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EC number: 627-132-7 | CAS number: 1227096-04-9
- 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:
- from 1988-02-09 to 1988-03-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Reliability scoring based on 1981 guideline for test n°404
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- EC Number:
- 627-132-7
- Cas Number:
- 1227096-04-9
- Molecular formula:
- No molecular formula
- IUPAC Name:
- N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- Test material form:
- liquid
- Details on test material:
- - Chemical name: N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- EC number: 627-132-7
“Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree 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
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.5-3.5 kg
- Diet and water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature : 17-23 °C
- Humidity: 30-70 %
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: each animal served as its own control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 min, 60 min, 24, 48, 72 hrs and 7d, 14d, 21d after removal the patch
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: skin of the back
- % coverage: 2.5 cm x 2.5 ccm
- Type of wrap if used: semi-occlusive
SCORING SYSTEM: according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- For raw data see table 1 in the "remarks on results" freetext.
Any other information on results incl. tables
Moderate to severe erythema and very slight oedema were observed for up to 72 hours after removal of the dressing. Erythema and oedema had reversed by day 14 and 7, respectively. At the end of the observation period (21 days), 1 animal had still alopecia.
No ulceration or necrosis was observed.
Table 1 Individual skin irritation scores according to the OECD 404 guideline
Erythema |
Oedema |
|||||
Animal No |
1 |
2 |
3 |
1 |
2 |
3 |
After |
3 |
2 |
2 |
1 |
1 |
1 |
After 24 h |
3 |
2 |
2 |
1 |
1 |
0 |
After 48 h |
3 |
1 |
2 |
1 |
1 |
1 |
After 72 h |
3 |
1 |
2 |
1 |
1 |
1 |
Mean score 24-72 h |
2.1 |
0.9 |
||||
Day 7 |
2 |
1 |
1 |
0 |
0 |
0 |
Day 14 |
0 |
0 |
0 |
0 |
0 |
0 |
Day 21 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Directive 67/548/EEC
- Conclusions:
- Under these experimental conditions and according to directive 67/548/EEC, the tested substance Genamin SH 301 is classified as a skin irritant.
- Executive summary:
The potential of Genamin SH 301 to induce skin irritation was assessed in 3 rabbits according to the OECD guideline 404 and in compliance with the principles of Good Laboratory Practice regulations.
A single dose of 0.5 mL undiluted Genamin SH 301 was applied to the skin of the rabbits under a semi-occlusive dressing for a 4-hour exposure period. Skin reactions were observed approximately 0.5/1 hour, 24, 48 and 72 hours after removal of the dressing and then on day 7, 14 and 21 in order to observe their reversibility. The mean values of the scores for erythema and oedema were calculated for each animal.
The mean scores over 24, 48 and 72 hours for individual animals were 3.0, 1.3, and 2.0 for erythema and 1.0, 1.0, and 0.7 for edema. No ulceration of necrosis was noted. Erythema and edema had reversed by day 14 and by day 7, respectively.
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