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EC number: 221-328-2 | CAS number: 3068-76-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 402 (Acute dermal toxicity)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[3-(trimethoxysilyl)propyl]aniline
- EC Number:
- 221-328-2
- EC Name:
- N-[3-(trimethoxysilyl)propyl]aniline
- Cas Number:
- 3068-76-6
- Molecular formula:
- C12H21NO3Si
- IUPAC Name:
- N-[3-(trimethoxysilyl)propyl]aniline
- Details on test material:
- - Name of test material (as cited in study report): SILQUEST Y-9669 Silane
- Physical state: clear colourless liquid
- Analytical purity: 99.4%
- Lot/batch No.: 16166-67
- Storage condition of test material: original container at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, MI, USA
- Age at study initiation: young adult
- Weight at study initiation: 220-267 g
- Fasting: 18-20 h prior to dosing until 3-4 after dosing
- Housing: individual housing in mesh-bottom cages
- Diet: Purina Certified Rodent Chow #5002, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.1±0.2
- Humidity (%): 39.1-44.0
- 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): 2000 mg/kg bw (1.97 mL/kg) - Duration of treatment / exposure:
- 24 h
- Observation period:
- 14 d
- Number of animals:
- 5 animals per sex
- Details on study design:
- TEST SITE
- % coverage: 14-18% of total body surface
- Type of wrap if used: gauze bandaging secured with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): application sites were wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw, 1.92 mL/kg
SCORING SYSTEM: Draize scoring system
OTHER OBSERVATIONS:
- Frequency of observations and weighing: The rats were observed 1, 3, and 4 h post-dose on day of appplication (day 0) and once daily (clinical observation) or twice daily (mortality) thereafter. Body weights were obtained on the day of treatment and on day 7 and 14.
- Necropsy of survivors performed: yes (major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals)
- Dermal observations: application sites were examined for erythema, oedema and other dermal findings 30-60 minutes after bandage removal and daily thereafter for thirteen days. The rats were clipped to facilitate dermal observations on study days 7 and 14.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 10 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Desquamation was observed in 6/10 animals (fully reversible in 4/6 animals). Eschar was observed in 1/10 animals (day 11-14). Erythema (grade 4) and edema (grade 1) were observed in 1 animal at the end of the study.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 5 males
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The test material induced very slight to severe erythema, very slight edema and eschar on one animal. Desquamation was present on six animals. There were no other dermal findings. With the exception of one male and female with severe erythema, slight edema, eschar and/or desquamation, all dermal irritation completely subsided by day 11 or earlier.
Any other information on results incl. tables
Table 2: Dermal observations of the males in the acute dermal toxicity study.
Rat No. (males) |
1 |
2 |
3 |
4 |
|
5 |
|
|||
Observation time [day no] |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
1 |
0d |
0 |
0d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0d |
0 |
0d |
0 |
0 |
0 |
0 |
0 |
0d |
0 |
5 |
0d |
0 |
0d |
0 |
0 |
0 |
0 |
0 |
0d |
0 |
6 |
0d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
0d |
0 |
0 |
0 |
0d |
0 |
0 |
0 |
0 |
0 |
8 |
0d |
0 |
0 |
0 |
0d |
0 |
0 |
0 |
0 |
0 |
9 |
0d |
0 |
0 |
0 |
0d |
0 |
0 |
0 |
0 |
0 |
10 |
0d |
0 |
0 |
0 |
0d |
0 |
0 |
0 |
0 |
0 |
11 |
0d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
12 |
0d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
13 |
0d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
14 |
0d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
d: desquamation
Table 3: Dermal observations of the females in the acute dermal toxicity study.
Rat No. (females) |
1 |
2 |
3 |
4 |
|
5 |
|
|||
Observation time [day no] |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0d |
0 |
0 |
0 |
0 |
0 |
0d |
0 |
5 |
0 |
0 |
1d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
1d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
2d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
0 |
0 |
2d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
0 |
0 |
3d |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
0 |
0 |
3d |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
11 |
0 |
0 |
4de |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
12 |
0 |
0 |
4de |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
13 |
0 |
0 |
4de |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
14 |
0 |
0 |
4de |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
d: desquamation
e: eschar
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
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