Registration Dossier
Registration Dossier
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EC number: 213-668-5 | CAS number: 999-97-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04.10.1993 to 12.10.1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1,1,3,3,3-hexamethyldisilazane
- EC Number:
- 213-668-5
- EC Name:
- 1,1,1,3,3,3-hexamethyldisilazane
- Cas Number:
- 999-97-3
- Molecular formula:
- C6H19NSi2
- IUPAC Name:
- bis(trimethylsilyl)amine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton, Michigan, USA.
- Age at study initiation: No data
- Weight at study initiation: 2.98 - 3.09 kg
- Housing: Individually in conventional design stainless steel cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled, but no data
- Humidity (%): Controlled, but no data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): Controlled, but no data
IN-LIFE DATES: From: 04.10.1993 to 12.10.1993
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Seven days (1, 24, 48, 72 hours and 7 days)
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal trunk
- % coverage: No data
- Type of wrap if used: The application site was covered with porous gauze dressing and then wrapped in a semi-occlusive fashion with a cotton bandage taped to the hair.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: four hours
SCORING SYSTEM: The 4 point scale cited in the OECD guideline (404) was used.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.22
- Max. score:
- 8
- Reversibility:
- fully reversible within: Seven days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- 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
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- 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
- 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
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation was observed at the one-hour reading following the four hour exposure. Erythema was seen in two of the three animals following the four-hour exposure. Erythema was observed at 24, 48 and 72 hours in two rabbits. All signs of irritation had subsided by the seventh day observation period. The third animal showed no signs of irritation during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3, EC 213-668-5) did not cause significant irritation and
was not corrosive to the rabbit skin.
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