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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 June to 22 June 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
018162-48-6
Cas Number:
018162-48-6
IUPAC Name:
018162-48-6
Constituent 2
Chemical structure
Reference substance name:
tert-butylchlorodimethylsilane
EC Number:
242-042-4
EC Name:
tert-butylchlorodimethylsilane
Cas Number:
18162-48-6
Molecular formula:
C6H15ClSi
IUPAC Name:
tert-butyl(chloro)dimethylsilane
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Germany
- Age at study initiation: not stated
- Weight at study initiation: 3.4 kg
- Housing: ABS plastic rabbit cages
- Diet (ad libitum): Altromin 2123 rabbit maintenance diet
- Water (ad libitum): tap water
- Acclimation period: stated as "adequate"

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/- 3
- Humidity (%): 45-65
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 7 June 2005 To: 22 June 2005

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
other: untreated side of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5g

Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
1 female
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm2
- Type of wrap if used: gauze patch held in place with non-irritating tape, patch was fixed with semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: not stated
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 0 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Day 2 to Day 12
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Day 13 to 14
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 0 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: Day 2 to 12
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: Day 13 to 14
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
After patch removal the application site showed necrotic skin over the whole application area. Necrotic tissue covered the application area for 12 days showing erythema grade 2 and edema grade 2 at the edge of the application area the first day after application. Erythema and edema at the edge of the application area decreased to grade 1 on Day 2 and continued at grade 1 until the end of the study. The necrotic tissue dropped off the application area on Day 13, showing an open wound, only covered with a gauzy dry film, at the edges the skin was dry and necrotic. Similar observations were recorded on Day 14. No further animals were treated.
Other effects:
Slight weight loss, approximately 6%, was noted during the 14 day observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
Tert-butyl(chloro)dimethylsilane causes severe corrosive effects to rabbit skin.