Registration Dossier
Registration Dossier
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EC number: 213-926-7 | CAS number: 1067-25-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 - 19 May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- minor deviations: coverage occlusive; limited information on test material (e.g. no data on purity or batch no.)
- GLP compliance:
- no
Test material
- Reference substance name:
- Trimethoxypropylsilane
- EC Number:
- 213-926-7
- EC Name:
- Trimethoxypropylsilane
- Cas Number:
- 1067-25-0
- Molecular formula:
- C6H16O3Si
- IUPAC Name:
- trimethoxy(propyl)silane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian (albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, GERMANY
- Age at study initiation: 6 months
- Weight at study initiation: 2.3-2.8 kg
- Housing: 1/cage
- Diet: standard ad libitum
- Water: drinking water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1987-05-05 To: 1987-05-19
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: neat (100%) - Duration of treatment / exposure:
- 4 h
- Observation period:
- Examination 1, 24, 48, 72 h following removal of patch. Further observation up to 14 days.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: gauze patch, synthetic foil cover, occlusive wrap
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:
- fully reversible within: 8 days
- Remarks on result:
- other: Scaling to the end of the observation period
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Scaling to the end of the observation period
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Scaling to the end of the observation period
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Clear defined erythema and slight edema in all three animals. Scaling to the end of the observation period (14 days).
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
1 h |
1,0,0 |
1,0,1 |
24 h |
2,2,2 |
2,2,2 |
48 h |
2,1,2 |
2,2,2 |
72 h |
2,2,1 |
2,2,2 |
Average 1h, 24h, 48h, 72h |
1.42 |
1.67 |
Irritation index (1h, 24h, 48h, 72h) |
3.1 |
|
Individual mean scores (24h, 48h, 72h) |
2/1.67/1.67 |
2/2/2 |
Erythema or oedema were seen for up to 8 days, scaling continued to study termination at 14 days. (Limited information appear to be presented on observations post-72h.)
No systemic toxicity was reported.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are met, Category 2 (irritant) classification required according to Regulations (EC) No. 1272/2008
- Conclusions:
- In a skin irritation study conducted largely in accordance with OECD 404, but without GLP status (reliability score 2), trimethoxy(propyl)silane was irritating to the skin of rabbits.
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