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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:
2001-09-18 to 2001-09-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
other: Commission Directive 92/69/EEC, Annex Part B, Method B4 Acute Toxicity (Skin Irritation)
Qualifier:
according to
Guideline:
other: US EPA: OPPTS 870.2500, Health Effects Test Guidelines: Acute Dermal Irritation, August 1998
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: no data
- Weight at study initiation: 3.38 - 3.52 kg
- Housing: in separate cages arranged in battery
- Diet: ssniff K-H (V2333), ad libitum and hay approximately 15 g a day
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL


Duration of treatment / exposure:
4 hours
Observation period:
At 30 and 60 min, then at 24, 48 and 72 hours post-application
Number of animals:
3 female animals
Details on study design:
TEST SITE
- Area of exposure: dorsal region
- % coverage: no data. 25 cm² area of the total body surface was treated
- Type of wrap if used: surgical plaster covered with semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water was used to remover residual test item
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed in any of the animals during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the skin irritation study the test substance, 1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane, was concluded to be not irritating to rabbit skin.