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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 205-702-2 | CAS number: 147-85-3
- 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
Endpoint summary
Administrative data
Description of key information
An acute oral LD50 value of > 5110mg/kg bw from a reliable study was derived. No mortality occured during the observation period of 14 days. No signs of toxicity were observed either at the male nor the female animals.
The acute dermal study and the acute inhalation study were waived based on the very low systemic toxicity as well as on the physico-chemical and toxikokinetic properties.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983-03-10 to 1983-04-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Intercomparison Study on the Determination of Single Administration Toxicity in Rats, Commission of the European Communities, Health and Safety
Directorate, J. Assoc. Off. Anal. Chem. 62, 864-873, 1979 - GLP compliance:
- no
- Remarks:
- Study performed prior to implementation of GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: males 48 - 51 days, females 55 - 62 days
- Weight at study initiation: males 129 - 135 g, females 129 - 138 g
- Fasting period before study: 16 hours
- Housing: Makrolon cages type II
- Diet (e.g. ad libitum): standardised test animal diet ALTROMIN
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days acclimatisation period before study begin
ENVIRONMENTAL CONDITIONS
According to method
IN-LIFE DATES: From: To: no data available - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 238 mg/ml
- Amount of vehicle (if gavage): 21.5 ml/kg
- Justification for choice of vehicle: solubilty, inherent vehicle
- Lot/batch no. (if required): not applicable
- Purity: ca. 100 %
MAXIMUM DOSE VOLUME APPLIED: 21.5 ml/kg - Doses:
- 5110 mg/kg
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data available
- Necropsy of survivors performed: no data vailable - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the observation period of 14 days.
- Clinical signs:
- other: No signs of toxicity were observed either at the male nor the female animals.
- Gross pathology:
- No data available
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The LD50 value of L-proline via the oral route represented by male and female rats was > 5110 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 110 mg/kg bw
- Quality of whole database:
- The study was performed prior to the implementtaion of GLP but isomparable to guideline study with acceptable restrictions.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
L-proline did not show any mortality in an oral acute toxicity study. The LD50 value of L-proline via the oral route represented by male and female rats was > 5110 mg/kg body weight.
No toxic effects were observed in a 13 week sub-chronic oral toxicity study in which L-proline was adminstered in an oral daily dose up to 5 %. These results show that the toxicity of L-proline via the oral route is extremely low.
Inhalation is not a relevant route based upon the vapour pressure and particle size (granulometry) of L-proline.
There is sufficient weight of evidence for the absence of acute toxicity via the inhalation route.
No data on acute dermal toxicity for L-proline is available. Due to its very low systemic toxicity and the fact that L-proline (with high water solubility and a log P value well below 0) may be too hydrophilic to cross the lipid rich environment of the stratum corneum it is highly improbable that an acute dermal toxicity study would result in any toxicity.
Justification for selection of acute toxicity – oral endpoint
Key study
Justification for classification or non-classification
Based on the data available no classification for acute toxicity (oral toxicity, dermal toxicity, inhalation toxicity) is required.
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.