Chromium trichloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well documented summary of different GLP toxicological studies (following OECD protocols) performed with niacin-bound chromium (III) complex

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

64452-96-6

Cas Number:

64452-96-6

IUPAC Name:

64452-96-6

Constituent 2

Reference substance name:

Chromium(3+) tri(pyridine-3-carboxylate)

IUPAC Name:

Chromium(3+) tri(pyridine-3-carboxylate)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

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 or test system and environmental conditions:

Five male rats and five nulliparous and non-pregnant female rats (body weight: 298–310 and 199–205 g, respectively) were received from Ace Animals, Inc., (Boyertown, PA, USA) and allowed free access to lab chow (Purina Rodent Chow No. 5012, St. Louis, MO, USA) and municipal water ad libitum. Animals were acclimated to laboratory conditions for 13 days prior to initiation of dosing. The animal room was kept at a controlled temperature (18–22 °C) and light (12 h light/12 h dark).

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

test product was moistened with distilled water to achieve a dry paste by preparing a 70% w/w mixture

Details on dermal exposure:

Individual doses of the NBC 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 NBC test product was moistened with distilled water to achieve a dry paste by preparing a 70% w/w mixture. The NBC was then applied to a 2 in. * 3 in., 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-in. Durapore tape to avoid dislocation of the pad and to minimize loss of the test substance.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

The day of application was considered Day 0 of the study. After 24 h of exposure to the test substance, the pads were removed and the test sites were gently cleansed of any residual test substance. Individual body weights of the animals were recorded prior to test substance application (initial) and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice. The animals were observed for mortality, signs of gross toxicity, and behavioral changes after application and at least once daily thereafter for 14 days. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma. All rats were euthanized via CO 2 inhalation on Day 14. Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.

Statistics:

no statistics applied due to absence of effects

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality was observed

Clinical signs:

other: no adverse clinical signs were observed, animals remained active and healthy

Gross pathology:

No gross abnormalities were noted for any of the animals at necropsy.

Other findings:

There were no signs of gross toxicity, dermal irritation, adverse pharmacologic effects or abnormal behavior.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal toxicity to rats was found as LD50 >2000 mg/kg bw. No mortality occured and no adverse effects were noted.

Executive summary:

In this acute dermal toxicity study using Sprague-Daley male and female rats, exposed to 2000 mg/kg bw did not show mortality, clinical signs of toxicity or pathological alterations upon gross necropsy. Body weight development also was not affected by treatment. Thus, the acute dermal LD50 was set to >2.000 mg/kg bw and the substance was considered not classified according to CLP (Regulation EC No 1272/2008).