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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study with detailed documentation, in accordance with GLP standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
For several hours relative humidity in the animal room was 45 - 100% and the temperature was 20 - 26°C.
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
For several hours relative humidity in the animal room was 45 - 100% and the temperature was 20 - 26°C.
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
MAEEBP 4-methacryloyl diethoxy benzophenone
IUPAC Name:
MAEEBP 4-methacryloyl diethoxy benzophenone
Details on test material:
- Name of test material (as cited in study report): MAEEBP- Physical state: Colourless liquid- Analytical purity: 85 area%- Lot/batch No.: 150301- Expiration date of the lot/batch: 01 September 2015- Storage condition of test material: At +2 to +8 °C, light protected, moisture protected

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Strain: Mice, CBA/CaOlaHsd- Source: Envigo RMS B.V. Inc., The Netherlands- Age at study initiation: Pre-test and main study: 9 - 10 weeks- Housing: group- Diet (e.g. ad libitum): 2018C Teklad Global 18% protein rodent diet (certified), ad libitum- Water (e.g. ad libitum): tap water, ad libitumENVIRONMENTAL CONDITIONS- Temperature (°C): 22 + 2°C. The temperature was between 20 and 26°C instead of 20 and 24°C for several hours, due to insufficient capacity of the air conditioning system during a summer heat wave.- Humidity (%): 45-65%. The relative humidity in the animal room was between approximately 45 - 100% instead of 45 – 65% for several hours, due to insufficient capacity of the air conditioning system during a summer heat wave.- Photoperiod (light): 6.00 a.m. - 6.00 p.m.

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
pre-test: 25 and 50%main test: 5, 10, and 25% (w/v)
No. of animals per dose:
Pre-test: 2 femalesMain study: 4 females per dose
Details on study design:
RANGE FINDING TESTS:- Compound solubility: highest test item concentration, which can be technically used was a 50% solution in acetone/olive oil (4+1, v/v).
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
The mean values and standard deviations were calculated in the body weight tables.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: See: Any other information on results, Table 1
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: See: Any other information on results, Table 1

Any other information on results incl. tables

 Table 1. Results on Disintegration per minute (DPM) and Stimulation index (S.I.)

Test item concentration %

Group

Measurement DPM

Calculation

Result

DPM-BG

number of lymph nodes

DPM per lymph node

S.I.

-

BG I

21

-

-

-

-

-

BG II

26

-

-

-

-

0

1

5964

5940.5

8

742.6

1.00

10

2

12750

12726.5

8

1590.8

2.14

25

3

12461

12437.5

8

1554.7

2.09

50

4

18586

18562.5

8

2320.3

3.12

 

EC3: 47.1% (w/w)

No deaths occurred during the study period.

On day 3, the animals treated with a test item concentration of 50% showed increased spontaneous activity and an erythema of the ear skin (Score 1) as well as on the scalp. Animals treated with 10 and 25% test item concentration did not show any signs of local skin irritation.

The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The test item MAEEBP was found to be a skin sensitiser at a tested concentration of 50%. An EC3 value of 47.1 % (w/w) was derived.
Executive summary:

In the study the test item MAEEBP formulated in acetone/olive oil (4+1, v/v) was assessed for its possible skin sensitising potential.

For this purpose a local lymph node assay was performed using test item concentrations of 10, 25, and 50% (w/w).

Cases of mortality were not observed. On day 3, the animals treated with a test item concentration of 50% showed increased spontaneous activity and an erythema of the ear skin (Score 1) as well as on the scalp. Animals treated with 10 and 25% test item concentration did not show any signs of toxicity nor local skin irritation.

The deviations in relative humidity and temperature do not affect the validity of the study.

In this study Stimulation Indices (S.I.) of 2.14, 2.09, and 3.12 were determined with the test item at concentrations of 10, 25, and 50% (w/w) in acetone/olive oil (4+1, v/v), respectively.

The test item MAEEBP was found to be a skin sensitiser at a tested concentration of 50%. An EC3 value of 47.1 % (w/w) was derived.

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