Registration Dossier
Registration Dossier
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EC number: 221-336-6 | CAS number: 3069-29-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 and 19 July 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
- EC Number:
- 221-336-6
- EC Name:
- N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
- Cas Number:
- 3069-29-2
- Molecular formula:
- C8H22N2O2Si
- IUPAC Name:
- N-[3-[dimethoxy(methyl)silyl]propyl]ethane-1,2-diamine
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, England
- Age at study initiation: minimum of 11 weeks
- Weight at study initiation: 2.3-2.7kg
- Housing: individually housed in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13-27.5
- Humidity (%): 38-68
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Examination of the treated skin was made at 1, 24, 48, 72 hours after exposure. Additional observations were made for all animals on days 5 through 10 and two animals on days 11 through 14.
- Number of animals:
- 1 male, 2 females
- Details on study design:
- TEST SITE
- Area of exposure: dorso-lumbar region
- Type of wrap if used: gauze pad, and elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm water
- Time after start of exposure: 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:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Well-defined to moderate to severe erythema with slight oedema was observed in all three animals. In addition, desquamation of the corneum stratum (characterised by dryness and sloughing) was seen in three animals, thickening of the skin in two animals and cracking of the skin in one animal. Reactions gradually ameliorated and had resolved completely in one animal by day 10, however, very slight to well-defined erythema was still present in the remaining two animals at study termination on day 14.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In a reliable study conducted according to OECD Test Guideline 404 and in compliance with GLP, the test material is concluded to be a Category 2 skin irritant, based on the erythema reading of 3 in two of the tested animals from the gradings at 24, 48 and 72 hours after patch removal.
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