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Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 May 1993 to 11 June 1993
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
EC B.1
according to guideline
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)
EC Number:
EC Name:
Reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)
Cas Number:
Molecular formula:
A complex mixture of species so no unique molecular formula can be given
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

Details on test animals or test system and environmental conditions:
- 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.

- 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
polyethylene glycol
Details on oral exposure:
Dose concentration: 4 ml/kg body weight
2000 mg/kg body weight
No. of animals per sex per dose:
Control animals:
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.
Not applicable

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
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
Migrated information Criteria used for interpretation of results: EU
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.