Molybdenum, bis(N,N-dibutylcarbamodithioato-κS,κS')dioxodi-μ-thioxodi-, stereoisomer

Endpoint summary

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx 8 weeks
- Weight at study initiation: 141-184 g
- Fasting period before study: overnight fasting before dosing
- Housing: group housing of 3 animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:at least 5 days before dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 43-51
- Air changes (per hr): >= 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation was twice daily, weighing on Days 1, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

other: hunched posture, uncoordinated movements and/or piloerection were noted on days 1 and/or 2

Gross pathology:

no abnormalities

Interpretation of results:

other: substance has not to be classified according to Regulation 1272/2008

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

2009

GLP compliance:

yes

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 268-300 (males), 203-228 g (females)
- Fasting period before study: no
- Housing: group housing up to 5 animals per cage and sex
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 49-54
- Air changes (per hr): >=
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

ca. 4.3 µm

Geometric standard deviation (GSD):

ca. 2.2

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: directed flow nose only inhalation chamber
- Exposure chamber volume:
- Method of holding animals in test chamber: restraining tubes
- Source and rate of air: approx. 1 l/min at each animal port
- Method of conditioning air:
- System of generating particulates/aerosols: Wright dust feeder
- Method of particle size determination: 8 stage Marple personal cascade impactor; collected dust fraction was determined gravimetrically
- Treatment of exhaust air: passed through a filter
- Temperature, humidity, pressure in air chamber: 20.1-21.6°C, 10-12%

TEST ATMOSPHERE
- Brief description of analytical method used:
- Samples taken from breathing zone: yes/no

VEHICLE
- Composition of vehicle (if applicable):
- Concentration of test material in vehicle (if applicable):
- Justification of choice of vehicle:
- Lot/batch no. (if required):
- Purity:

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 0.5 µm - approx. 10 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 4.3 µm, GSD 2.2

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration:

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 4 h

Concentrations:

5.0 +/- 0.1 mg/l

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation, weighing on days 1, 2, 4, 8, 15
- Necropsy of survivors performed: yes, macroscopic
- Other examinations performed: clinical signs, body weight

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

>= 5 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

no

Clinical signs:

other: after exposure, hunched posture and yellow staining (general) were seen for all animals between Days 1 and 4.

Body weight:

body weight loss was noted for all animals, this continued for three females up to Day 8, the animals regained weight during the second week.

Gross pathology:

no abnormalities observed

Interpretation of results:

other: no death at limit concentration

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In the acute oral toxicity study no animal died after a single dose at a level of 2000 mg/kg body weight. The substance is a fine powder and an inhalation study for acute toxicicty has been performed indicating no toxicity at the limit dose of 5 mg/l. In the absence of acute systemic toxicity after a single oral dose at the limit dose and based on the physical-chemical properties of the substance limiting skin penetration no acute dermal toxicity is to be expected.

Accordingly, the substance does not need to be classified for acute toxicity according to Regulation 1272/2008.