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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 607-854-9 | CAS number: 2605-78-9
- 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:
- key study
- Study period:
- between 28th November 2007 and 25th December 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Schedule 1 (Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by 2004/0994))
Test material
- Reference substance name:
- N,N-dimethyl-N-octylhydroxylamine
- EC Number:
- 607-854-9
- Cas Number:
- 2605-78-9
- Molecular formula:
- CH3(CH2)7N(CH3)2O
- IUPAC Name:
- N,N-dimethyl-N-octylhydroxylamine
- Reference substance name:
- Dimethyl(octyl)amine
- EC Number:
- 230-939-3
- EC Name:
- Dimethyl(octyl)amine
- Cas Number:
- 7378-99-6
- Molecular formula:
- C10H23N
- IUPAC Name:
- N,N-dimethyloctan-1-amine
- Reference substance name:
- Methanol
- EC Number:
- 200-659-6
- EC Name:
- Methanol
- Cas Number:
- 67-56-1
- Molecular formula:
- CH4O
- IUPAC Name:
- Methanol
- Test material form:
- liquid: viscous
Constituent 1
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- - Analytical purity: 82.3%
- Purity test date: Not available
- Lot/batch No.: GN-8
- Expiration date of the lot/batch: Not available
- Appearance: Amber coloured, extremely viscous liquid
- Storage: In the dark at room temperature
- Additional information on test material used for the study: It was attempted to purify the substance to a purity of >80% by using an alternative synthetic route, as opposed to the usual commercial route of synthesis which results in a purity of the substance of approximately 40% in water. This alternative synthetic route generated the substance at 82.3% purity, however it also generated an impurity (methanol at 4.0%) which is not present in the commercial substance. Based on the classification and labelling of methanol, it is considered that this additional impurity would not have an influence on any of the endpoints discussed in this dossier other than the acute oral toxicity study. Therefore all studies (including the one covering this endpoint) contained in this dossier (other than the acute oral toxicity study) were conducted on the 82.3% pure substance containing the 4.0% methanol impurity. The acute oral toxicity study has been conducted on the commercially generated substance at a purity of approximately 40% in water.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Uk Limited, Bicester, Oxan UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.0-3.5 kg
- Housing: Individually housed in suspended cages.
- Diet: Ad libitum, Certified rabbit diet (both water and food were considered not to contain any contaminent of a level which would affect the results of the test.)
- Water: Ad libitum, free access to mains water
- Acclimation period: 5 days
- pH: pH determined at 6.9-7.0
ENVIRONMENTAL CONDITIONS
- Temperature : 17-23°C
- Humidity : 30-70%
- Air changes: 15 changes per hour
- Photoperiod: 12 hours continous light and 12 hours continual dark.
Animals were provided with environmental enrichment items which did not contain any contaminents to a level that would affect the results of the test.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5ml of test material was applied to the three test sites.
- Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours.
- Observation period:
- 3 days (extended to 7 and 14 days to assess reversibility)
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Flank and Dorsal
- % coverage: 30%
- Type of wrap if used: semiocclusive elasticated corset wrap
REMOVAL OF TEST SUBSTANCE
- Washing : Test material removed from test area via gentle swabbing of the test areas with cotton wool soaked in distilled water.
- Time after start of exposure: 3 minutes, 1 hour and 4 hours.
SCORING SYSTEM:
Evaluation of Skin Reactions:
Erythema and Eschar Formation
No erythema = 0
Very slight erythema (barely perceptible) = 1
Well defined erythema = 2
Moderate to severe erythema =3
Severe erythema (beef redness to eschar formation preventing grading of erythema = 4
Oedema Formation
No oedema = 0
Very slight oedema (barely perceptible) = 1
Slight oedema (edged 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 the area of exposure) = 4
Any other skin reactions, if present, were also recorded.
Additional observations were made on Days 7 and 14 to assess the reversibility of skin reactions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hour
- Score:
- 2.7
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- The primary irritation index of the test material was determined to be 2.7 and was therefore classified as a MODERATE IRRITANT. However it was discovered not to be corrosive.
- Other effects:
- Loss of elasticity was noted at the treated skin site at the 72 hour observation and slight desquamation was noted at the 7 day observation.
Any other information on results incl. tables
D = Slight desquamation Le = Loss of skin elasticity
( ) = Total values not used for calculation of primary irritation index - = Observation not required Cf = Crust formation D = Slight desquamation Le = Loss of skin elasticity Lf = Loss of skin flexibility
On day 14 one treatment site had recovered. |
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize classification scheme
- Conclusions:
- The test material was determined to be a Moderate Irritant to Rabbit skin. With a Primary irritation index of 2.7
- Executive summary:
Introduction: The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
- OECD Guidelines for the testing of Chemicals No 404 " Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)
- Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC
Results: 3 -minute and 1 -hour semi occluded applications of the test material to the intact of one rabbit produced no corrosive effects.
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced well defined erythema and very slight oedema. Crust formation, slight desquamation and loss of skin flexibility and/or elasticity were also noted. One treated skin site apperaed normal at the 14 -day observation. No corrosive effects were noted.
Conclusion: The test material produced a primary irritation index of 2.7 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies