Registration Dossier
Registration Dossier
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EC number: 453-230-2 | CAS number: 406679-89-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-27 until 2003-09-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD test under GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 453-230-2
- EC Name:
- -
- Cas Number:
- 406679-89-8
- Molecular formula:
- Hill formula: C5H11NO3Si CAS formula: C5H11NO3Si
- IUPAC Name:
- (isocyanatomethyl)dimethoxymethylsilane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: 3.7 - 3.9 kg
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 55 +/- 10 % rel. humidity
- Air changes (per hr): at least 10/h
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated but shaved other side served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- As all animals showed signs of irritation at the 72 hours readings, observation time was prolonged until 168 hours after dosing
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: gauze patch held with non-irritating tape
SCORING SYSTEM: as stated in Guideline OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 168 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 168 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 168 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- No other clinical signs of toxicity were found. There were no significant body weight changes during the contact and observation period
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Considering the reported data of this irritation study it can be stated that the test item showed slight irritant, but no corrosive effects.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 EEC) the test item SLM 449019 does not have to be classified and has no obligatory labelling requirement for skin irritation. - Executive summary:
An acute dermal Irritation/Corrosion test according to OECD 404 was performed. The test item was semi-occlusively applied to the skin on 3 female New Zealand White Rabbits HsdIf:NZW and held in contact throughout a 4 hour period. The test item showed slight irritant effects on the intact skin after a contact time of 4 hours. All animals showed erythema grade 1 at the 1 h, 24 h, 48 h, 72 h, 96 h, 120 h as well as 144 hours readings after removal of the dressing. No signs of irritation were recorded for any animals at the 168 hours readings. No other clinical signs of toxicity were found. There were no significant body weight changes during the contact and observation period. Therefore, the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.
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