Registration Dossier

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Well-documented publication. However, the study design does not meet important criteria of today standard methods.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
other:
Title:
Effects of copper sulfate, copper sulfide and sodium sulfide on performance and copper stores of pigs.
Author:
Cromwell, G.L.
Year:
1979
Bibliographic source:
J. Animal Sci. 46, 692-698

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Yorkshire pigs were treated with 225 or 450 ppm sodium sulfide in the diet for 104 days in a feeding study. The diets were prepared with three levels of Cu (0, 125 and 250 ppm) as CuSO4 in combination with three levels of Na2S (0, 225 or 450 ppm).
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium sulphide
EC Number:
215-211-5
EC Name:
Disodium sulphide
Cas Number:
1313-82-2
Molecular formula:
Na2S
IUPAC Name:
disodium sulfide
Details on test material:
- Name of test material (as cited in study report): sodium sulfide

Test animals

Species:
pig
Strain:
other: Yorkshire
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 55.5 days old
- Weight at study initiation: 15.7 kg (average weight)

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: feed
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
104 days
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
225 ppm
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
450 ppm
Basis:
nominal in diet
No. of animals per sex per dose:
144 animals (total); 4 replicates of 4 per pen
Control animals:
yes

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data

FOOD EFFICIENCY: yes

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: Yes
- Parameters checked: haemoglobin, hematocrit

CLINICAL CHEMISTRY: No data

URINALYSIS: No data

NEUROBEHAVIOURAL EXAMINATION: No data

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
BODY WEIGHT AND WEIGHT GAIN
Addition of sulfide did not affect rate or efficiency of weight gains.

FOOD EFFICIENCY
Addition of sulfide did not affect food efficiency.

HAEMATOLOGY
Haemoglobin and hematocrit values were not influenced by the levels of dietary sulfide.

Effect levels

Dose descriptor:
NOAEL
Basis for effect level:
other: see 'Remark'
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No NOAEL could be derived. Addition of sulfide did not affect rate or efficiency of weight gains and food efficiency, and haemoglobin and hematocrit values were not influenced by the level of dietary sulfide.