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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: read-across from constituent CrIII
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
publication
Title:
Safety and toxicological evaluation of a novel niacin-bound chromium (III) complex.
Author:
Shara M, Yasmin T, Kincaid AE, Limpach AL, Bartz J, Brenneman KA, Chatterjee A, Bagchi M, Stohs SJ, Bagchi D.
Year:
2005
Bibliographic source:
J Inorg Biochem. 2005 Nov;99(11):2161-83

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Niacin bound chromium (NBC) is a unique, patented oxygen-coordinated niacin-bound chromium complex commercially known as ChromeMate CM-100M (powder) and was obtained from InterHealth Nutraceuticals, Benicia, CA, USA.
Lot#306013

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc., (Boyertown, PA, USA)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 12 h light/12 h dark
- Weight at study initiation:male and female 298–310 and 199–205 g
- Fasting period before study: not reported
- Housing: not reported
- Diet (e.g. ad libitum): lab chow (Purina Rodent Chow No. 5012, St. Louis, MO, USA)
- Water (e.g. ad libitum): municipal water ad libitum
- Acclimation period: 13 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18–22 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
Doses were calculated based on the initial body weights obtained prior to dosing with a 2000 mg/kg b.w.
On the day prior to application, the hair was removed by clipping the dorsal area and the trunk using an Oster model #A5-small clipper.
After clipping and prior to application, the animals were examined for health, weighed (initial) and the skin checked for any abnormalities.
The test product was moistened with distilled water to achieve a dry paste by preparing a 70% w/w mixture.
The test product was then applied to a 2 inch * 3 inch, 4-ply gauze pad and placed on the animal (approximately 10% of the body surface).
The gauze pad and entire trunk of each animal were then wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to minimize loss of the test substance.
Duration of exposure:
24 h
Doses:
2000 mg/lg bw
No. of animals per sex per dose:
five
Control animals:
no
Statistics:
No statistics due to absence of effects

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 621.6 mg/kg bw
Based on:
act. ingr.
Remarks:
CrIII
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality was observed.
Clinical signs:
No adverse clinical signs were observed. All animals remained active and healthy troughout the observation period.
Body weight:
No reduction in body weight gain.
Gross pathology:
No gross abnormalities were noted for any of the animals at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal toxicity to rats was found as LD50 >2000 mg/kg bw or 621.6 mg/kg bw for CrIII. No mortality was observed and no adverse effects were noted.