Registration Dossier

Administrative data

Description of key information

For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 429.

The source compound showed an SI values below 3 and thus no potential for skin sensitisation. A detailed read across justification is provided in chapter 13 of this dossier.  

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:
Apr 03 - May 02, 2013
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:
other: CBA/CaOlaHsd
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories B.V. Postbus 6174 5960 AD Horst / The Netherlands
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: -
- Age at study initiation: 9-10 weeks
- Weight at study initiation: (21.5 +/- 1.1) g
- Housing: group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
- Indication of any skin lesions:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 45 - 65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
10, 25, and 50% (w/w)
No. of animals per dose:
5
Details on study design:
According to guideline
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
one-way ANOVA
Positive control results:
5% SI=1.6
10% SI=2.4
25% SI=5.9
Key result
Parameter:
SI
Value:
1.6
Test group / Remarks:
10% Test group
Key result
Parameter:
SI
Value:
1.7
Test group / Remarks:
25% Test group
Key result
Parameter:
SI
Value:
1.3
Test group / Remarks:
50% Test group
Cellular proliferation data / Observations:
CELLULAR PROLIFERATION DATA

DETAILS ON STIMULATION INDEX CALCULATION

Group DPM SI
BG: 290.9 1.0
10% 508.9 1.8
25% 484.9 1.7
50% 378.5 1.3

EC3 CALCULATION
No EC3 calculation as all SIs are below 3.

CLINICAL OBSERVATIONS:
No deaths occurred during the study period.
No symptoms of local skin irritation at the ears of the animals and no signs of systemic toxicity were observed during the study period.

BODY WEIGHTS
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
Interpretation of results:
GHS criteria not met
Conclusions:
The test material was not a skin sensitiser under the test conditions of this study.
Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 429. The test material was not a skin sensitiser under the test conditions of this study.

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 429. A detailed read across justification is provided in chapter 13 of this dossier.
Reason / purpose:
read-across source
Key result
Parameter:
SI
Value:
1.8
Test group / Remarks:
test group 10 %
Key result
Parameter:
SI
Value:
1.7
Test group / Remarks:
test group 25 %
Key result
Parameter:
SI
Value:
1.3
Test group / Remarks:
test group 50 %
Interpretation of results:
GHS criteria not met
Conclusions:
For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 429.
The source compound showed an SI values below 3 and thus no potential for skin sensitisation. A detailed read across justification is provided in chapter 13 of this dossier.
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)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

This endpoint was filled by read across. The source study was performed according to GLP and the methods applied are fully compliant with OECD TG 429. No adverse events have been determined. Thus, the test item is not classified for skin sensitization according to Regulation (EC) No 1272/2008.