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. Author manuscript; available in PMC: 2020 Oct 1.
Published in final edited form as: Regul Toxicol Pharmacol. 2019 Jun 11;107:104403. doi: 10.1016/j.yrtph.2019.104403

Table 4.

Relevant fields to document for an in vitro assay. Example: bacterial mutation assay

Compound identifier: CASRN: 462–06-6; Fluorobenzene; Benzene, fluoro-
Compound purity: Not reported
Compound solubility: Not reported
Solvent DMSO
Study call: Positive
Title: Genetic Toxicity Evaluation of Fluorobenzene in Salmonella/E.coli Mutagenicity Test or Ames Test. Study 639736
Reference: https://tools.niehs.nih.gov/cebs3/ntpViews/?activeTab=summary&studyNumber=639736
Study type: Bacterial mutagenicity (Ames)
Source: National Toxicology Program
Species: Salmonella typhimurium
Strain/Cell type (Number of tests): TA98 (N=6); TA100 (N=7); TA1535 (N=2)
Metabolic activation (Number of tests): Absent (N=4); Present (N=11)
Metabolic activation system: Aroclor 1254 treated rat liver S-9 fraction (30%), Aroclor 1254 induced hamster liver S-9 fraction (30%)
Dose summary: 0 – 1666 µg/plate; 0 – 750 µg/plate
Toxicity: No cytotoxicity reported
Method: Pre-incubation; Plate test – vapor from liquid
Controls used: Strain (wo S9/w S9): Positive controls: TA98 (4-Nitro-o-phenylenediamine/2-aminoanthracene), TA100 (Sodium azide/2-aminoanthracene), TA1535 (Sodium azide/2-aminoanthracene)
Control values within historical ranges: Yes
OECD test guideline: 471
Current guideline compliance No, insufficient bacterial tester strains used
Study Report: https://tools.niehs.nih.gov/cebs3/ntpViews/?activeTab=detail&studyNumber=639736&reportFormat=XLS
GLP compliance: No
Year conducted 1991
Klimisch score: 3
Rationale for reliability incl. deficiencies: Not tested up to guideline recommended concentrations and insufficient number of strains and not tested according to GLP