Spinels, chromium iron manganese brown

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2021-10-04 to 2021-10-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001-12-17

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2019-11-29.

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Spinels, chromium iron manganese brown

EC Number:

271-411-2

EC Name:

Spinels, chromium iron manganese brown

Cas Number:

68555-06-6

Molecular formula:

(Mn, Fe)(Mn, Fe, Cr)2O4

IUPAC Name:

oxo[(oxochromio)oxy]chromium; oxo[(oxoferrio)oxy]iron; oxo[(oxomanganio)oxy]manganese

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material: Spinels, chromium iron manganese brown
- C.I. name: Pigment Brown 46
- Substance type: inorganic pigment
- Physical state:solid, black powder, odourless
- Storage condition of test material: at room temperature, keep dry in closed containers

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature and keep dry in closed containers.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI(Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 9 weeks old
- Weight at study initiation: 148 - 166 g
- Fasting period before study: 17.5 - 18 hours
- Housing: animals were kept in groups of three animals in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding.
- Diet (ad libitum): Altromin 1324 maintenance diet for rats and mice (manufacturer: Altromin Spezialfutter GmbH & Co. KG, Lage, Germany)
- Water (ad libitum): tap water, sulphur acidified to a pH value of approximately 2.8
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10 times
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

sterile

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2.5 g/5 mL
- Justification for choice of vehicle: based on the outcome of the solubility test. The vehicle was chosen due to its non-toxic characteristics.
- Lot no.: 2005066

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSIGE PREPARATION:
The test item was suspended with the vehicle. Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before each dose administration.

CLASS METHOD
- Rationale for the selection of the starting dose: A dose of 5000 mg/kg bw has been selected for the following reasons: the study will be used for EU countries implementing the CLP regulation as well as for non-EU countries implementing the GHS regulation. Furthermore, the test item shows a low water solubility. As the bioavailability (and thus solubility) of the test item is a key determinant of toxicity, low toxicity is expected, therefore justifying an initial testing at the limit dose of 5000 mg/kg bw.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: a careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. Observations on mortality/morbidity were made at least once daily.
Animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were sacrificed and all animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In the absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation.

Statistics:

No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).

Results and discussion

Preliminary study:

No

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

The test item showed no mortality.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

None of the animals showed weight loss during the observation period. Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain.

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (female rats) > 5000 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.