2-Propenoic acid, 2-methyl-, 2-[2-(4-benzoylphenoxy)ethoxy]ethyl ester

Skin sensitisation

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 guideline

Test guideline 1

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.

Test guideline 2

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

Test material information

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)

Results

Results 1

Parameter:

SI

Remarks on result:

other: See: Any other information on results, Table 1

Results 2

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.