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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 18 - October 10, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
adopted 22 July 2010
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
updated 06 July 2012
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS B.V., Inc Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: Pre-test and main study: 10 - 11 weeks
- Weight at study initiation: Pre-test: 21.0 and 21.7 g; Main test: 17.7 - 22.9 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 5

Study design: in vivo (LLNA)

Vehicle:
methyl ethyl ketone
Concentration:
10, 25, and 50%. (w/w)
No. of animals per dose:
4
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: 25 and 50 % in Methyl Ethyl Ketone
- Irritation: 50%: very slight erythema of the ear skin (Score 1) and scaly ears on day 6, 25%: very slight erythema of the ear skin (Score 1) on day 4
- Systemic toxicity: no signs of systemic toxicity
- Ear thickness measurements: No excessive increase in ear thickness or ear weights was recorded in the animals

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

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
Conc. SI
10% 0.84
25% 1.35
50% 0.94

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
0.84
Test group / Remarks:
Test Group: 10 %
Key result
Parameter:
SI
Value:
1.35
Test group / Remarks:
Test Group: 25 %
Key result
Parameter:
SI
Value:
0.94
Test group / Remarks:
Test Group: 50 %

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was not a skin sensitiser under the test conditions of this study.
Executive summary:

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