Table A.1.
Results of the RoB evaluation
| RefID | Authors and year | Study type | Random sequence generation (selection bias) | Allocation concealment (selection bias) | Experimental conditions (Performance bias) | Blinding of research personnel (performance bias) | Incomplete outcome data (attrition bias) | Confidence in exposure characterisation (detection bias) | Confidence in outcome assessment (detection bias) | Selective reporting (reporting bias) | Appropriateness of statistical methods (other source of bias) | Tier (based on rules) | Tier (agreement with automatically generated Tier) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 339 | Western Regional Research Laboratory (1965) (a) (Documentation provided to EFSA nr: 10) | Sub‐chronic toxicity | − | − | − | − | + | −− | − | + | − | 3 | Yes |
| + | + | −− | |||||||||||
| 307 | T.N.O. (1986) (Documentation provided to EFSA nr: 9) (b) | Sub‐chronic toxicity | ++ | ++ | ++ | ++ | ++ | ++ | ++ | ++ | ++ | 1 | Yes |
| + | |||||||||||||
| 286 | Gumbmann et al. (1978) (Documentation provided to EFSA nr: 9) | Sub‐chronic toxicity | − | −− | − | − | + | − | + | + | − | 3 | Yes |
| − | + | − | |||||||||||
| 360 | Shi et al. (2021) | Sub‐chronic toxicity | + | + | ++ | + | − | + | − | ++ | ++ | 2 | Yes |
| − | + | ||||||||||||
| 286 | Gumbmann et al. (1978) (Documentation provided to EFSA nr: 9) | Chronic toxicity (1‐year rat) | − | − | − | + (c) | − | − | − | − | − | 3 | Yes |
| 286 | Gumbmann et al. (1978) (Documentation provided to EFSA nr: 9) | Chronic toxicity (2‐year rat) | − | + | − | + | + | − | − | − | − | 3 | Yes |
| − | + | + | |||||||||||
| 286 | Gumbmann et al. (1978) (Documentation provided to EFSA nr: 9) | Chronic toxicity (2‐year dog) | − | − | − | + | − | − | − | − | − | 3 | Yes |
| 230 | Waalkens‐Berendsen et al. (2004) | Prenatal developmental toxicity | + | + | + | + | + | ++ | + | + | ++ | 1 | Yes |
| ++ | ++ | ++ | ++ | ++ | |||||||||
| 286 | Gumbmann et al. (1978) (Documentation provided to EFSA nr: 9) | Reproductive and developmental toxicity | − | + | + | + | + | − | − | −− | − | 3 | Yes |
| − | − | + | − | −− | |||||||||
| 339 | Western Regional Research Laboratory (1965) (Documentation provided to EFSA nr: 10) | Reproductive toxicity | − | + | − | + | − | −− | − | − | −− | 3 | Yes |
| + | − | ++ | + |
Definitely low risk of bias (++), Probably low risk of bias (+), Probably high risk of bias (−), Definitely high risk of bias (−−).
Split cells reporting two different scorings for the same risk of bias question express the view of the two independent reviewers.
Study on which the derivation of the current acceptable daily intake (ADI) was based (SCF, 1989).
This unpublished study report was subsequently published as Lina BAR, Dreef‐van der Meulen HC, Leegwater DC, 1990. Subchronic (13‐week) oral toxicity of neohesperidin dihydrochalcone in rats. Food Chemistry and Toxicology, 26(7), 507–513. https://doi.org/10.1016/0278-6915(90)90121-3.
This question was cloned for a specific endpoint (preparation of organs for weighing) and scored, by the two reviewers, as a probably high risk of bias (−). The tier allocation for this study, related to this specific endpoint, was also tier 3.