Registration Dossier
Registration Dossier
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EC number: 600-768-2 | CAS number: 106726-11-8
Endpoint summary
Administrative data
Description of key information
skin: no irritation
eye: no irritation
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- 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 - 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 - 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) - 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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- 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 - Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- HC:NZW
- Details on test animals or tissues 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 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): volume of 100 µL (correlates to 75 mg) - Duration of treatment / exposure:
- the treated eye was held closed for 1 second after application of the test item
- Observation period (in vivo):
- 1, 24, 48, 72 hours and 7 days after treatment
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- tissues investigated: cornea (opacity and area of opacity), iris and conjunctivae (redness, edema, lacrimation)
- 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:
- 1 hour after instillation in all three animals a slight redness (score 1.0) was observed that was due to the mechanical irritation of the solid test item in the eyes; no indication of irritation became obvious at the time points 24/48/72 hours and 7 days after treatment; the study was thus terminated after 7 days
- Executive summary:
In an eye irritation study on 3 rabbits performed in 1985 according to OECD 405 the solid test substance (volume 100 µL, according to 75 mg) was instilled in one eye of each rabbit. The other eye served as control. No eye irritation became obvious and the irritation score was thus 0.0 for the time points 24/48/72 hours after treatment.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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.
In an eye irritation study on 3 rabbits performed in 1985 according to OECD 405 the solid test substance (volume 100 µL, according to 75 mg) was instilled in one eye of each rabbit. The other eye served as control. No eye irritation became obvious and the irritation score was thus 0.0 for the time points 24/48/72 hours after treatment.
Justification for classification or non-classification
Based on the available Guideline studies for skin and eye irritation in rabbits no classification is warranted for skin and eye irritation.
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