Dimanganese trioxide

Endpoint summary

Description of key information

In an acute oral toxicity study conducted according to OECD guideline 423, six fasted female Wistar rats were given a single oral dose of 2000 mg/kg bw of the target substance dimanganese trioxide (99.9% purity). Animals were then observed for 14 days. No mortality and no adverse signs of toxicity were observed during the observation period. Based on the results, the oral LD50 in rats was established to exceed 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-07-12 to 2017-09-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 9-10 weeks
- Weight at study initiation: Step 1: 164 – 176 g, Step 2: 164 - 171 g
- Fasting period before study: 16 - 19 h
- Housing: - In groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Yes
- Water (e.g. ad libitum): Yes
- Acclimation period: at least five days

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

Route of administration:

oral: gavage

Vehicle:

other: Aqua ad injectionem

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: Vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no. (if required): 612118

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3 females per step, 2 steps

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Observed for 14 days after dosing for general clinical signs, morbidity and mortality
- Frequency of weighing: Yes, the animals were weighed on day 1 (prior to the administration) and on days 8 and 15
- Necropsy of survivors performed: Yes, 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.
- Other examinations performed: clinical signs: 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. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Statistics:

Not specified

Preliminary study:

Not specified

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality occurred at the limit dose of 2000 mg/kg bw

Mortality:

No mortality was observed in any of the test animals.

Clinical signs:

other: No test item related clinical signs were observed in any of the test animals.

Gross pathology:

No significant gross pathological changes were observed in any of the test animals.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results from an acute oral toxicity study, the LD50 of the test item was established to be greater than 2000 mg/kg body weight.

Executive summary:

In an acute oral toxicity study conducted according to OECD guideline 423, six fasted female Wistar rats were given a single oral dose of the test item (99.9% purity), suspended in distilled water, at a dose of 2000 mg/kg bw (limit test) and were observed afterwards for 14 days. Neither mortality nor adverse signs of toxicity were recorded during the observation period. Based on the results from this study, the oral LD50 in rats was established to be greater than 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an acute oral toxicity study conducted according to OECD guideline 423, six fasted female Wistar rats were given a single oral dose of 2000 mg/kg bw of the target substance dimanganese trioxide (99.9% purity). Animals were then observed for 14 days. No mortality and no adverse signs of toxicity were observed during the observation period. Based on the results, the oral LD50 in rats was established to exceed 2000 mg/kg bw.

Justification for classification or non-classification

Based on the available data, dimanganese trioxide does not warrant classification for acute toxicity. The LD50 value for the oral route is above the limit value of the relevant OECD guideline.