal injections of FCA/water emulsion (1:1) approx. 1 week prior to test material administration.
0.1 mL of the test substance (5% w/v) solved in propylene glycol was injected on either side of the spinal column and animals were observed for dermal irritation 24 h and 48 h after injection.
For the topical range-finding study, animals (3 per sex) were dosed with 0.1 mL test substance at 4 different concentrations (25%, 50%, 75% and 100% in ethyl alcohol) at different sites, 2 on either side of the column. Substance application occurred for over 24 h under occlusive conditions. Skin reactions were observed 24 and 48 h thereafter.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 1
- Control group: 2 (positive and irritation control)
- Site: A row of three injections was made on each side in the shoulder region.
- Frequency of applications: Days 1 and 8
- Duration: 25 days
- Concentrations: intradermal induction: 5%, topical induction: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 d after last induction application
- Exposure period: 24 h
- Test groups: 1
- Control group: 2 (positive and irritation control)
- Site: Flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches
Positive control substance(s):
yes
Remarks:
Hexylcinnamic aldehyde (HCA)

Results and discussion

Positive control results:
Treatment with 50% HCA resulted in 30% positive response.
Treatment with 100% HCA resulted in 20% positive response (not sensitising, by definition). This lower effect might be due to decreased dermal absorption at high substance concentration.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
Challenge: 100%
No. with + reactions:
1
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
Challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Challenge: 100%
No. with + reactions:
2
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Challenge: 50%
No. with + reactions:
3
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Challenge: 100%
No. with + reactions:
2
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Challenge: 50%
No. with + reactions:
2
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Challenge: 100%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Challenge: 100%
No. with + reactions:
0
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified