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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- Version / remarks:
- 2017
- Deviations:
- no
- Remarks:
- No deviations ocurred that negatively impacted the integrity of the study.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
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 number of test material:
3M Company, Lot 4293484
- Expiration date of the lot/batch:
31 January 2021
- Purity test date:
10 November, 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At room temperature protected from light
- Stability under storage conditions:
No data
- Stability under test conditions:
No data
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium:
The test article was dosed neat.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
: The test article was dosed neat.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 9-12 weeks old
- Weight at study initiation: 184-212
- Housing: On arrival, animals were group housed (up to 5 animals of the same sex together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) and following assignment to the study, an imals were individually housed in polycarbonate cages (Makrolon MIII type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles. The room in which the animals were kept was documented in the study records. Animals were separated during designated procedures/activities. Each cage was clearly labeled.
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study, except during designated procedures.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24 (mean 21)
- Humidity (%): 40-64
- Air changes (per hr): 10 or greater
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 06 May, 2019 To: 17 June, 2019
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5x7 cm on the back of each rat
- % coverage: Approximately 10%
- Type of wrap if used: The test item was held in contact with the skin with a dressing, consisting of
a surgical gauze patch (Surgy 1D), successively covered with Coban elastic bandage. A piece of
Micropore tape was additionally used for fixation of the bandages.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, 24 hours after the start of exposure with water.
- Time after start of exposure: 24 hours.
OBSERVATION TIME POINTS : The skin reactions were assessed at approximately 24, 48 and 72
hours after the removal of the dressing and test item.
SCORING SYSTEM:
- Method of calculation: Draize - Duration of exposure:
- 24 hours
- Doses:
- - 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Animals were not removed from cage during observation, unless necessary for identification or confirmation of possible findings. Postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. The observation period was 14 days. All the animals were examined for reaction to dosing. The onset, intensity and duration of these signs was recorded (if appropriate), particular attention being paid to the animals during and for the first hour after dosing. Animals were weighed individually on Days 1 (predose), 8 and 15.
- Necropsy of survivors performed: yes
- Clinical signs including body weight : yes
- Other examinations performed: clinical signs, body weight, gross pathology, irritation.
The skin reactions were assessed at approximately 24, 48 and 72 hours after the removal of the dressing and test item. Adjacent areas of untreated skin of each animal served as controls. - Statistics:
- No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
- Preliminary study:
- None.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred at 2000 mg/kg.
- Clinical signs:
- other: No clinical signs of systemic toxicity were noted.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- Focal erythema, scales, scabs and/or necrosis was noted at the treated skin of the animals throughout the observation period. These local effects were considered not indicative of systemic toxicity.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value of MTDID 18990 in Wistar Han rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
The acute dermal lethality potential of MTDID 18990 was evaluated in Wistar rats. The study was conducted according to OECD 402, in compliance with OECD GLP. Rats (3 female) received a single dermal application of 2000 mg/kg MTDID 18990; the test article was applied to clipped skin and held in contact with the body with surgical gauze covered with a Coban elastic bandage for 24 hours. All three rats survived the exposure period and subsequent 14-day recovery period. Focal erythema, scales, scabs and/or necrosis were noted at the treatment sites of the animals, but those were not considered indicative of systemic toxicity. No clinical signs of adverse systemic toxicity were observed. The rat dermal LD50 is>2000 mg/kg of body weight in rats.
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