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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The group size is not defined, an thus the study and its statistical basis cannot be evaluated

Data source

Reference
Reference Type:
publication
Title:
Effects of chronic manganese (Mn3O4) exposure on selected reproductive parameters in rats
Author:
Laskey JW, Rehnberg GL, Hein JF & Carter SD
Year:
1982
Bibliographic source:
Journal of Toxicology and Environmental Health, 9: 677-687

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Long-Evans rats were chronically exposed to Mn3O4 (in diet) at 0, 350, 1050 and 3500 ppm from day 1 of gestation up to 224 days of age. Rats were grouped into either low or normal Fe dietary levels. Reproductive development and fertility of the F1 generation were determined.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Silicomanganese manufacturing fumes dedusting solid residues
EC Number:
930-776-4
IUPAC Name:
Silicomanganese manufacturing fumes dedusting solid residues
Details on test material:
- Name of test material : Mn3O4 (trimanganese tetraoxide)
- Analytical purity: 98 %

Test animals

Species:
rat
Strain:
Long-Evans

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
- Impregnation procedure: co-housed
- If co-housed:
- M/F ratio per cage: 1:2
- Length of cohabitation: 2 weeks
Duration of treatment / exposure:
Pregnant females were exposed to Mn3O4 in diet from day 2 of pregnancy until weaning of the offspring. Offspring were further exposed and mated at day 90-100. Treatment continued until the end of the study, 224 days.
Frequency of treatment:
Daily
Duration of test:
Up to 224 days of age
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 350, 1050 and 3500 ppm
Basis:
nominal conc.
No. of animals per sex per dose:
Not reported
Control animals:
yes, plain diet

Results and discussion

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

General toxic effects were apparent in young animals at a dietary dose of 3500 ppm Mn and were enhanced by concomitant Fe deficiency. Fertility was reduced in the group exposed to 3500 ppm Mn with a diet containing sufficient Fe. Male reproductive development was delayed by Mn treatment, as measured by testes weight, sperm count, and serum follicle-stimulating hormone and testosterone concentrations.

Applicant's summary and conclusion

Conclusions:
The study cannot be evaluated as no information on group size is given, and thus validity of the statistics cannot be guaranteed.