Registration Dossier

Administrative data

Description of key information

Ski sensitisation:

The test item was considered to be a non-sensitizer under the conditions of the test.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 November 2015 to 08 December 2015
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:
No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
Batch: L002
Purity: 95.4%
Physical state/Appearance: pale yellow liquid
Expiry Date: 15 August 2016
Storage Conditions: room temperature in the dark
Species:
mouse
Strain:
CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 15 to 23 g
- Housing: suspended solid floor polypropylene cages furnished with softwood woodflakes
- Diet (e.g. ad libitum): Free access to food
- Water (e.g. ad libitum): Free access to mains tap water
- Acclimation: period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25%, 10% or 5% v/v in acetone/olive oil 4:1
No. of animals per dose:
4
Details on study design:
PRE-SCREEN TESTS:
- Irritation: measured
- Systemic toxicity: measured
- Ear thickness measurements: measured
- Erythema scores: measured

MAIN STUDY

ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Pooled Method
- Criteria used to consider a positive response: The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values.

TREATMENT PREPARATION AND ADMINISTRATION:
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Positive control results:
Concentration (% v/v) in
acetone/olive oil 4:1 Stimulation Index Result
25 6.08 Positive

α Hexylcinnamaldehyde, tech., 85% was considered to be a sensitizer under the conditions of the test.
Key result
Parameter:
SI
Value:
1.69
Test group / Remarks:
Concentration in acetone/olive oil 4:1: 5 % v/v
Key result
Parameter:
SI
Value:
2.61
Test group / Remarks:
Concentration in acetone/olive oil 4:1: 10 % v/v
Key result
Parameter:
SI
Value:
2.84
Test group / Remarks:
Concentration in acetone/olive oil 4:1: 25 % v/v
Cellular proliferation data / Observations:
See Table 1.

Table 1       Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index

Concentration (% v/v) in acetone/olive oil 4:1 dpm dpm/Node a Stimulation Index b Result
Vehicle 15046.38 1880.80 na na
5 25366.65 3170.83 1.69 Negative
10 39210.85 4901.36 2.61 Negative
25 42781.98 5347.75 2.84 Negative

dpm =       Disintegrations per minute

a =       Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)

b =              Stimulation Index of 3.0 or greater indicates a positive result

na  =              Not applicable

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was considered to be a non-sensitizer under the conditions of the test.

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

The test item failed to produce a threefold or greater increase in 3HTdR incorporation. It was classified as a non sensitizer under the conditions of the test, according to the criteria in CLP Annex I, Table 3.4.3 to 3.4.4, there is no classification.