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

Endpoint summary

Description of key information

Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, GLP study)

Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, GLP study)

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:

26 May 1993 to 11 June 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

EC B.1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP compliant guideline acute oral study with a klimisch score of 1

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP compliant guideline acute dermal study with a klimisch score of 1

Additional information

Acute toxicity studies to OECD protocols and to acceptable quality standards show no toxicity to rats via the oral and dermal routes when tested to limit test values of 2000mg/kg bw. 

Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for selection of acute toxicity – dermal endpoint

Only one study available

Justification for classification or non-classification

Acute oral toxicity:

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.

Acute dermal toxicity:

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.