Registration Dossier

Ecotoxicological information

Toxicity to other above-ground organisms

Administrative data

Endpoint:
toxicity to other above-ground organisms
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No guideline study, but study was conducted in a scientifically correct way, and data are useful for the evaluation of Ba-toxicity via oral exposure
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Original report not available: mice and rats were fed barium via drinking water for 13wk and 2y.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Sampling and analysis

Analytical monitoring:
not specified
Details on sampling:
not reported in Dallas and Williams, 2001

Test organisms

Test organisms (species):
other: rats and mice
Details on test organisms:
not reported in Dallas and Williams, 2001

Study design

Study type:
laboratory study
Limit test:
no
Total exposure duration:
104 wk

Test conditions

Test temperature:
not reported in Dallas and Williams, 2001
Details on test conditions:
not reported in Dallas and Williams, 2001
Nominal and measured concentrations:
not reported in Dallas and Williams, 2001

Results and discussion

Effect concentrationsopen allclose all
Duration:
13 wk
Dose descriptor:
other: NOAEL
Effect conc.:
2 000 other: ppm barium chloride dihydrate
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Remarks on result:
other: data for rats and mice
Duration:
104 wk
Dose descriptor:
other: NOAEL
Effect conc.:
60 other: mg/kg/d
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: neoplasms or nonneoplastic lesions
Remarks on result:
other: male rat
Duration:
104 wk
Dose descriptor:
other: NOAEL
Effect conc.:
75 other: mg/kg/d
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: neoplasms or nonneoplastic lesions
Remarks on result:
other: female rat
Duration:
104 wk
Dose descriptor:
other: NOAEL
Effect conc.:
75 other: mg/kg/d
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: kidneys, nephropathy, renal tubule regeneration, lymphoid depletions
Remarks on result:
other: male mice
Duration:
104 wk
Dose descriptor:
other: NOAEL
Effect conc.:
90 other: mg/kg/d
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: kidneys, nephropathy, renal tubule regeneration, lymphoid depletions
Remarks on result:
other: female mice
Details on results:
The main findings of the long-term exposures (13 wk, 2 yr) are summarized hereunder:
- I3 wk study: It was concluded from the neurobehavioural data that there were no consistent effects on behaviour produced by Ba exposure. The No-observed-adverse-effect-level (NOAEL) for this subchronic study was considered to be 2000 ppm Ba chloride dihydrate; this corresponds to 110 mg Ba/kg/d for male rats, 115 mg Ba/kg/d for female rats, 205 mg Ba/kg/d for male mice, and 200 mg Ba/kg/d for female mice. These data were also reported by Dietz et al (1992).
- 13 wk study: Death in mice in the highest dose groups (450 mg Ba/kg/d for males and 495 mg Ba/kg/d for females) were associated with renal toxicity. Renal lesions in rats were much less severe at the highest dose level (200 mg Ba/kg/d for males and 180 mg Ba/kg/d for females).
- In the 2yr study, the evaluated endpoints were hematology values and increases in neoplasms; the conclusion was “no increased incidences of neoplasms or nonneoplastic lesions that could be attributed to BaCl2 dihydrate” for rats receiving average dose rates of 60 (male) and 75 (female) mg/kg/d.
- For mice (endpoints were kidneys, nephropathy, renal tubule regeneration, lymphoid depletions) the identified NOAEL was 75 mg Ba/kg/d for males, and 90 mg Ba/kg/d for females.

Applicant's summary and conclusion

Conclusions:
Data can be used in a weight of evidence approach for the derivation of a PNECoral (secondary poisoning)