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EC number: 239-471-4 | CAS number: 15454-74-7
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Patch test on human volunteers
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 3 distincts periods on the protocol :
- Induction period : 9 consecutive applications, to the same area (0.02ml per volunteer, diluted to 5%, by occlusive epicutaneous route for about 48 hours or for the first two week-ends 72 hours, to the arm skin. Preparation being under a liquid form, was put onto a disc of filter paper inserted beforehand into cupule.
- Rest period : or incubation period during which the cells transformations possibly go on, leading to the modification or reactivity;
15 days without any application
- Challenge phase : singla application of about 0.02 ml per volunteer of the test article diluted to 5% by epicutaneous occlusive route for about 48 hours, to the back skin.
Cutaneous reaction, control of the sensitization was evaluated by the macroscopic examination of the reactions possibly noted about 24 and 48 hours after removal of the patches corresponding to the "challenge" application.
These examination were eprformed for the 1th, 8th (induction) and 10th (challenge) applications by comparison to the reactions possibly obtained with a patch alone (without test article), applied in parallel under the same conditions (negative control)
As regards evaluation of the sensitising potential, a reaction whose intensity is equal to 3 (erythema with infiltration, papulae, vesicles) was considered as "positive". If an individual irritation reaction had been noted during the first application, of after those corresponding to induction, or if an erythema was observed to the control area (right side), the test article was considered as "positive" if the challenge application had provoked a reaction whose intensity was clearly higher, and/ or if it had tented to increase as the readings were performed. - GLP compliance:
- yes
- Remarks:
- Good Clinical practices
- Type of study:
- patch test
- Justification for non-LLNA method:
- As the study provided show no skin sensitising potential, and since this result is supported by public data and the assessment report of copper, no further testing are required, especially in vivo assays such as LLNA assay.
Test material
- Reference substance name:
- Calcium bis(5-oxo-L-prolinate)
- EC Number:
- 250-602-4
- EC Name:
- Calcium bis(5-oxo-L-prolinate)
- Cas Number:
- 31377-05-6
- Molecular formula:
- C5H7NO3.1/2Ca
- IUPAC Name:
- calcium;(2S)-5-oxopyrrolidine-2-carboxylate
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 65 volunteers of both sexes, healthy adults, were recruited and selected after a general medical examination taking into account the inclusion and non-inclusion criteria (which are presented hereafter), as well as the prohibition and restriction concepts defined in the study protcol.
All of the panellists were then finally included by the Investigator on the basis of a clinical examination specific to the study, performed just before its start, after signature of, among other things, the compensation modes form and of the informed consent statement : 2 of them abandoned during the induction phase (not linked to the test article applications).
Analysis of the results was thus made from a selection of 51 panellists composed of 46 (or 44) women and 7 men, from 21 to years old.
Inclusion criteria :
- Caucasian
- Age : from 18 to 70 years old
- Sex : Both
- Weight : included within the limits of the scale proposed by the Metropolitan Insurance Company
- Health condition : it correspond to the selection criteria defined in the procedures of I.E.C. Bulgarie, in order to eliminate, as much as possible, the volunteers incurring risks or presenting with redhibitory affections for the clinical studies performed by I.E.C. Bulgarie. These criteria were evaluated on the basis of questionnaires and clinical examinations listed in the protocol
- Volunteers with fixed abode
- Understanding of bulgarian language
Non-inclusion criteria :
- Volunteers not respecting rules related to the biomedical research
- Having participated in a sensitisation trial for 2 months and/ or in photo-irritation or photo-sensitisation study for 3 months
- Deprived from liberty by a judiciary or administrative decision, sick volunteers in situation of emergency
- Under age protected by law, as well as those admitted in sanitary or social facilities, ever since the research can be performed in another manner
- Having refused to give their agreement
- Having undergone organ excision, organ transplant, skull concussion with extended loss of consciousness for less than 5 years or with present after-effects
- Volunteers pregnant or breastfeeding mohthers, or not using medically acceptable contraceptive methods
- Having cardiovascular, pulmonar, digestive, neurologic, psychatric, genital, urinary, haematological, endocrine disorders, immunological deficit, an allergic background, a skin disease, a febrile illness
- Having intolerance to cosmetics, body hygiene or domestic products, to clothes, to products used at work such as colophane, rubber, nickel, aluminium
- Having had or being in the course of a long-term treatment
- Volunteers who recently sufferef from insolation, or having followed heliotherapy during the month preceding the start of the study
- Volunteers smoking more than 10 cigarettes a day and not accepting restriction of their tobacco consumption during the two days prior to the start of the study and throughout the whole study
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- 51
- Details on study design:
- Application of the test article were performed under occlusive patches, composed of an 8 mm-diameter aluminium cupule covering a contact surface of 50 mm2.
Preparation being under a liquide form, was put just before application, onto a disc of filter paper (7mm in diamter) inserted beforehand into the cupule.
About of 0.02 ml per volunteer of the test article diluted to 5% into distilled water (justification of the dose level : capacity of the cupule)
There is 3 phases :
- Induction period : application during 48 hours or 72 hours on the left area. A negative control is carried out on the right arm.
- Rest period : Volunteers were not submitted to any application from day 21 to day 35 for a 15 day period.
- "Challenge" phase : product is applied on the back during 48 hours. A negative control (patch alone, without test article) is also performed. - Challenge controls:
- A negative control (patch alone, without test article) is also performed.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.02 ml diluted to 5%
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.02ml diluted to 5%
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Reading:
- other: No positive control performed
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Remarks on result:
- other: Number of volunteer in the negative group are not mentioned
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Remarks on result:
- other: Number of volunteer in the negative group are not mentioned
Applicant's summary and conclusion
- Interpretation of results:
- other: Integrated approach
- Conclusions:
- Under the experimental conditions, single and repeated epicutaneous applications of this test article, diluted at 5%, under occlusive patch, in the healthy volunteer did not provoke any cutaneous sensitisation.
Human in vivo assays could not be used alone to set a classification for skin sensitisation but can be used on an integrated approach.
Therefore, based on an integrated approach, and under the tests conditions, the patch assay can support a non classificaqtion for skin sensitisation.
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