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EC number: 309-203-1 | CAS number: 100085-61-8 Substance obtained by acidic, alkaline, or enzymatic hydrolysis of mixed animals composed primarily of amino acids, peptides, and proteins. It may contain impurities consisting chiefly of carbohydrates and lipids along with smaller quantities of miscellaneous organic substances of biological origin.
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline but not TG indicated.
- Principles of method if other than guideline:
- The study was conducted in compliance with the good laboratory practices (US FDA, 1987), and in accordance with OECD guidelines (OECD, 1987) at Product Safety Laboratories (Dayton, NJ, USA). One group of males and one group of females were assigned to one of the four treatments: control (distilled water), low dose (30 mg test product/kg/day), intermediate dose (300 mg test product/kg/day), or high dose (1000 mg
test product/kg/day). The human exposure to the test substance, based on the label recommendation found in the dietary ‘‘supplement facts’’ panel, was up to 30 mg/kg/day. Thus, the dose levels selected for this study corresponded to 0, 1, 10, and 33 times the expected human exposure level. The highest level (33 times) is considered as a regulatory limit dose for rats and was expected to exhibit some evidence of toxicity. A NOAEL was expected at 300 mg/kg/day.
The individual doses of the test product were determined based on each animal body weight and prepared within 2 h of administration as a 0.6% (low), 6.0% (intermediate), and 20% (high) w/v solution in distilled water. All doses were volumetrically equal (100 mL) and administered orally using a stainless steel ball-tipped gavage needle attached to a syringe.
The dose administration was performed at the same time each day (± 2 h) for 92 (males) or 93 (females) consecutive days. The control animals received distilled water at the same volume (100 mL) as the test groups. - GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- dayly
- Remarks:
- Doses / Concentrations:
20% (high) w/v
Basis:
nominal in water - Remarks:
- Doses / Concentrations:
6.0% w/v (intermediate)
Basis:
nominal in water - Remarks:
- Doses / Concentrations:
0.6% w/v (low)
Basis:
nominal in water - No. of animals per sex per dose:
- 40 males and 40 females total.
10 males and 10 females per dose - Control animals:
- yes
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- mortality
- Critical effects observed:
- not specified
- Conclusions:
- A GLP, OCDE Guideline study indicates a NOAEL higher that 1.000 mg/Kw bw
Reference
There was no mortality, adverse effects or clinical signs of toxicity during the study associated with the treatment.
One male from the intermediate dose group was euthanized on day 38 after the animal was found moribund. Postmortem analysis revealed a red discharge from the animal’s eyes and nose, nasal swelling, crooked or broken teeth, and minimal stomach content. These symptoms indicated an injury sustained in the cage and were not related to the treatment.
Male and female animals treated with the test substance had an average body weight and average body weight gain comparable to those from the control group.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Additional information
Justification for classification or non-classification
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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