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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 206-229-4 | CAS number: 312-84-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 January 2005 to 22 February 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- D-serine
- EC Number:
- 206-229-4
- EC Name:
- D-serine
- Cas Number:
- 312-84-5
- Molecular formula:
- C3H7NO3
- IUPAC Name:
- D-serine
- Test material form:
- solid
- Details on test material:
- - Appearance: white solid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light
- Stability under storage conditions: stable under storage conditions
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 - 13 weeks old
- Weight at study initiation: 2.12 - 2.29 kg on the day of treatment
- Housing: animals were housed individually in stainless steel cages furnished with wood blocks and haystacks
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 30 - 70%
- Air changes (per hr): ca 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: test material was moistened with 0.1 mL distilled water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours following application of the test material
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: the left flank was clipped free of fur exposing an are of ca. 100 cm²
- Type of wrap if used: test material was covered with a gauze patch (ca 4 cm x 4 cm) which was itself covered with a semi-occlusive dressing. The dressing was wrapped around the animal and fastened with tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 4 hours exposure the dressings were removed and the skin flushed with lukewarm tap water
OBSERVATION TIME POINTS
Observations for viability/mortality and clinical signs were made daily. Body weights were recorded on the day of application and at the end of the observation period.
Skin irritation was assessed at 1, 24, 48 and 72 hours after removal of the dresings and test material.
SCORING SYSTEM:
- Method of calculation: Draize score system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 24, 25, 26
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 24, 25, 26
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test material did not illicit any skin reactions at the application site of any animal at any of the observation times (all scores were 0).
- Other effects:
- - Viability, mortality and clinical signs: No clinical signs of systemic toxicity were observed and no mortality occurred.
- Body weights: the body weights of all animals were considered to be in the normal range of variability. All animals gained weight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: the substance does not meet the criteria for classification as a skin irritant
- Conclusions:
- Under the conditions of the study, the substance does not meet the criteria for classification as a skin irritant.
- Executive summary:
The skin irritation potential of the test material was investigated in a study which was conducted in accordance with the standardised guidelines OECD 404 and EU Method B.4 and under GLP conditions.
During the study the test material was applied by topical semiocclusive application of 0.5 g to the intact left flank of each of three New Zealand White rabbits. The duration of treatment was 4 hours. Skin reaction were assessed 1, 24, 48 and 72 hours following removal of the test material.
Under the conditions of the study, no clinical signs of systemic toxicity were observed and no mortality occurred. Body weights of all animals were considered to be in the normal range of variability. All animals gained weight during the study.
The test material did not illicit any skin reactions at the application site of any animal at any of the observation times (all scores were 0). The test material is therefore not considered to be a skin irritant.
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.