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Diss Factsheets
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EC number: - | CAS number: -
- 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)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- From 28 February 2000 to 27 October 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is a screening test but followed international guidance requirements with acceptable restrictions.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- : screening test/ 5 animals in the main test rather than 10, only one concentration tested, no certificate of analysis included
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The GPMT study was already available before the substance had to be registered under Reach regulation.
Test material
- Test material form:
- other: Liquid at ambient temperature
- Details on test material:
- - Name of test material (as cited in study report): Dermalcare MAP L-213/K
- Physical state: clear liquid
- Stability under test conditions: assumed to be stable by the sponsor
- Storage condition of test material: ambient temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Nossan S.r.l., Italy
- Age at study initiation: no data
- Weight at study initiation: approximately 626 g
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: To: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction (intradermal) : 0.1%
Induction (epicutaneous) : 60%
Challenge: 30%
Challengeopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction (intradermal) : 0.1%
Induction (epicutaneous) : 60%
Challenge: 30%
- No. of animals per dose:
- Preliminary test: 3 treated animal
Main study: 3 animals for the control group, 5 animals for the treated group - Details on study design:
- RANGE FINDING TESTS: one animal was treated by an intradermal injection of different concentrations of test item (0.5-50%) and erythema was scored at the injection site 6 days after the intradermal injection. The test item was corrosive (necrosis) from the concentration of 0.5%. However the effects were lower at the lowest concentrations of 0.5 and 1%. Two additionnal animals were examined for skin irritation 24 and 48 hours after a topical application of the test item at different concentrations (5-60%). The test substance applied topically was not irritating whatever the tested concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: -
- Test groups: Test substance in Freund's Complete Adjuvant (FCA) emulsion and in water. Before the topical application, sodium Lauryl sulphate was applied on the skin to promote an irritant reaction.
- Control group: Test substance in water
- Site: no data
- Frequency of applications: intradermal injection, then one week later topical application
- Duration: 0-7 days
- Concentrations: intradermal 0.1%, topical 60%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: -
- Test groups: Test substance in water
- Control group: Test substance in water
- Site: no data
- Concentrations: 30%
- Evaluation (hr after challenge): 24 and 48 hrs - Challenge controls:
- There is no reference to a positive historical control substance.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- no data
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- no data
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- one animal dead
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- one animal dead
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
One animal in the treated group was found dead during the observation period (no more details are given in the study report).
Animals gained weight during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Dermalcare MAP L-213/K is not a skin sensitiser in the guinea pig maximisation test.
- Executive summary:
In a guinea pig maximisation test (screening study) performed similarly to the OECD No. 406 guideline, Dermalcare MAP L-213/K diluted in sterile water was tested for its skin sensitising potential in Dunkin-Hartley guinea pigs. A preliminary test on one animal allowed determining the appropriate concentrations of the test item for the induction and the challenge phases of the main study. Indeed, 6 days after an intradermal injection strong irritant skin effects were observed with signs of necrosis. Those effects were observed from concentrations of 0.5%. However at 0.5 and 1% the effects were decreased compared to the higher concentrations. The concentration of intradermal induction of 0.1% was therefore chosen for the main test. 24 and 48 hours after a topical application, the test item applied on the skin up to 60% induced no sign of irritation. Therefore the concentrations of 60% for the topical induction phase and of 30% for the challenge phase were chosen for the main test.
For the main test, 3 animals were treated only with the vehicle (water) (control group) and 5 animals were treated with the test substance.
For the induction phase, animals received an intradermal injection of the test substance at 0.1% in sterile water or in Freund’s Complete adjuvant (FCA) emulsion. One week later, a second induction was performed by a topical application of the test item at 10% in water. Before this topical induction, the skin was treated with Sodium Lauryl sulfphate to promote an irritant reaction.
Two weeks after the topical induction phase, challenge was performed by applying the test substance at 1% in water on the skin of guinea pigs. The observation of skin irritation 24 and 48 h after the challenge treatment informs on the skin sensitising potential of the test item.
No sign of skin sensitisation was observed 24 and 48 hrs after the challenge in any animals (control and treated groups). The body weight was recorded and no effect was observed.
Therefore, under the test conditions, Dermalcare MAP L-213/K is not considered as a skin sensitiser according to the criteria of Regulation (EC) 1272/2008 (CLP) and Directive 67/548/EEC.
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.
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