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Description of key information

A study according to OECD TG 429 was performed with a structural analogue substance on guinea-pigs. No skin sensitization was reported (reference 7.4.1 -1).

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:
2003-07-11 to 2003-10-13
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)
Version / remarks:
adopted 24 April 2002
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: 17.6 - 25.0 g
- Housing: groups of 4
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified

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:
acetone/olive oil (4:1 v/v)
Concentration:
pre-test for irritation: 1, 2.5, 5 and 10 % (w/v)
main test: 2.5, 5 and 10 % (w/v)
No. of animals per dose:
pre test: 2
main test: 4 (f) per group (3 test groups, 1 control group) total 16 (f)
Details on study design:
RANGE FINDING TESTS:
In a non-GLP conform pre-test in two mice, test item concentrations of 1 %, 2.5 %, 5 % and 10 % (w/v) were tested on one ear each. No irritation effects were observed at these concentrations after a single application. 10 % (w/v) was the highest technically achievable concentration in the chosen vehicle.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD TG 429
- Criteria used to consider a positive response: A test item is regarded as a sensitizer in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.

TREATMENT PREPARATION AND ADMINISTRATION:
- Topical application of 25 µL test item preparation (test group) or vehicle (control group)
- five days after topical application: iv application of 3H-methyl thymidine
- five hours after treatment with 3H-methyl thymidine, necropsy and analysis of the 3H thymidine incorporation in draining lymph nodes
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Dunnets Test
Positive control results:
alpha-hexylcinnamaldehyde:
5% : S.I=1.5
10%: S.I.=3.2
25%: S.I.=6.9
Key result
Parameter:
SI
Value:
2
Test group / Remarks:
Test Group 2.5 %
Key result
Parameter:
SI
Value:
2.3
Test group / Remarks:
Test Group: 5 %
Key result
Parameter:
SI
Value:
2
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.
Executive summary:

A LLNA study according to OECD 429 was performed in order to study a possible contact allergenic potential of the test material, three groups each of four female mice were treated daily with the test item at concentrations of 2.5, 5 and 10 % (w/v) in acetone:olive oil, 4:1 (v/v) by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. 10 % was the highest technically achievable concentration in the vehicle.

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 2., 2.3 and 2.0 were determined with the test item at concentrations of 2.5, 5, and 10 % in acetone:olive oil, 4:1 (v/v), respectively.

The test material was found to be not a skin sensitiser up to the highest technically achievable concentration of 10 % in the selected vehicle.

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 structural similar compounds is available. The studies for these similar compounds were 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
Key result
Parameter:
SI
Value:
2
Test group / Remarks:
Test group 2.5 %
Key result
Parameter:
SI
Value:
2.3
Test group / Remarks:
Test group 5 %
Key result
Parameter:
SI
Value:
2
Test group / Remarks:
Test group 10 %
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 conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A LLNA study according to OECD 429 was performed with the structural analogue substance in order to study a possible contact allergenic potential of the test material, three groups each of four female mice were treated daily with the test item at concentrations of 2.5, 5 and 10 % (w/v) in acetone:olive oil, 4:1 (v/v) by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. 10 % was the highest technically achievable concentration in the vehicle.

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 2., 2.3 and 2.0 were determined with the test item at concentrations of 2.5, 5, and 10 % in acetone:olive oil, 4:1 (v/v), respectively.

The test material was found to be not a skin sensitiser up to the highest technically achievable concentration of 10 % in the selected vehicle.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this information, the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.