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Description of key information

In the key skin irritation study corrosive effects were recorded.


In accordance with Column 2 of REACH Annex VII, the in vivo eye irritation study (required in Section 8.2) does not need to be conducted as the available information indicates that the substance meets the criteria for classification as corrosive to skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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)
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
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
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.
Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
Tert-butyl(chloro)dimethylsilane causes severe corrosive effects to rabbit skin.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the key skin irritation study (BSL, 2005) application of tert-butyl(chloro)dimethylsilane to the skin of a rabbit for 4 hours resulted in necrosis of the application site which was noted immediately after patch removal. Erythema and edema were noted from 24 hours after patch removal. Necrosis, erythema and edema continued to be recorded during the 14-day observation period.


Justification for classification or non-classification

Based on the available data tert-butyl(chloro)dimethylsilane requires classification for skin corrosion as Category 1A Corrosive (H314: causes severe skin burns and eye damage) according to Regulation (EC) No 1272/2008 due to necrosis at the application site being recorded immediately after patch removal. Furthermore, skin irritation data from other chlorosilane substances indicates Cat 1A Corrosive classification after a 3 minute exposure period (see attached supporting document, PFA, 2013r).