Registration Dossier
Registration Dossier
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EC number: 294-705-2 | CAS number: 91745-35-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 days
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Modern GLP study conducted in accordance with modern guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Individual animal bodyweight data at the start and end of the test are not provided in the study report
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Individual animal bodyweight data at the start and end of the test are not provided in the study report
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates
- EC Number:
- 294-705-2
- EC Name:
- Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates
- Cas Number:
- 91745-35-6
- Molecular formula:
- C72H140N2O3-C80H156N2O3
- IUPAC Name:
- Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates
- Details on test material:
- Batch number: E0011-039E
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK
- Age at study initiation: 12–20 weeks of age
- Weight at study initiation: 2.0–3.5 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): set to achieve 17–23 deg C
- Humidity (%): set to achieve 30–70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12 (06:00–18:00)
IN-LIFE DATES:
From: 24/01/08 To: 27/01/08
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g test material, moistened with 0.5 ml distilled water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- 0.5 g of test material moistened with 0.5 ml of distilled wwater was introduced under a 2.5cm x 2.5cm cotton gauze patch and placed in position on the shorn dorsal/flank skin. The patch was secured in place with a strip of surgical tape. To prevent animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset.
After four hours of exposure, the corset and patches were removed and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
Test sites were examined and scored for for evidence of primary irritation using the Draize scale, 1, 24, 48 and 72 hours after patch removal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: No erythema was observed in any animal at any time point
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: No oedema was seen in any animal at any time point
- Irritant / corrosive response data:
- The primary irritation index was 0 (zero).
- Other effects:
- No other effects were reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test material was not irritating to the skin of rabbits in this test.
- Executive summary:
The test material was evaluated for dermal irritation potential in three male New Zealand white rabbits, in accordance with OECD Test Guideline 404. The test material was applied to each animal at a dose of 0.5g, moistened with 0.5ml distilled water, and held in place using a semi-occlusive dressing. After four hours the patches and residual test material were removed. Test sites were observed for evidence of erythema and oedema 1, 24, 48 and 72 hours after patch removal.
There was no evidence of irritation, measured either as erythema or oedema, in any animal at any time point.
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