Registration Dossier
Registration Dossier
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EC number: 242-042-4 | CAS number: 18162-48-6
Endpoint summary
Administrative data
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
- 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.
Reference
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).
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