Scope & Applicability
Product Classes
1Category of solvents including Acetic Acid and Acetone
Stakeholders
10Animal model used for carcinogenicity and toxicity testing; Animal model used in 90-day inhalation study; Subjects in inhalation toxicity study; F344 rats given 66, 200, 600, 1800 or 5000 ppm by inhalation
given by inhalation to SC rats
Animal model used in toxicity studies; New Zealand White rabbits used in tacrolimus and thalidomide studies.
administered by gavage to 5D rats daily
Animal model used in carcinogenicity study for 2-Propanol.
Specific rat strain used for 1-Pentanol animal toxicity study.
Animal model used in nervous system damage study
Animal model used for teratology data
Animal model used in toxicity study
Animal model used in toxicity studies.; Animal model used in inhalation study; Carcinogenicity study subjects; Animal model used in nitromethane carcinogenicity study; Animal model used in subchronic inhalation toxicity study; Animal model used in Toluene carcinogenicity studies.; Animal model used in gavage study; Animal model used in carcinogenicity studies.
Regulatory Context
Attributes
10No observed effect level for reproductive toxicity in rabbits
NOEL 600 ppm for CD-1 mice
NOEL 1800 ppm for SC rats; NOEL 1800 ppm. Ref. Chhabra RS et al.
NOEL is 20 mg/kg for Rhesus monkeys
NOEL 240 mg/kg for NZW rabbits
NOEL 400mg/kg for 5D rats
No Observed Effect Level for 2-Propanol in drinking water.
Lethal dose for 50% of rats for 1-Propanol.
Calculated PDE for 2-methyl-1-propanol
Acute oral toxicity in rats
Identified Hazards
Hazards
1Observed in hamsters at high doses of DMSO (exencephaly, cleft lip).
Related CFR Sections (5)
- 21CFR184.1005§ 184.1005 Acetic acid.
(a) Acetic acid (C 2 H 4 O 2 , CAS Reg. No. 64-19-7) is known as ethanoic acid. It occurs naturally in plant and animal tissues. It is produced by fermentation of carbohydrates or by organic synthesis. The principal synthetic methods currently employed are oxidation of acetaldehyde derived from ethyRead full regulation →
- 21CFR73.1§ 73.1 Diluents in color additive mixtures for food use exempt from certification.
The following substances may be safely used as diluents in color additive mixtures for food use exempt from certification, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified Read full regulation →
- 21CFR182.60§ 182.60 Synthetic flavoring substances and adjuvants.
Synthetic flavoring substances and adjuvants that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:Read full regulation →
- 21CFR184.1293§ 184.1293 Ethyl alcohol.
(a) Ethyl alcohol (ethanol) is the chemical C 2 H 5 OH.Read full regulation →
- 21CFR172.515§ 172.515 Synthetic flavoring substances and adjuvants.
Synthetic flavoring substances and adjuvants may be safely used in food in accordance with the following conditions.Read full regulation →