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Diss Factsheets
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EC number: 224-221-9 | CAS number: 4253-34-3
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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:
- publication
- Title:
- Unnamed
- Year:
- 1 956
Materials and methods
- Principles of method if other than guideline:
- Rats were fed with diets containing 1.2% citric acid (about 600 mg/kg bw/day). Exposure began 29 weeks prior to mating and continued for a few months after mating. The reproduction of the rats was investigated when they were 32 weeks old and had received the diets for 29 weeks. Eleven weeks later the same animals were mated again.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Citric acid
- EC Number:
- 201-069-1
- EC Name:
- Citric acid
- Cas Number:
- 77-92-9
- Molecular formula:
- C6H8O7
- IUPAC Name:
- citric acid
- Details on test material:
- - Name of test material (as cited in study report): citric acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Diet (e.g. ad libitum): Basal diet: Casein 6.0 %, Dried full milk 10.0 %, Whole wheat flour 34.5 %, Potato flour 33.0 %, Peanut oil 6.5 %, Cod liver oil 0.5 %, Linseed oil 0.5 %, Brewer's yeast 5.0 %, Ca2(PO4)2 1.9 %, Na2HPO4 . 2H20 0.8 %, KCl 0.9 %, MgCO3 0.2 %, Na-citrate 0.1 %, various salts 0.1 %.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on exposure:
- Treated rats were fed diets containing 1.2% citric acid.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Several months. Exposure began 29 weeks prior to mating and continued for a few months after mating.
- Frequency of treatment:
- Daily
Doses / concentrations
- Dose / conc.:
- 1.2 other: % in diet
- Remarks:
- 1.2 % (ca. 600 mg/kg bw/day)
Basis: nominal in diet
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Positive control:
- No data
Examinations
- Parental animals: Observations and examinations:
- Fertility of female rats.
The reproduction of the rats was investigated when they were 32 weeks old and had received the diets for 29 weeks. Eleven weeks later the same animals were mated again. - Statistics:
- The statistical methods used in the evaluation of the results have been described in detail. The bilateral tail probability (p), i.e. the probability that the difference found be accidental, was calculated in each instance. The difference was considered significant, whenever p was smaller than 0.05.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No reproductive effects were detected.
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 600 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- reproductive performance
- Remarks on result:
- other: No adverse effect observed at the highest dose tested
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- > 600 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- reproductive performance
- Remarks on result:
- other: No adverse effect observed at the highest dose tested
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Other effects:
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Any other information on results incl. tables
No reproductive effects were detected. The NOAEL for reproductive effects was 600 mg/kg bw/day. The LOAEL was higher than 600 mg/kg bw/day for the same effects.
Applicant's summary and conclusion
- Conclusions:
- No reproductive effects were detected. The NOAEL for reproductive effects was 600 mg/kg bw/day. The LOAEL was higher than 600 mg/kg bw/day for the same effects.
- Executive summary:
A fertility test was carried out with Citric Acid on rats. Animals were fed diets containing 1.2% citric acid (about 600 mg/kg bw/day). Exposure began 29 weeks prior to mating and continued for a few months after mating. The reproduction of the rats was investigated when they were 32 weeks old and had received the diets for 29 weeks. Eleven weeks later the same animals were mated again.
No reproductive effects were detected. The NOAEL for reproductive effects was 600 mg/kg bw/day. The LOAEL was higher than 600 mg/kg bw/day for the same effects.
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.
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