bis[C11-14-(branched and linear)-alkyl]aminium nonadecaoxohexatungstate

Endpoint summary

Description of key information

The oral LD50 (rat)  for bis[C11-14-(branched and linear)-alkyl]aminium nonadecaoxohexatungstate (EC 700-718-0), based upon results from the surrogate substance is greater than 2000 mg/kg bodyweight. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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:

20.12.2011 - 4.4.2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conducted according to OECD Guideline under GLP conditions.

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes

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 system
Species: Rat, Wistar strain Crl:WI (Han) (outbred, SPF -Quality).
Source: Charles River Deutschland, Sulzfed, Germany.
Identification: Ear and tailmark.
Health inspection: A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health.

Conditions
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 +/- 3.0 degrees Centigrade (actual range: 19.8 – 23.2 degrees Centigrade), a relative humidity of 40-70% (actual range: 38 – 66%) and 12 hours artificial fluorescent light and 12 hours darkness per day.

Accommodation
Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions.

Diet
Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).

Water
Free access to tap water.
Results of analysis for diet (nutrients and contaminants), sawdust, paper and water were assessed and did not reveal any findings that were considered to have affected the study integrity.

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Method: Oral gavage, using plastic feeding tubes.
Fasting: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
Frequency: Single dosage on Day 1.

Doses:

Dose level (volume): 2000 mg/kg (10 mL/kg) body weight.

No. of animals per sex per dose:

Each dose group consisted of 3 animals.

Control animals:

not specified

Details on study design:

The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

One animal showed piloerection on Day 1. No clinical signs of toxicity were noted In the other animals.

Body weight:

The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.

Gross pathology:

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

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an OECD 423 study (acute toxic class method), conducted according to GLP, the oral LD50 (rat) of reaction mass of bis(C11-14-alkyl, branched and linear)amine nonadecaoxo hexatungstate (the surrogate substance) was established to exceed 2000 mg/kg bodyweight. The LD50 (rat) cut-off value was considered to exceed 5000 mg/kg bodyweight (Notox B.V., 2012).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

1

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

Acute Oral Toxicity

key Study:

In an OECD 423 study (acute toxic class method), conducted according to GLP, the oral LD50 (rat) of reaction mass of bis(C11-14-alkyl, branched and linear)amine nonadecaoxo hexatungstate (the surrogate substance) is greater than 2000 mg/kg bodyweight. The LD50 (rat) cut-off value is greater than 5000 mg/kg bodyweight (Notox B.V., 2012).

Justification for selection of acute toxicity – oral endpoint
OECD Guideline study, conducted to GLP.

Justification for classification or non-classification

The oral LD50 value in Wistar rats is greater than 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value is greater than 5000 mg/kg body weight. No other effects or adverse symptoms were observed in the study.

Therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures the substance is not classified.