Registration Dossier

Administrative data

Description of key information

Skin sensitisation, LLNA - Not sensitising

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:
11 February 2015 - 17 February 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)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
Appearance: Blue powder
Purity: ≥85.5%
Storage conditions: Controlled Room Temperature (15-25oC, below 70 RH%)
Species:
mouse
Strain:
other: CBA/CaOlaHsd mice
Remarks:
CBA/CaOlaHsd mice
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 12 weeks old (age-matched, within one week)
- Weight at study initiation: 19.0-21.3 g (the weight variation in animals in the study did not exceed ± 20% of the mean weight)
- Housing: Group caging / mice were provided with glass tunnel-tubes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7-24.8°C
- Humidity (%): 31-69 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Vehicle:
dimethyl sulphoxide
Concentration:
not specified
No. of animals per dose:
4
Details on study design:
PRE-SCREEN TESTS:
- Compound solubility: in DMSO
- Irritation: test item concentrations of 5 and 2.5% (w/v) in DMSO
- Systemic toxicity: none observed
- Ear thickness measurements: yes
- Erythema scores: 0

- Criteria used to consider a positive response: - That exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index.
- 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: Freshly prepared in DMSO
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
not specified
Positive control results:
Larger than normal lymph nodes were observed in the positive control group. Stimulation index = 6.6
A significant lymphoproliferative response (stimulation index value of 6.6) was noted for HCA in the main experiment. This value was considered to confirm the appropriate performance of the assay
Key result
Parameter:
SI
Value:
ca. 0.9
Test group / Remarks:
B331 (0.5% (w/v) in DMSO)
Key result
Parameter:
SI
Value:
ca. 0.9
Test group / Remarks:
B331 (1 % (w/v) in DMSO)
Key result
Parameter:
SI
Value:
ca. 1.2
Test group / Remarks:
B331 (2.5% (w/v) in DMSO)
Key result
Parameter:
SI
Value:
ca. 1.3
Test group / Remarks:
B331 (5 % (w/v) in DMSO)
Cellular proliferation data / Observations:
CELLULAR PROLIFERATION DATA : The appearance of the lymph nodes was normal in the negative (vehicle) control group and in all test item treated group. Larger than normal lymph nodes were observed in the positive control group (subjective judgement by analogy with observations of former experiments

CLINICAL OBSERVATIONS: No mortality or signs of systemic toxicity. no indications of any irritancy at the site of application

BODY WEIGHTS: No treatment related effects were observed on body weights
Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, under the conditions of the present assay, B331, tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node 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

B331 was determined not to be a skin sensitiser (LLNA). On this basis it is concluded that B331 does not meet the criteria as a skin sensitiser in accordance with Regulation (EC) 1272/2008.

No data are available with respect to respiratory sensitisation, but as the substance has been found not to induce skin sensitisation it is considered that the available data does not indicate any concern for a respiratory sensitising effect.