Registration Dossier
Registration Dossier
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EC number: 600-768-2 | CAS number: 106726-11-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- neodymium(3+) 2-ethyl-2,5-dimethylhexanoic acid tris(2-ethyl-2,5-dimethylhexanoate)
- EC Number:
- 600-768-2
- Cas Number:
- 106726-11-8
- Molecular formula:
- C30H57NdO6
- IUPAC Name:
- neodymium(3+) 2-ethyl-2,5-dimethylhexanoic acid tris(2-ethyl-2,5-dimethylhexanoate)
- Test material form:
- solid
- Details on test material:
- Name of test substance in the report: Neodym-Versatat
Appearance: solid
Molecular weight: 657 g/mole
Molecular formula: C30H57NdO6
Constituent 1
- Specific details on test material used for the study:
- Name of test substance in the report: Neodym-Versatat
Appearance: solid
Molecular weight: 657 g/mole
Molecular formula: C30H57NdO6
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd, Huntingdon, UK or Interfauna UK Ltd.
- Weight at study initiation: 2.8, 3.2, and 3.4 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 45-64%
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light): 12 hours
IN-LIFE DATES: September 1985
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: pasted with water
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the solid pasted with water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: shaved, uncompromized skin on the flanks of 6 cm²
- Type of wrap if used: semiocclusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing with water after treatment
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
1, 24, 48, and 72 hours after treatment and on day 7 and 14 after treatment
SCORING SYSTEM:
- Method of calculation: Draize (according to OECD 404)
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- animal: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no skin irritating effects (erythema and edema) were observed 1, 24, 48, 72 hours and 7 days after patch removal; the experiment was therefore stopped after 7 days
Applicant's summary and conclusion
- Executive summary:
In a skin irritation study on 3 rabbits performed in 1985 according to OECD 404 the solid test substance pasted with water did not show any indication of irritating effects. The mean irritation score was derived with 0.0.
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