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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:
11 April 2013 to 08 May 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to OECD and EEC guidelines and in compliance with GLP

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate of compliance from UK GLP Monitoring Authority
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MTF
- Substance type: Organic
- Physical state: Transparent Liquid
- Analytical purity: ca. 100%
- Lot/batch No.: M1204
- Expiration date of the lot/batch: 31 December 2015
- Storage condition of test material: room temperature (20 deg C) under nitrogen
- Other:

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 18.3 - 21.8 g
- Housing: 2 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 60 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 deg C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 17 April 2013 To: 07 May 2013

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
10, 25 and 50% v/v
No. of animals per dose:
2 per dose
Details on study design:
Preliminary investigation:
Two female mice (per concentration) received a daily application of 25 µL of appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3). The test substance was applied to the dorsal surface of each ear using an automatic micropipette and was spread
over the entire dorsal surface of the ear using the tip of the pipette.

Main phase
Groups of four mice were treated at one of three concentrations of the test substance. The mice were treated by daily application of 25 µL of the appropriate
concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3). The test was applied to the dorsal surface of each ear using an automatic micropipette and was spread over the entire dorsal surface of the ear using the tip of the pipette. Further groups of four mice received the vehicle alone or the positive control substance in the same manner.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
The SI for the positive control substance hexyl cinnamic aldehyde (HCA) was 6.5 which demonstrates the validity of this study.

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
3.8
Test group / Remarks:
10%
Key result
Parameter:
SI
Value:
7.8
Test group / Remarks:
25%
Key result
Parameter:
SI
Value:
7.3
Test group / Remarks:
50%
Key result
Parameter:
EC3
Value:
8.7
Remarks on result:
positive indication of skin sensitisation based on QSAR/QSPR prediction

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
MTF is regarded as a potential skin sensitizer. The EC3ex value was calculated to be 8.3 % v/v.