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Diss Factsheets
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EC number: - | CAS number: -
- 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:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Developmental Effects and Health Aspects of Soy Protein Isolate, Casein, and Whey in Male and Female Rats
- Author:
- T. M. Badger, M. J. J. Ronis, and R. Hakkak
- Year:
- 2 001
- Bibliographic source:
- International Journal of Toxicology, 20:165–174, 2001
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Adult breeder male and female Sprague-Dawley rats were were randomly assigned to one of three groups and fed one of
three semipurifed diets. Animals were allowed to breed and the offspring were weaned to the same diet as their dams. At
approximately 90 days of age, offspring from different parents within a diet group were mated to produce the F2 generation.
Offspring from both F1 and F2 generations were fed their respective diets throughout their entire lives.
Rats were fed AIN-G93 diets made with either casein protein (CAS), soy protein isolate (SPI), or whey protein hydrolysate (WPH) and bred. The birth weight, weight gains, body length, anogenital distance, and age of puberty (vaginal opening or preputial gland separation) of the F1 generation were measured. The F2 rats were euthanized and their organ weight was measured.
The breeding success (percent of males and females that produced offspring after mating) of the F1 generation, litter size, and percent of female offspring were investigated for three breeding sessions (at ages 90, 180, and 270 days). - GLP compliance:
- not specified
- Remarks:
- published study
Test material
- Reference substance name:
- whey protein hydrolysate
- IUPAC Name:
- whey protein hydrolysate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- All diets were made according to the AIN-93G diet formula (Reeves, Nielsen, and Fahey, 1993), except that corn oil replaced soy oil and the protein source was either CAS,WPH, or SPI. Amino acids were added to each diet to equalize the essential amino acids among diets.
- Frequency of treatment:
- The tested substance was incorporated to the diet and thus fed daili.
- Details on study schedule:
- At approximately 90 days of age, offspring from different parents within a diet group were mated to produce the F2 generation.
Doses / concentrations
- Dose / conc.:
- 200 000 mg/kg diet
- Control animals:
- yes, plain diet
Examinations
- Postmortem examinations (offspring):
- body weights when examined in a separate set of rats at approximately age 55 days
- Statistics:
- Diet group was modeled as a between animals effect and day as a within animal effect. Organ weight and testosterone metabolism data were analyzed by one-way analysis of variance followed by Bonferroni post hoc analysis as described previously (Fisher and van Belle 1993).
Statistical signi cance was set at p < .05, and all p values are not adjusted for multiple comparisons.
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 specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 200 000 mg/kg diet
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Slightly smaller offspring were observed in the WPH group.
Body weights of male rats fed SPI and WPH were similar to each other; and were slightly less than that of CAS-fed rats. Body weights started to diverge from those of CAS-fed pups prior to weaning; and became significantly lower than CAS-fed rats at age 7 weeks (p < .05). After age 7 weeks, body weight gains of SPI- and WPH-fed rats were approximately equal or slightly greater than CAS-fed rats, and by age 18 weeks all groups were statistically the same for body weights. Similar effects were observed in female rats, except that SPI-fed females did not begin to diverge from CAS-fed rats until 7 weeks, and by 9 weeks of age, the body weights of SPI- and WPH-fed rats did not differ significantly, but were less than (p < .05) CAS-fed rats. Thereafter, the body weight gains were approximately equal. - Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- effects observed, treatment-related
- Description (incidence and severity):
- Male offspring fed CAS or SPI did not differ on the mean age of puberty (preputial gland separation), but WPH-fed offspring had puberty 2.0 days later ( p <.05) than CAS controls.
The mean age of puberty in female offspring (age of vaginal opening) was 2.0 days earlier ( p < .05) in the SPI-fed rats than the CAS group and the 1.3 days later ( p < .05) in the WPH group than the CAS group. The effects of diet on puberty were not affected by correction for gestational age. - Organ weight findings including organ / body weight ratios:
- no effects observed
- Other effects:
- no effects observed
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
The breeding success of F1 rats and male/female ratios were not affected by diet.
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 200 000 mg/kg diet
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
Effect levels (F2)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- > 200 000 mg/kg diet
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Rats fed either CAS, SPI, or WPH did not differ in breeding success rate and body size of offspring (birth weight and length).
- Executive summary:
Not classified as toxic for reproduction
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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