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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:
2012-12-05 to 2013-04-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
17 July 1992
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Version / remarks:
March 2003
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
PHYCHER BIO Developpement - ZA de Toctoucau - 18, chemin de Lou Tribail - 33610 CESTAS Cedex, France
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 (Klimisch Score 1), 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
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: COD-001701
- Expiration date of the lot/batch: 2014-11-01
- Purity test date: 2012-10-24

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (or cooler)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (69592 L’Arbresle, France)
- Age at study initiation: 5 weeks
- Weight at study initiation: between 301 g and 362 g
- Housing: The animals were housed in groups of 2 in polycarbonate containers. The flooring of the cages was covered with dust-free wood shavings and the top fitted a stainless steel lid containing with a feeding device and drinking device.
- Diet: SAFE, 106 ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

- IN-LIFE DATES: From: 2012-12-08 To: 2013-01-31

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: liquid paraffin
Concentration / amount:
60%
Day(s)/duration:
Day 0, Day 6, Day 13/6 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: liquid paraffin
Concentration / amount:
60%
Day(s)/duration:
28 / 6 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
treatment group: 20 animals
Details on study design:
RANGE FINDING TESTS: This test was carried out with a reduced animal’s number, for the purpose of determining the maximal item concentrations without risk of an irritant effect during the challenge phase. The animals treated at the concentrations of 60%, 40%, 20% and 10% received 0.5 g of the corresponding preparation.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Test groups: 1
- Control group: 1
- Site: inter-scapular zone
- Frequency of applications: Day 0, Day 6, Day 13
- Concentration: 60% in liquid paraffin

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2
- Exposure period: 6 h
- Test groups: 1
- Site:dorso-lumbar zone
- Concentration: 60% in liquid paraffin
- Evaluation (hr after challenge): 24 + 48 after removal of the occlusive dressing
Challenge controls:
negative control group: 10 animals
Positive control substance(s):
yes
Remarks:
alpha-Hexylcinnamaldehyde (CAS 101-86-0)

Results and discussion

Positive control results:
Up to 100% of the animals per group were sensitised.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
60%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
60%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met