Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 200-091-9 | CAS number: 51-35-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study dates from 1971, although not meeting the current acute toxicity guidelines and GLP requirements and lacking described details, the study reveals usefull data considering the LD50 in rats.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test: Oral gavage of very high dose
- Parameters analysed / observed: Mortality, behaviour, signs of toxicity; macroscopic examination - GLP compliance:
- no
- Test type:
- other: Divided doses at 2 h intervals.
- Limit test:
- no
Test material
- Reference substance name:
- L-4-hydroxyproline
- EC Number:
- 200-091-9
- EC Name:
- L-4-hydroxyproline
- Cas Number:
- 51-35-4
- Molecular formula:
- C5H9NO3
- IUPAC Name:
- L-4-hydroxyproline
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Carworth Europe, Huntingdon
- Weight at study initiation: 62 - 123 g
- Fasting period before study: 20 hours before dosing and 4 hours after dosing
- Housing: caged in groups according to sex and age
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: water or methyl cellulose
- Details on oral exposure:
- Vehicle:
- Concentration in vehicle: 30% solution in water or suspension - Doses:
- Test 1: 0, 4, 8, 16 g/kg bw
Test 2: 0, 8.0, 10.0, 12.5, 16.0 g/kg bw - No. of animals per sex per dose:
- Test 1: 2 males and 2 females
Test 2: 5 males and 5 females - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a week
- Necropsy of survivors performed: yes
- Other examinations performed: body weight/behaviour - Statistics:
- Method of Litchfield J.T., Wilcoxon F (1949), J. Pharmac. exp. Ther. 96, 99
Results and discussion
- Preliminary study:
- The results of the preliminary range finding indicated that the median lethal dose LD50 was in the range of 16000 mg/kg bw.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality occured 22 hours after dosing
- Clinical signs:
- other: Lethargic behaviour wa sthe only observed sign of reaction to the treatment.
- Gross pathology:
- Autopsy did not reveal any specific cause of death.
- Other findings:
- Recovery of survivors, as jugged by external appearance and behaviour, was apparently complete within 3 days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 > 16000 mg/kg
- Executive summary:
LD50 > 16000 mg/kg
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.
