Registration Dossier
Registration Dossier
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EC number: 217-164-6 | CAS number: 1760-24-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15.10.1998 to 10.02.2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
- EC Number:
- 217-164-6
- EC Name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
- Cas Number:
- 1760-24-3
- Molecular formula:
- C8H22N2O3Si
- IUPAC Name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, England
- Age at study initiation: At least 11 weeks
- Weight at study initiation: 2193-2616 g
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-22
- Humidity (%): 44-78
- Air changes (per hr): 18
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20.10.1998 To: 02.11.1998
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- 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:
- Four hours
- Observation period:
- Up to 14 days
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: 10% approx.
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: Four hours with warm water
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.11
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Remarks on result:
- other: Desquamation from Day 7
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Remarks on result:
- other: Desquamation from Day 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Desquamation from Day 5
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No edema
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No edema
- Irritant / corrosive response data:
- Well-defined erythema in all three animals and slight edema. Desquamation of the stratum corneum developed in all animals. Dermal reactions resolved completely in all animals by Day 10, 11 or 13.
- Other effects:
- No deaths or clinical signs of a systemic reaction to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin irritation study conducted to EPA OPPTS 870.2500 (Acute Dermal Irritation) and to GLP (reliability score 1) N-(3-(trimethoxysilyl)propyl)ethylenediamine was mildly irritating to the skin of rabbits, but this irritation did not meet the EU criteria for classification. There were no clinical signs of toxicity.
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