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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:
2002-01-29 to 2002-03-08
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)
Version / remarks:
July 17, 1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
July 30, 1996
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
This study was conducted due to non-REACH regulatory requirements. With the existing data from this study not only being acceptable but of good quality, this study precludes the need for an additional LLNA study. In addition, a supplementary LLNA study would violate the ECHA objectives with regards to animal welfare.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Praepagen T gehaertet
- Physical state: white wax
- Lot/batch No.: GC 01/198
- Expiration date of the lot/batch: Dec-2002
- Stability and homogeneity in the vehicle: is guaranted for 4 h in deinonized water by the sponsor:
- Storage condition of test material: at approx. 20 °C in a fume cupbord

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Mol:DH (Moellegaard)
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M & B A/S, P.O. bos 1079, 8680 Ry, Denmark
- Age at study initiation: no data
- Weight at study initiation: mean: 366 g
- Housing: individually in transparent macrolon cages (type V) on soft wood granulate in an air-conditioned room, 5 animals per cage
- Diet: ad libitum, ssniff Ms-H (V 2233)
- Water: ad libitum, tap water in plastic bottles
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 100 % in deionized water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Challenge: 100 % in deionized water
No. of animals per dose:
3 - preliminary study
10 – main study control
20 – main study treatment
Details on study design:
PRELIMINARY STUDY AND DOSE RANGE FINDING
Left flank: 20 % (in deinonized water), 100% (moistened)
Right flank: 4, 20% (in deinonized water)
Topical application 0.5 g of test substance moistened with 0.5 ml deionized water per plaster (4 cm2) for 6h under fully occluded conditions

INDUCTION
100% (non-irritating)
Topical application 0.5 g of test substance moistened with 0.5 ml deionized water per plaster (4 cm2) for 6h under fully occluded conditions, three times at intervals of one week. Skin grading 24 and 48h following patch removal

CHALLENGE
100% (non-irritating); 14 days after the last induction exposure, application of the challenge patch on the shaved skin for 6h; skin evaluations 24 and 48h after patch removal

GRADING SYSTEM
Dermal reactions graded for erythema and edema by blind reading according to grading scale:
- No visible change: 0
- Discrete or patchy erythema: 1
- Moderated and confluent erythema: 2
- Intense erythema and swelling: 3
Positive control substance(s):
yes
Remarks:
Alpha-hexylcinnamic aldehyde

Results and discussion

Positive control results:
The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the Buehler test. No unforeseen circumstances were observed which might have affected the quality or integrity of the study.

In vivo (non-LLNA)

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

Any other information on results incl. tables

PRELIMINARY STUDY AND DOSE RANGE FINDING

No irritation at any dose. Concentration for induction and challenge: 100%

MAIN STUDY

No skin reaction observed in the control and test animals treated at the test item at 100% in de‐ionized water.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met