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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1 July 1993 to 11 August 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

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

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 temperature 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. 8-10 weeks
- Weight at study initiation: Body weight at start of treatment within ± 20% of the sex mean
- Housing: Individually housed 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 Klingentalmuhle AG, Kaiseraugst, Switzerland)
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: Acclimatisation period was 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

Administration / exposure

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: 25cm2 for males and 18cm2 for females.
- Type of wrap if used: Flexible bandage (Coban, 3M, St. Paul, U.S.A.)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance were removed with tissue moistened with tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Group 1: 2 ml/kg body weight. Group 2: 4 ml/kg body weight

Duration of exposure:

24 hours

Doses:

Group 1: 1000 mg/kg body weight.
Group 2: 2000 mg/kg body weight

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality/Viability recorded twice daily. Body weights recoded on Days 1 (pre—administration), 8 and 15.
- Necropsy of survivors performed: All animals surviving to the end of the observation period (day 15) were sacrificed by oxygen/carbon dioxide asphyxiation. All animals assigned to the study were subjected to necropsy and descriptions of all macroscopic abnormalities recorded.
- Other examinations performed: clinical signs recorded at periodic intervals on the day of treatment (day 1) 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
Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No clinical signs of ill health or behavioural changes were observed during the study period. Abnormalities on the treated skin area noted among theanimals included erythema (noted between days 2 and 15), scales (noted between days 4 and 15) and scabs (be

Gross pathology:

Macroscopic post mortem examination of the animals at termination revealed scab formation on the treated skin area in one male and one female exposed at 1000 mg/kg and reddish colouration and scab formation on the treated skin area of three females exposed at 2000 mg/kg

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 values of the test substance in rats of either sex was established as exceeding 2000 mg/kg body weight

Executive summary:

In a GLP compliant, guideline acute dermal toxicity test the dermal LD50 values of the test substance in rats of either sex was 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 test substance cannot be classified and has no obligatory labelling requirement.