Registration Dossier
Registration Dossier
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EC number: 218-657-9 | CAS number: 2212-10-4
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See endpoint summary for justification of read-across.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 09 August 2011 to 14 August 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- (1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008, L 142, Annex Part B (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayrisches Landesamt für Gesundheit ud Lebensmittelsicherheit, Munich, Germany
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Crl: KBL (NZW)
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany (The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals were bred for experimental purposes.)
- Age at study initiation: approximately 15 – 16 weeks
- Weight at study initiation: > 2kg
- Housing: in ABS - plastic rabbit cages, floor 4200 cm² (Semi barrier in an air-conditioned room)
- Diet: autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 1415), rich in crude fibre, ad libitum
- Water: tap water (drinking water, municipal residue control, microbiological controls at regular intervals), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3 (recommendations of TVT [10], GV-SOLAS [11])
- Humidity (%): 55±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- The animals were examined for signs of erythema and oedema 1 hour after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema 24, 48 and 72 hours after the patch removal.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: the residual test material was removed with tap water.
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No irritant or corrosive effects were observed on the intact skin of the three female rabbits after a contact time of 4 hours.
- Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed. The body weight was not affected by the test item application.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was tested for its skin irritating properties according to the OECD TG 404 and in compliance with GLP. No irritant effects were noted during the 72 h observation period following 4 h of exposure. No deaths occured, no signs of systemic toxicity were reported, and the body weight was not affected by the treatment. Hence, classificaion for skin irritation according to 67/584/EEC and EC/1272/2008 is not warranted.
Data source
Materials and methods
Test material
- Reference substance name:
- (chloromethyl)diethoxymethylsilane
- EC Number:
- 218-657-9
- EC Name:
- (chloromethyl)diethoxymethylsilane
- Cas Number:
- 2212-10-4
- Molecular formula:
- C6H15ClO2Si
- IUPAC Name:
- (2-chloro-1,1-diethoxyethyl)silane
- Test material form:
- liquid
- Details on test material:
- Purity approx. 99% (GC)
Constituent 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 90% solution, intact skin; 50% solution, intact skin; 90% solution abraded skin; 50% solution abraded skin
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 90% solution, intact skin; 50% solution, intact skin; 90% solution abraded skin; 50% solution abraded skin
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 90% solution, intact skin; 50% solution, intact skin; 90% solution abraded skin; 50% solution abraded skin
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 90% solution, intact skin; 50% solution, intact skin; 90% solution abraded skin; 50% solution abraded skin
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 90% solution, intact skin; 50% solution, intact skin; 90% solution abraded skin; 50% solution abraded skin
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 90% solution, intact skin; 50% solution, intact skin; 90% solution abraded skin; 50% solution abraded skin
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
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