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EC number: 249-984-5 | CAS number: 29976-53-2
- 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:
- 2006-06-28 to 2006-07-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well-documented, GLP-compliant study, performed according to OECD and / or EC guidelines
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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:
- Ethyl 4-oxopiperidine-1-carboxylate
- EC Number:
- 249-984-5
- EC Name:
- Ethyl 4-oxopiperidine-1-carboxylate
- Cas Number:
- 29976-53-2
- Molecular formula:
- C8H13NO3
- IUPAC Name:
- ethyl 4-oxopiperidine-1-carboxylate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-126971-AAA (T000509)
- Physical state: liquid
- Appearance: clear colourless to light yellow liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:young New Zealand White rabbit (SPF), from Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst, The Netherlands
- Age at study initiation: 11weeks (male), 10-11 weeks (females)
- Weight at study initiation: animal 46: 2323, animal 47: 2041,animal 48: 2114
- Housing: Housed in compliance with AALAC regulations. Standard laboratory conditions, individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 were provided for gnawing.
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum provided by Provimi Kliba. Results of analysis for contaminants are archived.
- Water (e.g. ad libitum): community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are archived.
- Acclimation period: 2006-06-28 to 2006-07-02; under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C):17-23°C
- Humidity (%):30-70%
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12/12. Music was played during the daytime light period
IN-LIFE DATES: From: 2006-07-03 To: 2006-07-07
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable, test item was appplied undiluted - Duration of treatment / exposure:
- single dose for 4 hour exposure
- Observation period:
- -observations: viability/mortality, clinical signs: daily from acclimatization of the animals to the termination of test
-body weights: at start of acclimatization, on the day of application and at termination of observation
-skin reaction: 1, 24, 48 and 72 hours after exposure (remvoal of the dressing, gauze patch and test item. - Number of animals:
- 3 animals per test (1 male and 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: left flank; on the day of treatment, 0.5ml of T509 was placed on a surgical gauze patch (ca. 2.5 x 2.5 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing.
- % coverage:no data on % (2.5 x 2.5 cm)
- Type of wrap if used: The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was flushed with lukewarm tap water to clean the application site so that any reactions were clearly visible at that time.
- Time after start of exposure: 4hours
SCORING SYSTEM: the skin reaction was assessed according to the numerical scoring system listed in the Commission directive 2004/73/EC, April 29, 2004. The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after exposure (removal of the dressing, gauze patch and test item). If evident, corrosive or staining properties of the test item were described and recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal:
- Remarks:
- 46
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: clipped skin
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal:
- Remarks:
- 47
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: clipped skin
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal:
- Remarks:
- 48
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: clipped skin
- Irritation parameter:
- edema score
- Remarks:
- mean
- Basis:
- animal:
- Remarks:
- 46
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: clipped skin
- Irritation parameter:
- edema score
- Remarks:
- mean
- Basis:
- animal:
- Remarks:
- 47
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: clipped skin
- Irritation parameter:
- edema score
- Remarks:
- mean
- Basis:
- animal:
- Remarks:
- 48
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: clipped skin
- Irritant / corrosive response data:
- The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
- Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), T509 is considered to be not irritating to rabbit skin.
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