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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Toxicity to birds

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to birds
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Not sufficient information presented on methods and results.
Justification for type of information:
Please see read-across justification attached below.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eight weeks dietary toxicity study with leghorn hens.
GLP compliance:
not specified
Dose method:
feed
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
other: Gallus gallus domesticus
Details on test organisms:
single comb white leghorn hens, 22 weeks old.
Limit test:
no
Total exposure duration (if not single dose):
8 wk
No. of animals per sex per dose and/or stage:
not reported
Nominal and measured doses / concentrations:
nominal added doses: 1-10-100-1000 mg Bi/kg food.
Details on test conditions:
Groups of four, individually caged hens were fed a practical corn-soy laying mash supplemented with 4 increasing levels of the test material.
Details on examinations and observations:
individual feed intake was recorded weekly, body weigh bi-weekly
Details on reproductive parameters:
Egg production was recorded daily. Each bird was artificially inseminated twice weekly.
Reference substance (positive control):
not specified
Duration (if not single dose):
8 wk
Dose descriptor:
NOEC
Effect level:
>= 1 000 mg/kg diet
Conc. / dose based on:
element
Remarks:
Bi
Basis for effect:
reproductive parameters
Remarks:
egg production
Duration (if not single dose):
8 wk
Dose descriptor:
NOEC
Effect level:
>= 1 000 mg/kg diet
Conc. / dose based on:
element
Remarks:
Bi
Basis for effect:
mean feed consumption
Duration (if not single dose):
8 wk
Dose descriptor:
NOEC
Effect level:
>= 1 000 mg/kg diet
Conc. / dose based on:
element
Remarks:
Bi
Basis for effect:
body weight
Reported statistics and error estimates:
no information is given on statistics
Validity criteria fulfilled:
not specified
Conclusions:
Not sufficient information presented on methods and results; study is however used as weight of evidence.

Description of key information

In one dietary toxicity study with Leghorn hens fed with a corn-soy laying mash supplemented with read-across substance, dibismuth trioxide, NOEC values of ≥1000 mg bismuth/kg diet were reported for egg production.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for birds:
1 000 mg/kg food

Additional information

Only one dietary toxicity study with Leghorn hens was identified, reporting NOEC values of ≥1000 mg bismuth/kg diet for egg production, individual feed intake and body weight change after 8 weeks feeding with a corn-soy laying mash supplemented with read-across substance, dibismuth trioxide (Hermayer et al., 1977). This study was judged not assignable (Klimisch 4) because of the lack of information on both methods and results. However, the results were used in a weight-of-evidence approach indicating the limited risk for chronic dietary toxicity of bismuth metal and bismuth compounds.

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