Chromium (III) oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25/8/1988-8/9/1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chromium (III) oxide

EC Number:

215-160-9

EC Name:

Chromium (III) oxide

Cas Number:

1308-38-9

Molecular formula:

Cr2O3

IUPAC Name:

chromium (III) oxide

Test material form:

solid: particulate/powder

Details on test material:

The test material: Chromoxyd Dyko
- State of aggregation: green powder
- pH: 7 - 8

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: storage at room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Females nulliparous and non-pregnant: yes
- Age at study initiation: males: ca. 9 weeks; females ca. 14 weeks
- Weight at study initiation(mean): males: 175 g: females: 172 g
- Fasting period before study: ca. 16 hours before test item administration and up to 4 hours after test item administration food was withdrawn.
- Housing: five animals/cage; Macrolon cage Typ III with dustfree wood pelletes (manufacturer: Firma Ssniff, Soest/Westfalen)
- Diet (ad libitum, for exception please refer to "Fasting period before study" above): "fixed-formula"- standard diet AltrominR1324 pellets (Manufacturer: Altromin GmbH, Lage)
- Water (ad libitum): drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Relative humidity: 50 ± 10 %
- Air changes: ca. 10 air changes/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

DOSAGE PREPARATION:
The test material was suspended in water at room temperature. The test material was formulated prior to administration. A homogeneous mixture was accomplished by stirring.
Animals were dosed using a constant application volume of 20 mL/kg bw.
The application volume was calculated based in the individual body weight of the animals determined prior to test item application.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males / 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on the day of the application, the animals were inspected several times and during the following 14-day observation period twice a day (once on weekends and holidays). The type, onset, duration and intensity of the clinical symptoms were recorded and any dead animals were removed. The time of death was recorded. At the end of the experiment animals were randomly selected for necropsy.
At application day, day 7 and at the end of the 14-day observation period, the surviving animals were individually weighed.
- Necropsy performed: yes, all deceased and surviving animals were macroscopically examined..

Statistics:

Statistical analysis not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: Clinical signs were limited to piloerection (one male and one female) and salivation (all animals) starting 15 minutes following dosing; signs had resolved within 8 hours.

Gross pathology:

There were no findings attributable to treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (male rats) > 5000 mg/kg
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.