Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 03 - 23, 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD TG 429

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
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)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

In vivo test system

Test animals

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: Pre-test: 10-11 weeks; Main test: 9 - 10 weeks
- Weight at study initiation: Pre-test: 22.4 g; Main test: 20.7+/- 1.5 g
- Housing: grouped per dose
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: day 1 To: day 6

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
5, 10, and 25 % (w/w)
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: 50% in MEK
- Irritation: No
- Lymph node proliferation response: -

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: Stimulation index > 3

TREATMENT PREPARATION AND ADMINISTRATION:
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Standard statistical methods have been applied for data processing.

Results and discussion

Positive control results:
Conc. SI
0%: 1.0
5% 1.6
10% 2.4
25% 5.9

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Control: 1 5%: 1.1 10%: 1.5 25% 2.1
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Control: 404.. 5%: 436.8 10%: 604.4 25% 850.8

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
From the data it can be concluded that the test item is not a skin sensitiser under the conditions of this assay.
Executive summary:

Study Design

In the study the test item formulated in MEK was assessed for its possible skin sensitising potential. The GLP study was performed according to OECD TG 429.
For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25% (w/w). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by a pre-experiment.

Results

The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. A statistically significant or biologically relevant increase in ear thickness values was not observed in any of the treatment groups in comparison to the vehicle group. In this study Stimulation Indices (S.I.) of 1.1, 1.5, and 2.1 were determined with the test item at concentrations of 5, 10, and 25% (w/w) in MEK, respectively. A clear dose response was observed.

Conclusion

The test item was not a skin sensitiser under the test conditions of this study.