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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:
07 March 2013 - 21 March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with OECD test 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
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

1
Chemical structure
Reference substance name:
1-butoxy-3-(prop-2-en-1-yloxy)propan-2-ol
EC Number:
801-709-5
Cas Number:
53146-45-5
Molecular formula:
C10H20O3
IUPAC Name:
1-butoxy-3-(prop-2-en-1-yloxy)propan-2-ol
Specific details on test material used for the study:
Description: Brown Liquid
Batch: 12D25
Purity: 94.0%
Expiry Date: 30 January 2014
Storage Conditions: Room temperature in the dark

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK
- Age at study initiation: Eight to twelve weeks old
- Weight at study initiation: 15 to 23 g
- Housing: Animals were randomly allocated to cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five 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): Twelve hours continuous light (06.00 to 18.00) and twelve hours darkness

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
100% (v/v) in acetone/olive oil 4:1
No. of animals per dose:
4
Details on study design:
RANGE FINDING TESTS:
- Lymph node proliferation response: One mouse was treated by daily application of 25 ?L of the undiluted test item to the dorsal surface of each ear
for three consecutive days (Days 1, 2, 3). The mouse was observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6.
A mean ear thickness increase of equal to or greater than 25% was considered to indicate excessive irritation and limited biological relevance to the endpoint of
sensitisation.

MAIN STUDY:
ANIMAL ASSIGNMENT AND TREATMENT: Groups of four mice were treated with the undiluted test item or the test item at concentrations of 50% or 25% v/v in acetone/olive oil 4: 1. The preliminary screening test suggested that the test item would not produce systemic toxicity or excessive local skin irritation at the highest suitable concentration. The mice were treated by daily application of 25 ?L of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3).
- Name of test method: Local Lymph Node Assay.
- 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.

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

Results and discussion

Positive control results:
The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group is as follows:
Concentration (% v/v) in acetone/olive oil (4:1): 25
Stimulation Index: 7.33
Result: Positive

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: vehicle: n/a 25% (v/v): 1.16 50% (v/v): 1.77 100% (v/v): 4.00
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: vehicle: 19354.91 25% (v/v): 22450.71 50% (v/v): 34320.62 100% (v/v): 77510.55

Any other information on results incl. tables

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group

divided by the mean radioactive incorporation of the vehicle control group are as follows:

 Concentration (% v/v) in acetone/olive oil 4:1  Stimulation Index Result 
 25  1.16 Negative
 50  1.77 Negative 
 100  4.00  Positive

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was considered to be a sensitizer under the conditions of the test.

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