Registration Dossier
Registration Dossier
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EC number: 298-130-8 | CAS number: 93777-98-1
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:
- 1988-08-05 to 1990-04-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- 6 animals used.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine
- EC Number:
- 253-634-7
- EC Name:
- 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine
- Cas Number:
- 37697-65-7
- Molecular formula:
- C13H33N3Si
- IUPAC Name:
- N,N',N''-tri-sec-butyl-1-methylsilanetriamine
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: adult
- Weight at study initiation: 2.40 - 2.65 kg
- Housing: individually hosted in polystyrene cages
- Diet: 150 g per rabbit per day of complete pelleted rabbit maintenance diet
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 -23
- Humidity (%): 36 - 75 % R.H.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- 3 minutes (group 1) or 4 hours (group 2)
- Observation period:
- 14 days (at 1h, 24h, 48h and 72h)
- Number of animals:
- 6 males per group (2 groups)
- Details on study design:
- TEST SITE
- Area of exposure: back and flank
- % coverage: no data
- Type of wrap if used: semi-occlusive dressing (perforated adhesive tape, applied on a band of gauze)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 3 minutes or 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:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- whole application area 'burned' by day 7 of observation. Desquamation by day 14.
- Remarks on result:
- other: corrosion
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Whole application area 'burned' by day 7 of observation. Desquamation by day 14.
- Remarks on result:
- other: corrosion
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- whole application area 'burned' by day 7 of observation.
- Remarks on result:
- other: corrosive
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- whole application area 'burned' by day 7 of observation. Desquamation by day 14.
- Remarks on result:
- other: corrosive
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- whole application area 'burned' by day 7 of observation. Desquamation by day 14.
- Remarks on result:
- other: corrosive
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- whole application area 'burned' by day 7 of observation. Desquamation by day 14.
- Remarks on result:
- other: corrosive
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The erythema observations of group 1 (3 minutes application) showed that less than a quarter or half of the treated area, in all the individuals, was burnt. Dryness of the treated area could be also observed 72 hours post-treatment. Very slight edema was noted in 4 individuals, within the observation period.
The erythema observations of group 2 (4 hours application) showed that the treated area was necrotic and dry throughout the whole observation period. Slight to moderate edema was reported in most of the individuals within 72 hours post-exposure. - Other effects:
- The severe lesions in group 1 (3 minutes application) at 72-hour observation, were reported to be noticeably reversible within 14 days post-application. However, when the test substance was applied for 4 hours to the area in group 2, no reversibility could be observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- The skin irritation study, conducted according to OECD TG 404 and in compliance with GLP, reports that the substance, 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine, is corrosive.
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