Registration Dossier
Registration Dossier
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EC number: 233-487-5 | CAS number: 10196-49-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: CFR, title 16, section 1500.41
- GLP compliance:
- no
- Remarks:
- study conducted prior to implementation of GLP
Test material
- Reference substance name:
- 2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane
- EC Number:
- 233-487-5
- EC Name:
- 2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane
- Cas Number:
- 10196-49-3
- Molecular formula:
- C6H15NOSi
- IUPAC Name:
- 2,2,4-trimethyl-1,4,2-oxazasilinane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Extertal 1
- Weight at study initiation: 2.6 kg (average)
- Housing: each animal in separate cage
- Diet (e.g. ad libitum): mümmel z (sniff / Soest), ad libitum
- Water: ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°C
- Humidity (%): 40% r.h.
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved (left flank); shaved and scarified (right flank)
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 µL of liquid test substance Aktivator MO - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 30 min after end of exposure (24h) as well as 48 h (not reported in table of results) and 72 h after start of exposure, control observation on day 8 (not considered for scoring).
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5cm on 8x8cm skin
- Type of wrap if used: double layer of substance saturated surgical dressing, covered with PVC-film, fixed with Leukoflex and wrapped with elastic bandage.
OBSERVATION TIME POINTS
24/48/72 hours, control observation on day 8
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- grey/brown staining, later dry corrosion scab
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- not scored
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- grey/brown staining, later dry corrosion scab
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- grey/brown staining, later dry corrosion scab
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- not scored
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- grey/brown staining, later dry corrosion scab
- Irritant / corrosive response data:
- grey/brown staining within 24 hours, first with soft and later hard and dry corrosion scab
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test substance was corrosive in the in vivo skin irritation test under the experimental conditions described in this report.
- Executive summary:
In a primary dermal irritation study performed in accordance with the Code of Federal Regulations, Title 16, Section 1500.41, adult male albino rabbits (strain New Zealand White) were dermally exposed to 500 µL of the test substance for 24 hours to 6.25-64 cm² body surface area. Animals then were observed for 8 days. Irritation could not be scored due to corrosive effects.
Corrosion occurred during the observation period.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Skin Corr. 1 (H314: Causes severe skin burns and eye damage) is justified.
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