Registration Dossier
Registration Dossier
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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.
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EC number: 232-435-9 | CAS number: 8028-89-5 The substance obtained by controlled heat treatment of food-grade carbohydrates. Food-grade acids, alkalies, and salts may be used to assist carmelization. Food-grade antifoaming agents may be used in an amount not greater than that required to produce the intended effect. Consists essentially of colloidal aggregates that are dispersible in water but only partly dispersible in alcohol-water solutions. Depending upon the particular carmelizing agent used, may have a positive or negative colloidal charge in solution.
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: not specified
- Principles of method if other than guideline:
- Six ammonia caramels, three double strength and three single strength, each differing in contents of 4-methyl imidazole, were examined in a reproduction study in rats, at dietary levels of 2-15%. Only one litter was reared. Observations were made on the fertility of females, the number of young born per litter, grossly visible abnormalities, mortality, body weights and resorption quotient.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Caramel (color)
- EC Number:
- 232-435-9
- EC Name:
- Caramel (color)
- Cas Number:
- 8028-89-5
- Molecular formula:
- C6H12OH
- IUPAC Name:
- Caramel
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: feed
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 15 other: % caramel/diet
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 11 250 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- not specified
Results: P1 (second parental generation)
Effect levels (P1)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 15 other: % caramel/diet
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 11 250 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
Target system / organ toxicity (P1)
- Key result
- Critical effects observed:
- not specified
Results: F1 generation
Effect levels (F1)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 15 other: % caramel/diet
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 11 250 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
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.
