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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 701-270-9 | 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Remarks:
- No deviations ocurred that adversely impacted the integrity of the study.
- GLP compliance:
- no
- Remarks:
- This study was conducted prior to the intention to register the substance for REACH. The study was well-documented and is scientifically valid.
Test material
- Reference substance name:
- Reaction product of Fatty acids, C18-unstaturated, dimer with 4,7,10-trioxa-1,13-tridecane-diamine
- EC Number:
- 701-270-9
- Cas Number:
- 68911-25-1
- Molecular formula:
- N.A. UVCB substance
- IUPAC Name:
- Reaction product of Fatty acids, C18-unstaturated, dimer with 4,7,10-trioxa-1,13-tridecane-diamine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot 20125
- Expiration date of the lot/batch: No data
- Purity test date: 21 January, 2015
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, dosed neat
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Human Keratinocytes cultivated in vitro to resemble human epidermis.
- Cell source:
- other: Proprietary EpiDerm reconstructed human epidermis tissues were purchased from MatTek Corporation
- Details on animal used as source of test system:
- SOURCE ANIMAL
Proprietary EpiDerm reconstructed human epidermis tissues were purchased from MatTek Corporation - Justification for test system used:
- EpiDerm is an appropriate test system per OECD 439.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Irritation Test (EPI-200-SIT)
- Tissue batch number(s): No data
- Production date: No data
- Shipping date: No data
- Delivery date: 03 February, 2015
- Date of initiation of testing: 02 February, 2015
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 C
- Temperature of post-treatment incubation (if applicable): 37 C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The tissue inserts were filled and emptied 20 times with fresh DPBS from a wash bottle.
- Observable damage in the tissue due to washing: No
- Modifications to validated SOP: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: No data
- Incubation time: 3 hours
- Spectrophotometer: No data
- Wavelength: 570 nm
- Filter: No data
- Filter bandwidth: No data
- Linear OD range of spectrophotometer: No data
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues
- Procedure used to prepare the killed tissues (if applicable): Freezing
- N. of replicates : 2
- Method of calculation used: % Viability of negative test system control
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be an irritant if the mean tissue viability (as a percentage of the negative control) was less than or equal to 50%. - Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 uL
- Concentration (if solution): Dosed undilluted.
VEHICLE : None
NEGATIVE CONTROL : DPBS
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution): No data
POSITIVE CONTROL : SDS
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 19
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
Any other information on results incl. tables
Mean % tissue viablity for the test article was 11%.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on the results of the study (11% mean tissue viability following 60 minute exposure), MTDID 18990 is a skin irritant.
- Executive summary:
The dermal irritation potential of MTDID 18990 was evaluated in the EpiDerm reconstructed human epidermal tissue model. The study was conducted according to OECD 439. EpiDerm tissues (n=3) were exposed to 30 uL of test article (neat), DPBS (negative control) or SDS (postive control) for 60 minutes at 37C. Following exposure, the tissues were washed 20 times by filling the plate wells with a gentle stream of DPBS and emptying. The plate wells were then filled with fresh media and returned to an incubator at 37C for 24 hours. At 24 hours, the media was replaced with fresh media and incubated for another 18 hours. Following incubation the tissues were patted dry with a tissue and transferred to plates containing 300 uL of MTT solution per well. The tissues were incuabted with MTT for 3 hours. Following incubation they were washed and the wells were filled with MTT extraction soltuion and extracted for 2 hours at room temperature. The OD at 570 nm was measured for each solution and normalized to the mean of the negative control group to calculate % tissue viability. MTDID 18990 -exposed tissues had % viability values of 8, 5, and 19% for a mean tissue viability of 11%. Based on the results of the study (11% mean tissue viability following 60 minute exposure), MTDID 18990 is a skin irritant.
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