Registration Dossier

Administrative data

Description of key information

Read Across: not sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jul 02 - Sep 26, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
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 lymphnode assay (LLNA)
Test material information:
Composition 1
Specific details on test material used for the study:
Batch: E26001046
Appearance: off white, solid
Storage: Jan 31, 2008
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: 7 - 8 weeks
- Weight at study initiation: 19,4 +/- 0,8
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-85%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 5
Vehicle:
acetone/olive oil (4:1 v/v)
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 or the highest technically applicable concentration, a pretest was performed in two mice on three consecutive days. The data of a solubility experiment showed that the highest test item concentration, which
could be technically used was a 10 % solution. At concentrations of 1 and 2.5% the treated mouse did not show any signs of irritation. At concentrations of 5 and 10% the treated mouse showed reddening of the ear skin only after the third application of the test
item. The test item in the main study was, therefore, assayed at 2.5, 5, and 10%.


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 thymidin
c) prior each treatment (a and b) ear thickness measurementd) five hours after treatment (b) necropsy and analysis of the 3H thymidin incorporation in draining lymph nodese) method: pooled per animal
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Dunnets Test
Positive control results:
Conc. SI
5%: 2.43
10% 4.07
25% 4.88
Key result
Parameter:
SI
Value:
1.6
Test group / Remarks:
Test Group 2.5 %
Key result
Parameter:
SI
Value:
2.02
Test group / Remarks:
Test Group: 5 %
Key result
Parameter:
SI
Value:
1.12
Test group / Remarks:
Test Group: 10 %
Interpretation of results:
GHS criteria not met
Conclusions:
From the data it can be concluded that the test item is not a skin sensitiser under the conditions of this assay.
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For this endpoint information from a structural similar compound, 1-Ethoxy-2,3-difluoro-4-[trans-4-(trans-4-propylcyclohexyl)-cyclohexyl]-benzene, is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 429. See chapter 13 report for a more detailed justification.
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Key result
Parameter:
SI
Value:
1.6
Test group / Remarks:
Test Group 2.5%
Key result
Parameter:
SI
Value:
2.02
Test group / Remarks:
Test Group 5%
Key result
Parameter:
SI
Value:
1.12
Test group / Remarks:
Test Group 10%
Interpretation of results:
GHS criteria not met
Conclusions:
Read Across: not sensitising
Executive summary:

For this endpoint information from a structural similar compound, 1-Ethoxy-2,3-difluoro-4-[trans-4-(trans-4-propylcyclohexyl)-cyclohexyl]-benzene, is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 429. See chapter 13 report for a more detailed justification.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 429. See chapter 13 report for a more detailed justification.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the provided information there is no need to classified according to the EU Regulation (EC) No 1272/2008 on Classification,Labelling and Packaging of Substances and Mixtures.