Poly(polyalkylammonium) poly(µ-alkoxy)-µ6-oxido-polyhedropoly(chloridometal)ate polyalkanol solvate

Endpoint summary

Description of key information

The test item was given to female rats by oral administration to obtain information on the toxicity, in particular, lethality of a test item.

Under the present test conditions, a single oral administration of 2000 mg test substance to female rats did not reveal any signs of toxicity. No animal died prematurely. All animals gained the expected body weight. No pathological changes were observed at necropsy

Therefore, the test substance is n o n - t o x i c if swallowed, as LD50 > 2000 mg/kg b.w., p.o.

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:

2012-09-19 to 2012-10-16

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:

2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

(1998)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: Rattus norvegicus CD / Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS: 
- Source: Charles River Deutschland, Sulzfeld
- Strain: Rattus norvegicus CD / Crl: CD(SD)
- approx. 8 weeks
- body weight: 167 - 177 g
- Fasting period before study: 16 hours
- Diet: ad libitum, ssniff R/M-H V 1534
- Water: ad libitum
- Acclimatisation period: at least 5 days
- Temperature (°C): 22 °C +/- 3° C
- Humidity (%): 55% +/- 15 %
- Illumination: 12 hours artifical fluorescent light and 12 hours dark
- Air change: 12 to 18-fold/per hour

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

ADMINISTRATION: 
- Frequency: single dosage on day 1
- Dose volume: 10 ml/kg b.w.
- Dose: 2000 mg/kg/bw
- Vehicle: 0.8% aqueous hydroxypropylmethylcellulose
- DOSAGE PREPARATION: test item was suspended in 0.8% aqueous hydroxypropylmethylcellulose to the appropriate concentration.
The administration volume was 10 mL/kg b.w.
- CLASS METHOD: acute-toxic-class methode
first step 3 female rats are treated with 2000 mg/kg b.w., no signs of toxicity were observed
second step (after 24 h) 3 female rats are treated with 2000 mg/kg b.w.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: before administration, immediatly, 5, 10, 30 and 60 min, 3, 6 and 24 h after administration and at least once daily
thereafter, until day 14
- Body weight: days 0 (pre-administration) 7 and 14
- Necropsy: All survived animals were necropsied at the end of the observation period

Statistics:

not required

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No signs of toxicity.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

no other findings

no other information

Conclusions:

Under the present test conditions, the test item requires no labelling, as LD50 > 2000 mg/kg b.w., p.o.

Executive summary:

The test item was given to female rats by oral administration to obtain information on the toxicity, in particular, lethality of a test item

Under the present test conditions, a single oral administration of 2000 mg test substance to female rats did not reveal any signs of toxicity. No animal died prematurely. All animals gained the expected body weight. No pathological changes were observed at necropsy

Therefore, the test substance is n o n - t o x i c if swallowed, as LD50 > 2000 mg/kg b.w., p.o.

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

Justification for classification or non-classification

Based on the results of the acute oral toxicity study in rats and according to the criteria of EC Regulation 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, the test item has not to be classified.