Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb 3rd - Mar 3rd, 1987
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: other guideline : 28 days of tube feeding according the EPA (40 CFR parts 160 and 792)
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
419-690-3
EC Name:
-
Cas Number:
88020-55-7
Molecular formula:
[(C12H25)3NH]4Mo8O26
IUPAC Name:
tridodecylamine hydrate molybdenum

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days
Frequency of treatment:
7 days/week
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
10 mg/kg/day
Basis:
no data
Remarks:
Doses / Concentrations:
50 mg/kg/day
Basis:
no data
Remarks:
Doses / Concentrations:
250 mg/kg/day
Basis:
no data
No. of animals per sex per dose:
Male : 5 animals at 0 mg/kg bw/day
Male : 5 animals at 10 mg/kg bw/day
Male : 5 animals at 50 mg/kg bw/day
Male : 5 animals at 250 mg/kg bw/day
Female : 5 animals at 0 mg/kg bw/day
Female : 5 animals at 10 mg/kg bw/day
Female : 5 animals at 50 mg/kg bw/day
Female : 5 animals at 250 mg/kg bw/day
Control animals:
yes, concurrent vehicle

Results and discussion

Results of examinations

Details on results:
Clinical observations :
no mortality linked to the substance ; accidental deaths occured in the test group and in the treated groups for 10 and 250 mg/kg/j.
No clinical signs, except those resulting from tube feeding mistakes.
Reduction of food consumption (males, week 2) and of corporal weight (males, week 2,3, and 4) : group 4

Laboratory findings :
statistically no significant difference of the different haematological parameters.
On biological plan, increase of creatinine for the males of the group 4 ; we observed for few males from group 3, an increase of ASAT, and for males from group 3&4, of ALAT.
No other significant anomaly on toxicological plan.

Effects on organs : for the males from the group4 :
- increase of the brain relative weight, and surrenals,
- decrease of liver absolute weight.
Regarding the histological examination, moderate damage of the epithelium of the renal tubules (cortical tubular hyperplasia) for the males and 4 females from the group 4.

Effect levels

Dose descriptor:
NOAEL
Effect level:
50 mg/kg bw/day (actual dose received)

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Laboratory observations:

A slight increase in blood urea nitrogen and aspartate and alanine transferases at 250 mg/kg/day.

Effects on bodies :

Mild to marked regenerative hyperplasia of the epithelium of the cortical tubules of the kidney at 250 mg/kg/day

Applicant's summary and conclusion

Conclusions:
NOAEL = 50 mg/kg bw/day