Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 213-361-6 | CAS number: 939-48-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This is a summary of in vivo studies compiled by an authoritative body (SCF) which drew conclusions on the impact of human exposures to the test substance.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
- Study type:
- other: risk assessment based on animal studies
- Endpoint addressed:
- other: various endpoints after oral exposure
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: scientifically valid studies according to reproductive toxicity and genetic toxicity protocols
- Principles of method if other than guideline:
- Review of studies and risk assessment
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzoic acid
- EC Number:
- 200-618-2
- EC Name:
- Benzoic acid
- Cas Number:
- 65-85-0
- IUPAC Name:
- benzoic acid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not applicable
- Details on study design:
- Review of published and unpublished animal studies with impact on human risk assessment
Results and discussion
- Results:
- The ADI for benzoic acid and its salts is unchanged at 0-5 mg/kg bw/d, and further in vivo studies (reproductive/developmental toxicity and genotoxicity) are no longer required.
Any other information on results incl. tables
Benzoic acid and its salts are in widespread use as food preservatives in the EU. The Scientific Committee for Food (SCF) was first asked to evaluate the safety of benzoic acid and its salts in 1994. In this opinion (SCF, 1994), the Committee raised questions about developmental toxicity and genotoxicity and asked for further studies in these two areas. In view of these data requests, the Committee set only a temporary ADI, of 0 - 5 mg/kg bw based on an overall NOAEL of 500 mg/kg bw/day from long-term and multigeneration studies. The benzoates had previously been evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which established an ADI of 0 - 5 mg/kg bw as a sum of benzoic acid and its salts, expressed as benzoic acid (JECFA, 1974). At a later meeting, JECFA recommended a full review of benzoic acid and its salts, together with the flavouring substances benzyl acetate, benzyl alcohol and benzaldehyde (JECFA 1993), in order to determine whether additional studies were needed. In particular the absence of reproductive and developmental toxicity studies was noted. These substances were grouped because of their common metabolic pathway. After receipt of new information, they were re-evaluated in 1996 and the Group ADI of 0 - 5 mg/kg bw was maintained (JECFA, 1997). JECFA was satisfied that the data were sufficient to demonstrate lack of carcinogenicity and lack of toxicity to development and reproduction. The genotoxicity database was also reviewed at that time.
Conclusions: The updated database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity. There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on fetal weight. The fact that this overall NOAEL takes into account gavage as well as dietary studies gives further reassurance. It is therefore concluded that a further teratogenicity study on benzoic acid should no longer be required. Similarly for genotoxicity, while some of the in vitro tests have been positive or equivocal, all the results from in vivo studies have been negative. It is therefore concluded that an in vivo study for clastogenic activity on benzoic acid should no longer be required. On the basis of these data and the other types of study previously evaluated by the Committee, the Committee can establish a full Group ADI of 0 - 5 mg/kg bw for benzoic acid and its salts including benzyl alcohol and related benzyl derivatives used as flavourings.
Applicant's summary and conclusion
- Conclusions:
- The human ADI for benzoic acid and its salts is unchanged at 0-5 mg/kg bw/d, and newly-commissioned in vivo studies (reproductive/developmental toxicity and genotoxicity) are no longer required to be undertaken. This study is informative for evaluation of the toxicity of members of the Alkyl Benzoates category.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.