Trichromium dicarbide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Study period:

From 25 August 1988 to 8 September 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Read-across to chromium(III) oxide. The release of chromium from chromium carbide is very similar to the release from chromium metal and chromium(III) oxide and therefore the results obtained with these substances can readily be used in the assessment of trichromium dicarbide. Acceptable, quite well-documented study report. Test comparable to guideline study (OECD 420) with some restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EU: 84/449/EWG

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

yes

Remarks:

(one (high) dose level used, both female and male rats used)

Principles of method if other than guideline:

One dose of test substance given to animals intragastrically in a volume of 10/20 (both values mentioned in protocol, unclear which is the correct one) ml/kg bodyweight. The animals were observed for clinical symptoms during 14 days, after which they were sacrificed.
The test method is comparable to OECD 420 guideline with some restrictions.

GLP compliance:

yes

Test type:

other:

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chromium(III) oxide

IUPAC Name:

Chromium(III) oxide

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wistar Rats (Strain Bor: WISW (SPF Opb) from Winckelmann, Borchen, Germany
- Age at study initiation: males: 9 weeks old, females: 14 weeks old
- Weight at study initiation: males 175 g, females 172 g
- Fasting period before study:
- Housing: Macrolon cages type III, wood granules from Firma Ssniff, Soest/Westfahlen, germany
- Diet (e.g. ad libitum): Standar diet AltrominR1324 (Altromin GmbH, Lage, Germany) ad libitum
- Water (e.g. ad libitum): yes, ad libitum
- Acclimation period: minumum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 degrees Celsius
- Humidity (%): 50±10% relative humidity
- Air changes (per hr): ca 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light


IN-LIFE DATES: 14 days after administration

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5000 mg/kg bodyweight females,. application volume 10 ml/kg or 20 ml/kg (both volumes mentioned in report, unclear which is the correct one), i.e. concentration in vehicle 500 mg/ml or 250 mg/ml
- Amount of vehicle (if gavage): application volume 10 ml/kg or 20 ml/kg (both volumes mentioned in report, unclear which is the correct one
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data


MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bodyweight females,. application volume 10 ml/kg or 20 ml/kg (both volumes mentioned in report, unclear which is the correct one), i.e. concentration in vehicle 500 mg/ml or 250 mg/ml





CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At the first day the animals were inspected numerous times, and after that twice per day (once at weekends and holidays).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs of toxicty, body weight, pathology-anatomy findings

Statistics:

LD50 calculated based on the method described by Rosiello et al (J. Tox. Environ. Health, 3, 797, 1977), modified by Pauluhn (Bayer AG, Bericht Nr. 11835, 1983). The calculations were based on the Maximum-likelihood-method by Bliss (J. Pharm. Pharmacol. 11, 192, 1938).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

None of the rats died during the 14 days observation period.

Clinical signs:

other: Salivation increased among all animals 15 minutes after administration of the test substance, and lasted about 8 hours. The furs of one male and one female rat were ruffled during 8 hours after the gavage.

Gross pathology:

No findings.

Other findings:

No effects were observed during the pathological anatomical examination.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

No deaths were observed after administration of 5000 mg/kg of the test compound, indicating a LD50 > 5000 mg/kg for chromium(III) oxide (corresponding to >3400 mg/kg Cr(III)).

Executive summary:

Five male (9 weeks old, starting weight 175 g) and five female (14 weeks old, starting weight 172 g) Wistar rats were given oral doses (intragastric) of 5000 mg/kg of chromium(III) oxide. None of the rats died during the 14 days observation period. The rats were killed at day 14. No effects were observed during the pathological anatomical examination, indicating an LD₅₀-value higher than 5000 mg/kg for chromium(III) oxide; corresponding to 3400 mg Cr(III)/kg bw.