Registration Dossier
Registration Dossier
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EC number: 213-909-4 | CAS number: 1066-30-4
Eye irritation
Administrative data
- Endpoint:
- eye 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: Guideline study with limited documentation
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:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Remarks:
- reporting in publication not as detailed as in a guideline study report
- 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 / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or tissues 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: 7 days prior to initiation of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- water
- Controls:
- other: left eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (0.05 g) of NBC in water - Duration of treatment / exposure:
- Application into the conjuntival sac lasted for appr. 1 sec. The test substance remained in the eye.
- Observation period (in vivo):
- 1, 24, 48, and 72 h post-installation
- Number of animals or in vitro replicates:
- two males, one nulliparous and non-pregnant female
- Details on study design:
- SCORING SYSTEM: primary eye irritation score according to system by Kay and Calandra 1962; eye lesions were scored were scored according to Draize scale
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- other: conjunctivitis incidence
- Basis:
- other: per three animals
- Time point:
- other: 1 h
- Score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- No corneal opacity or iritis was observed in any treated eye during the study. One hour following test substance instillation, all treated eyes exhibited conjunctivitis. All animals were free of ocular irritation within 24 h.
- Other effects:
- Apart from the eye irritation noted, all animals appeared active and healthy. There were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.
Any other information on results incl. tables
Under the conditions of this study niacin-bound chromium is practically non-irritating to the eye.
Table: Incidence, severity and reversibility of ocular irritation in New Zealand albino rabbits after exposure to niacin-boun chromium (n=3)
Time post installation (h) |
Incidence of ocular irritation |
Severity of irritation |
||
Corneal opacity |
Iritis |
Conjunctivitis |
MMT(a) score |
|
1 |
0/3 |
0/3 |
3/3 |
2.0 |
24 |
0/0 |
0/0 |
0/0 |
0.0 |
48 |
0/0 |
0/0 |
0/0 |
0.0 |
72 |
0/0 |
0/0 |
0/0 |
0.0 |
(a) MMT = maximum mean total
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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