Registration Dossier
Registration Dossier
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EC number: 215-214-1 | CAS number: 1313-97-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 August 1984 - 3 September 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Neodymium oxide
- EC Number:
- 215-214-1
- EC Name:
- Neodymium oxide
- Cas Number:
- 1313-97-9
- Molecular formula:
- Nd2O3
- IUPAC Name:
- dineodymium(3+) trioxidandiide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Albino New Zealand
- Sex: males
- Age at study initiation: no data
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: individual housing, in polystyrene cages, of internal dimensions 540 x 360 x 315 mm, with a perforated floor
- Diet: ad libitum, 150 g of complete maintenance food per rabbit per day
- Water: ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 12 to 14 times per hour (pre-filtered air : 5 - 10 µl)
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 1 August 1984 To: data not available
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Concentration: 0.5 g of the test material was applied as a paste with 0.16 mL of water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: a surface of about 6 cm²
- % coverage: no data
- Type of wrap: semiocclusive dressing: covered with a Codex hydrophilic eight layer gauze pad 2.5 cm per side, followed by 10 cm wide adhesive perforated tape (Peloplast: M.S.R.) applied on a crimped gauze bandage (Creplux-Molinier) covering more particularly the whole clipped surface (to avoid possible orthoergic reactions) and wrapped around the animal (without blocking the respiratory and abdominal movements).
REMOVAL OF TEST SUBSTANCE
- Washing: the bandages were removed and if necessary excess test material, which had not penetrated, was wiped away with a gauze pad moistened with distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (edges raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- No irritation observed.
- Other effects:
- No data available.
Any other information on results incl. tables
Table 1 Summary of Erythema Scores
Animal Number |
Mean Score over 24, 48 and 72 hours |
1 |
0 |
2 |
0 |
3 |
0 |
4 |
0 |
5 |
0 |
6 |
0 |
Mean |
0 |
Table 2 Summary of Oedema Scores
Animal Number |
Mean Score over 24, 48 and 72 hours |
1 |
0 |
2 |
0 |
3 |
0 |
4 |
0 |
5 |
0 |
6 |
0 |
Mean |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- According to this study, the test material is not classified as a dermal irritant.
- Executive summary:
A dermal irritation study was conducted in accordance with the standardised guideline OECD 404.
Six male New Zealand White rabbits were dermally exposed to 0.5 g of the test material moistened with 0.16 mL of water to form a paste. Test sites were covered with a semi-occlusive dressing for 4 hours, followed by observation of the animals for 14 days. Irritation was evaluated based on erythema and oedema reactions observed 1, 24, 48 and 72 hours after the end of application.
No skin reactions were observed during the study. The mean score for the readings at 24, 48 and 72 hours for both erythema and oedema was equal to 0.
Under the conditions of this study, the test material is not classified for dermal irritation.
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