Registration Dossier
Registration Dossier
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EC number: 407-830-6 | CAS number: 103335-54-2 DELTA-5-AZA-ACID
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-10-04 - 1995-10-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The method used followed that described in the OECD Guidelines for Tesing of Chemicals No. 404 'Acute Dermal Irritation/Corrosion' (adoped 17 Jul 1992) and Method B4 of 67/548/EEC.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-oxo-4-azaandrost-5-ene-17β-carboxylic acid
- EC Number:
- 407-830-6
- EC Name:
- 3-oxo-4-azaandrost-5-ene-17β-carboxylic acid
- Cas Number:
- 103335-54-2
- Molecular formula:
- Hill formula: C19H27NO3 CAS formula: C19H27NO3
- IUPAC Name:
- 4a,6a-dimethyl-2-oxo-1H,2H,3H,4H,4aH,4bH,5H,6H,6aH,7H,8H,9H,9aH,9bH,10H-indeno[5,4-f]quinoline-7-carboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): GR91287X
- Molecular formula (if other than submission substance): C19-H27-N-O3
- Molecular weight (if other than submission substance): 317.43
- Analytical purity: >95%
- Lot/batch No.: CO-0099
- Storage condition of test material: room temp in dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd
- Age at study initiation: 12- 16 weeks
- Weight at study initiation: 2.22 - 2.48 kg
- Housing: suspended metal cages
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: min 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 56- 70
- Air changes (per hr): ca 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: To: 1995-10-04 - 1995-10-07
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistened with 0.5 ml water.
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 ml water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1h, 24, 48 and 72hrs.
- Number of animals:
- 3 males.
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4hrs
SCORING SYSTEM: Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (Male) 155
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects recorded.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (Male) 162
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects recorded.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (Male) 581
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects recorded
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (Male) 155
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects recorded
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (Male) 162
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects recorded
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (Male) 581
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects recorded
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test material, GR91287X, produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize grading scheme. No corrosive effects were noted.
- Executive summary:
GR91287X did not meet the criteria necessary for classification as irritant or corrosive to skin. according to EC labelling regulations. No symbol or risk phrase are required.
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