Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 800-153-0 | CAS number: 1313206-64-2
- 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:
- weight of evidence
- Study period:
- 1997-03-28 to 1997-09-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The assay was performed on a mixture containing 2-butoxyethanol (CAS 111-76-2) and no formal analytical certificate was available as the product was in phase of development at that time.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Minor fluctuations of relative humidity recorded outside of the target ranges specified in the protocol were not considered to have an impact on the validity or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see above
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amines,N-(C16-18 and C18 unsaturated alkyl) trimethylenedi-,diacetates.
- EC Number:
- 800-153-0
- Cas Number:
- 1313206-64-2
- Molecular formula:
- R-NH2+ -(CH2)3-NH3+, (CH3 COO-)2 where R = C16-18 and C18-unsat alkyl
- IUPAC Name:
- Amines,N-(C16-18 and C18 unsaturated alkyl) trimethylenedi-,diacetates.
- Reference substance name:
- 2-butoxyethanol
- EC Number:
- 203-905-0
- EC Name:
- 2-butoxyethanol
- Cas Number:
- 111-76-2
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 2-butoxyethanol
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
- Details on test material:
- Chemical registery number : 1313206-64-2
Chemical name : Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, diacetates
Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agreed by each registrant.
1
2
3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2.4 +/- 0.2 kg.
- Housing: individually in polystyrene cages (35 cm x 55 cm x 32 cm or 48.2 cm x 58 cm x 36.5 cm)
- Diet (e.g. ad libitum): at libitum (112 C pelletet diet, UAR, Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum drinking water filtered by F.G. Millipore membrane (0.22 micron)
- Acclimation period: at least five days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/-3
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: 01 April 1997 To: 15 April 1997
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72h after patch removal; animals were observed daily for reversibility of irritating effects up to day 14
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: right flank of the animals
- % coverage: approximately 6 cm2
- Type of wrap if used: dry gauze pad held in contact by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Erythema and eschar formation:
. no erythema ........................................................................................................... 0
. very slight erythema (barely perceptible) .............................................................. 1
. well-defined erythema........................................................................................... 2
. moderate to severe erythema................................................................................. 3
. severe erythema (beet redness) to slight eschar formation (injuries in depth) ...... 4
Oedema formation
. no oedema ............................................................................................................. 0
. very slight oedema (barely perceptible) ................................................................ 1
. slight oedema (edges of area well-defined by definite raising)............................. 2
. moderate oedema (raised approximately 1 millimetre)......................................... 3
. severe oedema (raised more than 1 millimetre and extending beyond area
of exposure)........................................................................................................... 4
Any other lesions was noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 Days in 1/3 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 Days in 1/3 animals
- Irritant / corrosive response data:
- On day 1, a well-defined erythema (grade 2) and a severe oedema (grade 4) were noted in all animals. A severe erythema (grade 4) and a severe oedema (grade 4) were observed in all animals from day 2 up to day 5. A very slight to severe erythema (grades 1 to 4) was then noted up to day 11 (one animal), 14 (one animal) or up to the end of the observation period (day 15, in the remaining animal). A severe oedema (grade 4) was observed in one animal from day 11 up to day 15.
Necrosis was recorded in all animals on days 2 and 3, then crusts were observed in all animals from day 4 up to day 9 or 10. Dryness of the skin was noted in two animals, from day 10 or 12 up to the end of the observation period (day 15).
Mean scores over 24, 48 and 72 hours for individual animal were 4.0, 4.0 and 4.0 for erythema and 4.0, 4.0 and 4.0 for oedema.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Amines,N-(C16-18 and C18 unsaturated alkyl) trimethylenedi-,diacetates is considered as a skin irritant cat. 2
- Executive summary:
The potential of the test item (38% n-tallow alkyltrimethylene diamines, diacetates, mixed with 25% butyl glycol and 37% water) to induce skin irritation was evaluated in rabbits according to OECD (No. 404, 17th July 1992) and EC (92/69/EEC, B.4, 31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.
The test item was applied for a period of 4 hours to three male New Zealand White rabbits at a dose-volume of 0.5 mL (undiluted) to the closely-clipped skin of one flank. The test item was held in contact with the skin by means of a semi-occlusive dressing.
Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until the end of the observation period (day 15). The mean values of the scores for erythema and oedema were calculated for each animal. On day 1, a well-defined erythema (grade 2) and a severe oedema (grade 4) were noted in all animals. A severe erythema (grade 4) and a severe oedema (grade 4) were observed in all animals from day 2 up to day 5. A very slight to severe erythema (grades 1 to 4) was then noted up to day 11 (one animal), 14 (one animal) or up to the end of the observation period (day 15, in the remaining animal). A severe oedema (grade 4) was observed in one animal from day 11 up to day 15.Necrosis was recorded in all animals on days 2 and 3, then crusts were observed in all animals from day 4 up to day 9 or 10. Dryness of the skin was noted in two animals, from day 10 or 12 up to the end of the observation period (day 15).
Mean scores over 24, 48 and 72 hours for individual animals were 4.0, 4.0 and 4.0 for erythema and 4.0, 4.0 and 4.0 for oedema.
Under these experimental conditions, the test item is considered to be severely irritant for skin when applied topically to rabbits.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.