Reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 May 1993 to 11 June 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

EC B.1

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)

EC Number:

412-780-3

EC Name:

Reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)

Cas Number:

1380226-46-9

Molecular formula:

A complex mixture of species so no unique molecular formula can be given

IUPAC Name:

dimolybdenum(6+) diammonium 2-{2-[(octadec-9-en-1-yl)amino]ethoxy}ethan-1-ol heptaoxidandiide

Test material form:

liquid: viscous

Details on test material:

- Name of test material: Additiv 104 - Konzentrat
- Description: Dark red liquid
- Purity: Product by process; treated as 100% pure.
- Lot/batch No.: DS 147
- Expiration date of the lot/batch: March 9, 1994
- Stability under storage conditions and up to 60 degrees C: Stable
- Storage condition of test material: Room termperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: Approx. 9 weeks
- Weight at study initiation: Within +/- 20% of the sex mean.
- Fasting period before study: Overnight
- Housing: Group housing of 5 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle AG, Kaiseraugst, Switzerland)
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: at least 5 days before start of' treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): relative humidity of 55%.
- Air changes (per hr): The room was air-conditioned with 15 air changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.

IN-LIFE DATES: From: To: 26 May 1993- 11 June 1993

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

None

Details on oral exposure:

Dose concentration: 4 ml/kg body weight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 17 days
- Frequency of observations and weighing: Mortality and viability observations carried out twice daily, bodyweights recorded on Days 1 (pre-administration), 8, 15 and 17.
- Necropsy of survivors performed: All animals surviving to the end of the observation period (day 17) were sacrificed by oxygen/carbon dioxide asphyxiation. All animals assigned to the study were subjected to necropsy and descriptions of all macroscopic abnormalitiesrecorded
- Other examinations performed: clinical signs recorded at periodic intervals on the day of dosing (day1) and once daily thereafter. The time of onset,
degree and duration were recorded.

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No clinical signs were noted with exception of alopecia which was noted in three females at various times during the study period.

Gross pathology:

Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities that were not commonly noted among rats of this age and strain.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 values of the test substance in rats of the sexes combined, males alone and females alone were established as exceeding 2000
mg/kg body weight.

Executive summary:

In a GLP compliant, guideline acute oral toxicity test the oral LD50 values of the test substance in rats of the sexes combined, males alone and females alone were established as exceeding 2000 mg/kg body weight. Based on these results and according to the EEC criteria for classification and labelling requirements for dangerous substances and preparations (EEC Directive 91/325/EEC, Amendment to Annex VI of the EEC Directive 67/548/EEC), the the substance cannot be classified and has no obligatory labelling requirement.