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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Toxicity to birds

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not a GLP study but well described protocol
Qualifier:
no guideline followed
Principles of method if other than guideline:
A series of experiments was undertaken to further investigate the influence of diet composition on chick response to monensin supplementation. Experiments included dietary content of vanadium with broiler chicks to 4 weeks of age.
GLP compliance:
no
Dose method:
feed
Analytical monitoring:
no
Vehicle:
no
Details on preparation and analysis of diet:
DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: yes
- Preparation of doses: no data

HOMOGENEITY AND STABILITY OF TEST MATERIAL IN DIET
- How often was homogeneity and stability tested: no data
- When and at what dose levels were samples of treated food analyzed for stability and concentration during the study: no data
- Nominal concentration (mg/kg feed): 0, 5, 10 or 20 ppm V
Test organisms (species):
other: chicks
Details on test organisms:
TEST ORGANISM
- Common name: Hubbard chicks
- Age at test initiation: 1 day old
- Weight at test initiation: not given
- Sexes used: males
Limit test:
no
Total exposure duration (if not single dose):
4 wk
Post exposure observation period:
no data
No. of animals per sex per dose and/or stage:
4 replicates were used per dietary treatment
Control animals:
yes, plain diet
Nominal and measured doses / concentrations:
0, 5, 10 or 20 ppm V added
Details on test conditions:
ACCLIMATION; no detail

TEST CONDITIONS (range, mean, SD as applicable)
- Brooder temperature: electrically heated battery, no other detail
- Photoperiod: continuous artificial lighting program

Feed and water were offered ad libitum.
Details on examinations and observations:
MORTALITY / CLINICAL SIGNS: recorded daily

BODY WEIGHT: at beginning and the end of trial

FOOD CONSUMPTION: recorded weekly

OTHER: hepatic Rb and K were analysed from eight chicks per treatment.
Details on reproductive parameters:
not studied
Reference substance (positive control):
no
Duration (if not single dose):
4 wk
Dose descriptor:
NOEL
Effect level:
5 mg/kg diet
Conc. / dose based on:
element
Remarks:
vanadium
Basis for effect:
body weight
Duration (if not single dose):
4 wk
Dose descriptor:
LOEL
Effect level:
10 mg/kg diet
Conc. / dose based on:
element
Remarks:
vanadium
Basis for effect:
body weight

Supplementing the diet with 10 or 20 ppm vanadium significantly reduced mean body weight, feed intake and feed efficiency.

Based on the mean of 1116 g diet intake per chick within 4 weeks and due to the fact that no data is given on the body weight at one day old (only 703 g mean weight after 4 weeks), the corresponding NOEL could be calculated at 0.28 mg/kg bw/day.

Executive summary:

A series of experiments was undertaken to further investigate the influence of diet composition on chick response to the antibiotic monensin supplementation. These experiments included dietary supplementation with vanadium content of 0, 5, 10 or 20 ppm, given to male chicks from one day old during 4 weeks.

Supplementing the diet with 10 or 20 ppm vanadium significantly reduced mean body weight, feed intake and feed efficiency.

5 mg/kg diet was determined as a NOEL for this study.

Description of key information

Two entries were reported for toxicity to birds:

- The first one is a publication from Cervantes, 1985, where vanadium content of 0, 5, 10 or 20 ppm were given to male chicks from one day old during 4 weeks. Supplementing the diet with 10 or 20 ppm vanadium significantly reduced mean body weight, feed intake and feed efficiency. 5 mg/kg diet was determined as a NOEL for this study.

- The second one is a literature search completed according to the Eco-SSL guidance (U.S. EPA, 2003) which remained 36 papers containing data for avian test species. These papers were reviewed and data were extracted and scored according to the Eco-SSL guidance. Within the 36 reviewed papers, there were 132 results for biochemical, behavioural, physiology, pathology, reproduction, growth, and survival effects that had a Data Evaluation Score of >65 (sufficient to derive the Toxicity Reference Value).

The no-observed adverse effect (NOAEL) values for growth and reproduction are used to calculate a geometric mean NOAEL. A geometric mean of the NOAEL values for growth and reproduction was calculated at 1.19 mg vanadium/kg bw/day.

Toxicity to birds is not required for this dossier due to tonnage band, but were referenced for knowledge purpose and showed that it is not necessary to go ahead with testing.

Key value for chemical safety assessment

Additional information