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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 629-721-4 | CAS number: 308062-60-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 23-Sep-2009 to 06-Oct-2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- An In vivo study was performed for this substance, since fatty amine based substances frequently produces false negative results for irritation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(C16-C18)alkyl(C16-C18)alkane-1-amine
- EC Number:
- 629-721-4
- Cas Number:
- 308062-60-4
- Molecular formula:
- No molecular formula
- IUPAC Name:
- N-(C16-C18)alkyl(C16-C18)alkane-1-amine
- Test material form:
- solid
- Details on test material:
- Chemical name: Amines, di-C16-18 (even numbered) alkyl
EC no.: 629-721-4
To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals: Young Adult New Zealand White Rabbit, SPF
Rationale: Recognized by international guidelines as a recommended test system.
Breeder: Harlan France ZI Le Malcourlet 03800 Gannat / France
Number of Animals per Test: 3 (Animals of both sexes were used)
Age (when treated): 16 weeks (male), 16 weeks (females)
Body Weight Range (when treated): 2794 g (male), 2534 - 2888 g (females)
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
The animals were distributed as follows: Male Number 96, female numbers 97 and 98
Husbandry:
Room Number: 0501 / Harlan Laboratories Ltd., Füllinsdorf
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously
monitored environment with ranges for room temperature 17-23 °C and for relative humidity between 30-70% (values above 70% during cleaning
process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (Harlan Laboratories Ltd,Füllinsdorf) and haysticks 4642 (batch no. 69/08, Provimi Kliba AG) were provided for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch nos. 44/09 and 52/09) provided by Provimi Kliba AG, 4303
Kaiseraugst/ Switzerland. Results of analysis for contaminants are archived at Harlan Laboratories Ltd.
Water: Community tap water from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant
analyses are archived at Harlan Laboratories Ltd.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g (per animal) of Amines, bis(hydrogenated tallow alkyl) (CAS number: 61789-79-5) was weighed and applied undiluted as it was delivered by the Sponsor.
- Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 7 days after instillation
- Number of animals or in vitro replicates:
- 1 male
2 females - Details on study design:
- REMOVAL OF TEST ITEM:
- Washing (if done): no washing done
SCORING SYSTEM:
according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5. Data were summarized in tabular form, showing for each individual animal the irritation scores for the designated observation time, a description of the degree and nature of irritation, the
presence of serious lesions and non-ocular effects. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values (with the exception of the sclerae) for each type of lesion.
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG, 4153 Reinach /
Switzerland).Varta Cliptrix diagnostic-lamp (Roth AG, 4153 Reinach / Switzerland).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: individual mean scores: 0 - 0 - 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effects observed
- Remarks on result:
- other: individual mean scores: 0 - 0 - 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.56
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours to 7 days after instillation
- Remarks on result:
- other: individual mean scores: 2.00 - 1.00 - 1.67
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- other: no effects in one animal, fully reversible in the two other animals 48 to 72 hours after instillation
- Remarks on result:
- other: individual mean scores: 0.33 - 0.00 - 0.67
- Other effects:
- No staining produced by the test item of the treated eye was observed.
White test item remnants were observed in the treated eye or conjunctival sac of all three animals at the 1-hour reading and persisted up to the 24-hour reading in the male and one female.
Slight ocular discharge was present at the 1-hour observation in all animals and lasted up to the 24-hour reading in one female.
Slight to moderate reddening of the sclerae was noted at the 1-hour observation after instillation in all three animals and persisted until the 48-to 72-hour reading .
Any other information on results incl. tables
The instillation of Amines, bis(hydrogenated tallow alkyl) (CAS number: 61789-79-5) into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis.
Slight to moderate reddening of the conjunctivae was noted at the 1-hour observation after instillation in all three animals and persisted as marked to slight until the 72-hour reading (one male) or as moderate to slight until the 48- or 72-hour reading (both females). At the same time, slight to moderate reddening of the sclerae was also observed in all three animals. Slight swelling (chemosis) of the conjunctivae was observed in the male and one female at the 24-hour reading and persisted until the 48-hour reading in the female. Slight ocular discharge was present at the 1-hour observation in all animals and lasted up to the 24-hour reading in one female.
No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the end of the observation period for all animals.
No necropsy was performed at the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification criteria (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008), Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) is not classified and therefore considered “not irritating” to the rabbit eye.
- Executive summary:
The primary eye irritation potential of Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well
as 7 days after test item instillation.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 2.00, 1.00 and 1.67 for reddening and 0.33, 0.00 and 0.67 for chemosis, respectively.
The instillation of Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. White staining of the treated eyes by the test item was observed. No clinical signs were observed.
Thus, the test item did not induce significant or irreversible damage to the rabbit eye.
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.