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Toxicological information

Skin irritation / corrosion

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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:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
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
Qualifier:
according to
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. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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.