Registration Dossier
Registration Dossier
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EC number: 213-909-4 | CAS number: 1066-30-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited documentation
- GLP compliance:
- yes
Test material
- Reference substance name:
- Niacin bound chromium
- IUPAC Name:
- Niacin bound chromium
- Reference substance name:
- ChromeMate® CM-100M
- IUPAC Name:
- ChromeMate® CM-100M
- Details on test material:
- - Name of test material (as cited in study report): Niacin bound chromatin (NBC), niacin-bound chromium complex comercially known as ChromeMate® CM-100M
- Substance type: powder
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: #306013
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services Inc. (Clemmons, NC, USA)
- Diet (e.g. ad libitum): free access to lab chow (Purina Rabbit Chow No. 5326, St. Louis, Mo, USA)
- Water (e.g. ad libitum): municipal water ad libitum
- Acclimation period: 9 days prior to initiation of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24 °C
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: corn oil
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g/pad of the 70% mixture
- Concentration (if solution): 70% w/w mixture of niacin-bound chromium III in corn oil - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours after removal of test substance
- Number of animals:
- one male, two nulliparous and non-pregnant females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100
- Type of wrap if used: 4-ply gauze pad; pad and entire trunk of animal secured with semi-occlusive 3 in. Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle cleaning of any residual test substance
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize Scoring System and calculation of Primary dermal irritation index
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- 1 male, 2 female
- Score:
- 0.5
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- 1 h after the application, very-slight erythema was observed at all three treated sites. The overall incidence and severity of irritation decreased with time. All animals were free from dermal irritation within 48 h.
- Other effects:
- Apart from the dermal irritation noted, all animals appeared active and healthy and with no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.
Any other information on results incl. tables
Table: Primary dermal irritation scores in male and female New Zealand albino rabbitsaafter exposure to niacin-bound chromium
Time post installation (h) |
Incidence of dermal irritation |
Total PDIb |
Primary Dermal Irritation Index (PDII) |
|
erythema |
edema |
Individual |
||
1 |
1.0 |
0.0 |
1.0 |
0.5 |
24 |
1.0 |
0.0 |
1.0 |
|
48 |
0.0 |
0.0 |
0.0 |
|
72 |
0.0 |
0.0 |
0.0 |
|
(a) Average values (n=3), (b) primary dermal irritation = average erythema + avergae edema
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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