[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well documented giudeline study under GLP

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

yes

Remarks:

rel. humidity was between 65 - 95% during pretest for several hours. However it does not affect the validity of the study

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EU Method B.42(Skin Sensitisation: Local Lymph Node Assay)

Deviations:

yes

Remarks:

see above

Principles of method if other than guideline:

Local Lymph Node Assay: Application of a 10% suspension in DMSO - the highest test item concentration, which could be technically used. Application of 25 µl spread once per day over the entire dorsal surface of each ear for 3 consecutive days.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Initiator 94

IUPAC Name:

Initiator 94

Test material form:

other: liquid

Details on test material:

Name: Initiator 94
Batch: 004IN11
according to certificate of analysis and its addendum of 1. August 2012:
purity: 32% (main component and active species: benzpinakolsilylethers)
further composition: Phosphoric acid tributylester (Tributylphosphat) 19.3%,
1,2-Benzenedicarboxylic acid-di-2-propenylester (Diallylphthalate) 8.7%; Methylbenzene (toluol) 12.9%;
Diphenylmethanone (Benzophenon) 12.4 %;
1,1,2,2-Tetraphenylethane-1,2-diol (Benzpinakol) 14.6%
density: 1.13 g/cm3 at 20°C
Production date of batch: 16.05.2011

Test animals

Species:

mouse

Strain:

CBA

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, NL-5960 AD Horst, The Netherlands
- Age at study initiation: pre-test: 11-12 weeks, main study: 9-10 weeks
- Housing: groupwise
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2 °C
- Humidity (%): 45 - 65%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

open

Preparation of test site:

other: no preparation

Vehicle:

other: DMSO

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2,98 mg per ear per day (calculated)
- Concentration (if solution): 10%

VEHICLE
- Amount(s) applied (volume or weight with unit): 25 µl per ear per day
- Concentration (if solution): 10%
- Purity: 99.5%

Duration of treatment / exposure:

3 consecutive days

Observation period:

2 days

Number of animals:

4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

/ for 10 % concentration

Basis:

mean

Remarks:

/ one animal tested in MAIN -TEST

Time point:

other: day 2-4

Max. score:

1

Reversibility:

other: not examined

Remarks on result:

other: Animals with 5% test solution did not show signs of local skin irritation

Results 2

Irritation parameter:

erythema score

Remarks:

/ for 10 % concentration

Basis:

mean

Remarks:

/ one animal tested in PRE-TEST

Time point:

other: day 1-4

Max. score:

2

Reversibility:

other: not examined

Remarks on result:

other: Erythema Score was 1 for Animals with 5 % test item concentration.

Irritant / corrosive response data:

Main test:
On days 2-4 the animals treated with a test item concentration of 10 % showed an erythema of the ear skin (Score 1). Animals treated with lower test item concentrations did not show any singns of local skin irritation.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Initiator 94 was not a skin sensitiser.
Initiator 94 is irritating to the skin when applied in concentrations of 10% or higher.

Executive summary:

In a sensitisation toxicity study the test item Initiator 94 was formulated in DMSO.

A local lymphnode assay was performed. Concentrations of the test item of 0 %, 2.5%, 5 % and 10 %. in 25 µl DMSO/ear/day were applied to the dorsal surface of the ears of groups of 4 female mice on 3 consecutive days. The highest concentration was the highest level that could be achieved with an applicable formulation.

The animals did not show any signs of systemic toxicity. The test item was not a skin sensitiser.

On days 2 -4 the animals treated with a test item concentration of 10 % showed an erythema of the ear skin (score 1). Animals treated with lower test item concentrations did not show any signs of local skin irritation.

Initiator 94 is irritating to the skin when applied in concentrations of 10% or higher.