Registration Dossier
Registration Dossier
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EC number: 939-498-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted April 04, 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
- Molecular formula:
- Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
- IUPAC Name:
- Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
- Details on test material:
- - Name of test material (as cited in study report): SAT 970396, DHW 80
- Physical state/colour: beige wax
- Lot/batch No.: 128/6
- Expiration date of the lot/batch: 1998-10-17
- Storage condition of test material: room temperature, dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: SPF albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Center A/S, Ejby, DK-4623 Lille Skensved
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: rabbits were caged individually in PPO cages (floor arear: 1576 cm²) with perforated floor
- Diet: pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe; ad libitum; analysis for nutritive components and relevant possible contaminants were performed regularly
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 to prevent microbial growth; ad libitum; analysis for relevant possible contaminants were performed regularly
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10 times
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1997-07-29 To: 1997-08-02
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
reading time points 24, 48, 72 hours - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 16-layer gauze patches were secured with 2.5 cm wide adhesive Gothaplast tape and fixed with Gothaplast tape, 5 cm width
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin was cleaned with mild soap and lukewarm water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Draize scorimg system according to OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals 2 and 3
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- other: mean over 24 to 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- One hour after termination of exposure animal #1 showed a well-defined erythema and a very slight oedema. In animals #2 and #3 a very slight erythema was seen. After 24 hours only animal #1 showed a very slight erythema.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In compliance with the criteria for the classification and labelling of substances and preparations in the european Union, laid down in the directive 67/548/EEC Annex VI including 7th amendment 92/32/EC Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia, tech. has not to be classified and labelled as irritating to skin.
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