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Administrative data

Description of key information

The test item was not sensitizing to skin in an in vivo Local Lymph Node Assay (OECD 429).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jul 01 - Jul 16, 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 20 g
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 5
Vehicle:
methyl ethyl ketone
Concentration:
pre test for signs of irritation: 1, 2.5, 5, and 10 % (v/v)
main test: 2.5, 5, and 10% (v/v)
No. of animals per dose:
pre test: 2
main test: 5 (f) per group (3 test groups, 1 control group) total 20 (f)
Details on study design:
RANGE FINDING TESTS:
To determine the highest non-irritant test concentration, a pre-test was performed in two animals. Two mice were treated with concentrations of 1, 2.5, 5, and 10 % on one ear
each on three consecutive days. Clinical signs were recorded 24 ± 4 hours after each application. At the tested concentrations the animals did not show any signs of irritation or
systemic toxicity.
The test item in the main study was assayed at 2.5, 5, and 10%. The top dose is the highest technically achievable concentration whilst avoiding systemic toxicity and
excessive local irritation. No severe irritant effects were tolerated choosing the test concentrations.

MAIN STUDYANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD TG 429
- Criteria used to consider a positive response: 3-fold greater response at one concentration in SI than control animals

TREATMENT PREPARATION AND ADMINISTRATION:
a) Topical application of 25 µL test item preparation (test group) or vehicle (control group)
b) five days after topical application: iv application of 3H-methyl thymidine
c) prior to each treatment (a and b) ear thickness measurement
d) five hours after treatment (b) necropsy and analysis of the 3H thymidine incorporation in draining lymph nodes
e) method: pooled per animal
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Dunnett's Test
Positive control results:
Conc. SI
5%: 1.78
10% 1.84
25% 4.87
Key result
Parameter:
SI
Value:
0.82
Test group / Remarks:
Test Group 2.5 %
Key result
Parameter:
SI
Value:
0.72
Test group / Remarks:
Test Group: 5 %
Key result
Parameter:
SI
Value:
0.77
Test group / Remarks:
Test Group: 10 %
Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to be not a skin sensitiser under the described conditions in this assay.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, the test is not classified for skin sensitization.