Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 January 1996 to 15 April 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Limit test
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(C11-14-branched and linear alkyl)dithiocarbamic acid
Molecular formula:
N/A
IUPAC Name:
Bis(C11-14-branched and linear alkyl)dithiocarbamic acid
Constituent 2
Chemical structure
Reference substance name:
Molybdenum, bis(C11-14 branched and linear alkyl)carbamodithioato-.kappa.S,.kappa.S')oxodi-thioxothioxodi-
Molecular formula:
N/A
IUPAC Name:
Molybdenum, bis(C11-14 branched and linear alkyl)carbamodithioato-.kappa.S,.kappa.S')oxodi-thioxothioxodi-
Constituent 3
Chemical structure
Reference substance name:
Molybdenum, bis(C11-14 branched and linear alkyl)carbamodithioato-.kappa.S,.kappa.S')dioxodi-thioxodi-
Molecular formula:
N/A
IUPAC Name:
Molybdenum, bis(C11-14 branched and linear alkyl)carbamodithioato-.kappa.S,.kappa.S')dioxodi-thioxodi-
Constituent 4
Chemical structure
Reference substance name:
Molybdenum, bis(N,N-di-C11-14 branched and linear alkyl)carbamodithioato-.kappa.S,.kappa.S')-oxodioxo-thioxodi-
Molecular formula:
N/A
IUPAC Name:
Molybdenum, bis(N,N-di-C11-14 branched and linear alkyl)carbamodithioato-.kappa.S,.kappa.S')-oxodioxo-thioxodi-
Test material form:
liquid
Specific details on test material used for the study:
- Description: Dark brown very viscous liquid
- Storage: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
Crl: CD(R)BR VAF/Plus(R)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage, Michigan
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult
- Weight at study initiation: approximately 200 - 300 g
- Fasting period before study: Overnight
- Housing: The animals were housed individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Rodent Chow #5002 (purina Mills, Inc.) was provided ad libitum to the animals throughout the study (except during fasting)
- Water (e.g. ad libitum): Municipal tap water following treatment by reverse osmosis was available ad mibitum throughout the study
- Acclimation period: Minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ~22
- Humidity (%): ~55
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The test material was mixed with corn oil to produce a 50% w/v concentration for dose administration.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Preliminary study:
No mortality occurred during the limit test
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
no deaths reported at this dose level
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
One female had incidenses of decreased activity, soft stools, urine/fecal staining, and rales.
Body weight:
Normal weight gain
Gross pathology:
No gross findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the acute oral LD50 was estimated to be greater than 2000 mg/kg in the rat.
Executive summary:

The single-dose oral toxicity of the test material was evaluated in Sprague-Dawley rats in a study performed to the standardised guideline OECD 401 under GLP conditions. A limit test was performed in which one group of five male and five female rats received a single oral administration of the test material at a dose level of 2000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at !he time of scheduled euthanasia (day 14).

 

No mortality occurred during the limit test. Clinical abnormalities noted during the study were observed in one female and consisted of incidences of decreased activity, soft stools, urine/faecal  staining and rales. Body weight gain was normal for all animals during the test period. No gross internal findings were observed at necropsy on study day 14.

 

Under the conditions of this test, the acute oral LD50 of the test material was estimated to be greater than 2000 mg/kg in the rat.