Registration Dossier
Registration Dossier
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EC number: 236-818-1 | CAS number: 13497-18-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 – 30 Sep 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
Test material
- Reference substance name:
- Bis(triethoxysilylpropyl)amine
- EC Number:
- 236-818-1
- EC Name:
- Bis(triethoxysilylpropyl)amine
- Cas Number:
- 13497-18-2
- Molecular formula:
- C18H43NO6Si2
- IUPAC Name:
- bis(triethoxysilylpropyl)amine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand White Rabbits Crl:KBL (NZW)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 22 - 30 weeks old
- Weight at study initiation: > 2 kg
- Housing: ABS-plastic rabbit cages, floor 4200 cm²
- Diet: autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 0724) ad libitum rich in crude fibre
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: An untreated patch at the right side of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
Reading time points: 1, 24, 48 and 72 h and continued for day 4 to day 14 - Number of animals:
- 2 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the left side of the dorsal area
- Type of wrap if used: gauze was held in place with a non-irritating tape, patch was fixed with semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, at the end of the exposure period (4 h) the residual test item was removed with tap water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
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 fully reversible within: 14 days
- 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 #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritant / corrosive response data:
- After 1 h both animals showed erythema and oedema reactions (grade 1). The erythema scores were increasing up to 72 h (grade 2), and were not fully reversible within 14 days. Edema scores increased after 24 h (grade 2) only in animal 1, but were fully reversible within 72 h (animal 1) to 5 days (animal 2). Desquamation was observed at the treated site in animal 1 from day 4 to 7 and in animal 2 from day 6 to 8.
- Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed. There were no significant body weight changes during the contact and observation period.
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:
- CLP: Skin irrit 2, H315
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