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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
Study period:
23 Jan 2009 - 03 Mar 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 2819-2840 kg
- Housing: Individually housed in cages with suspended metal slat floors elevated above fecal pans.
- Diet: Certified Rabbit HF (PMI Nutrition International), Lab Diet 5325
- Water: municipal water, further purified by reverse osmosis, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 40-70
- Air changes (per hr): 14.7
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal area
- Type of wrap if used: elastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any remaining material was wiped from the skin using gauze moistened with reverse-osmosis water followed by dry gauze.
- Time after start of exposure: 4 hours

SCORING SYSTEM: EEC Primary Irritation Index was calculated per EEC and EPA guidelines.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48,72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48,72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No signs of dermal irritation, erythema and oedema were seen at any scoring interval throughout the study on any animal. There were also no notable lesions or any additional dermal findings noted during experimental phase.
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritation study for dodecamethylpentasiloxane reports the test material to be not irritating to skin. The study was conducted according to OECD TG 404 and in compliance with GLP.