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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30-09-1987 until 24-11-1987
- 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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see remarks below
- Principles of method if other than guideline:
- More animals tested than guideline.
Only 4 hr exposure tested. - GLP compliance:
- no
- Remarks:
- pre-GLP, but inhouse Quality Assurance
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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield rabbits, Peterfield, Hampshire, United Kingdom
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 2.0 - 2.8 kg
- Housing: individually in metal cage with perforated floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19
- Humidity (%): 30 - 70
- Air changes (per hr): 19 changes/hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g moistened with 0.5 ml distilled water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 0.5 hr after removal of patches and 24, 48 and 72 hours later. Additional observations were made on day 5 through 8.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5cm x 2.5 cm
- Gauze pad, occluded with Elastoplast elastic adhesive dressing (semi occlusive)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- see table below.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals 4 hrs exposure
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals 4 hrs exposure
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- At the end of the four hour exposure period very slight to moderate irritation was observed in all six animals. These reactions persisted
in five animals up to and including Day 6. The reactions had resolved completely in one animal by Day 2 and in three by Day 7.
Very slight erythema, accompanied in one animal by desquamation of the stratum corneum, persisted in two animals on Day 7, but had resolved
by the following day.
Any other information on results incl. tables
Summary of dermal lesions (following 4-h application)
no. |
Effect |
Hour |
Days after application |
Mean score erythema 24/48/72 h |
Mean score oedema 24/48/72 h |
|||||
0.5 |
1 |
2 |
3 |
4 |
5 |
6 |
||||
2636 |
Erythema/ eschar Oedema |
2 2 |
2 2 |
2 2 |
2 2 |
2 3 |
2 2 |
1D 0 |
2 |
2 |
2637 |
Erythema/ eschar Oedema |
2 2 |
2 3 |
2 3 |
2 1 |
2 2 |
2 1 |
0 0 |
2 |
2.3 |
2638 |
Erythema/ eschar Oedema |
1 1 |
1 1 |
1 1 |
1 0 |
1 1 |
1 1 |
0 0 |
1 |
0.7 |
2639 |
Erythema/ eschar Oedema |
2 3 |
2 3 |
2 3 |
3 2 |
3 2 |
2 2 |
1 0 |
2.3 |
2.7 |
2640 |
Erythema/ eschar Oedema |
2 1 |
2 1 |
2 1 |
2 1 |
1 1 |
1 1 |
0 0 |
2 |
1 |
2641 |
Erythema/ eschar Oedema |
2 1 |
0 0 |
0 |
0 |
|||||
Mean |
1.6 |
1.5 |
Fa = abnormal fur growth; Fr = reduced fur growth; D = desquamation; T = thickening of skin; R= reactions extending beyond treatment site; Hy = hyperkeratinisation; Br = brown discolourisation of skin; L = loss of skin suppleness; H = haemorrhage of dermal capillaries; Gr = green discoulorisation of skin; Tf = transverse folding of skin; Fi = fissuring of skin; Sc = small scattered scabs; Gs = glossy skin
On day 7 all scores were 0.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean erythema score was 2.3 for one animal. But majority of animals between 1.5 and 2.3.
The mean oedema score was for only two animals 2.3 and 2.7.
No signs of necrosis. Full reversibility. - Executive summary:
A study was performed to assess the effects of Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) on the irritancy potential to the skin of the New Zealand White rabbit. The method used was based on that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion".
A 4 hours, semi-occluded dermal application of the test material to the intact skin of three rabbits followed by a decontamination procedure with water produced irritation scores directly after patch removal and 1,2 and 3 days afterwards. The erythema/eschar effects were fully reversible within 7 days, the oedema effects were fully reversible in 6 days.
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