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EC number: 204-690-6 | CAS number: 124-22-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 404 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dodecylamine
- EC Number:
- 204-690-6
- EC Name:
- Dodecylamine
- Cas Number:
- 124-22-1
- Molecular formula:
- C12H27N
- IUPAC Name:
- dodecan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): Genamin 12R 100 D
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Abbaye de Bellefontaine (49122 Bégrolles en Mauges, France)
- Age at study initiation: about 3 -5 months
- Weight at study initiation: 2.6 +- 0.1 kg
- Housing: conventional air-conditioned rooms, individually in polycarbonate cages. Each cage was equipped with a food container and a water bottle
- Diet (e.g. ad libitum): ad libitum (certified pellet Rabbit diet: lapins entretien Reference 112 C; U.A.R. 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum (tap-water, filtered by membrane of .22micron (millipore)
- Acclimation period:
- min. 7 days
- daily observation during acclimation period
- preventive treatment for coccidiosis by administration of a Mucoxid solution at the dose level of 140 mg/kg/d (Veda-Cogla, 45140 Saint Jean de l a Ruelle, France) to their drinking water fpr 5 days during acclimatization period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3 °C
- Humidity (%): 50 +-20 %
- Photoperiod (hrs dark / hrs light): 12/12
- incoming non-recylced air was filtered
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- 3 min
Then test substance was removed from the skin with water (3 animals) or with 3 % acetic acid solution followed by rinsing with water (3 animals) - Observation period:
- 14 days
- Number of animals:
- 6 males (3 animals rinsed with water, 3 animals rinsed with 3% acetic acid solution)
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm^2
- % coverage: 100 %
A dose of 500mg was applied to a Codex hydrophilic gauze patch of 6cm^2. this was applied to the right flank of each animal. The left flank which remains untreated served as a control
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with tap water or 3% acetic acid solution followed rinsing with water
- Time after start of exposure: 3 min.
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 (lesion in depth).........4
Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- necrosis noted from 24 h reading time point
- Remarks on result:
- other: 3 minute exposure followed by rinsing with water
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks:
- necrosis noted from 24 hour reading time point
- Remarks on result:
- other: 3 minute exposure followed by rinsing with water
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 3 minute exposure followed by rinsing with water
- Irritation parameter:
- edema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: necrosis noted from 24 hour reading time point proved to be reversible in only one animals
- Remarks on result:
- other: 3 minute exposure followed by rinsing with water
- Irritation parameter:
- erythema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 3 minute exposure followed by rinsing with 3% acetic acid
- Irritation parameter:
- edema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 3 minute exposure followed by rinsing with 3% acetic acid
- Irritant / corrosive response data:
- The test material proved to be corrosive following a 3 minute exposure period with subsequent rinsing with water. However, severe irritating but no corrosivity was observed when rinsing was performed with 3% acetic acid solution instead of water.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material Genamin 12R 100D proved to be corrosive to skin following an exposure period of 3 minutes and subsequent rinsing with water. However, when rinsing was performed with 3% acetic acid solution instead of water, severe irritating effects but no corrosivity was observed.
- Executive summary:
In a GLP conform study, Genamin 12R 100 D was tested for skin irritation / corrosion according to OECD test guideline 404. for this 0.5 g of undiluted Genamin 12R 100D was applied semi-occlusively for 3 minutes to the shaved skin of six New Zealand White rabbits. To examine whether the rinsing procedure may have an influence on the skin irritative properties of this highly alkaline product, subsequent rinsing was performed with water (3 animals) and 3% acetic acid solution followed by water (3 animals) The skin of all animals then was examined 30 minutes, 1 hour, 24, 48 and 72 hours post exposure. Since effects were still present after 72 hours, additional readings were performed up to day 14.
One hour after removal of the dressing, the cutaneous reactions were marked; a slight to moderate erythema and a severe oedema were observed. No difference was noted between the two rinsing procedures for the animals.
An epidermal necrosis was noted quickly in the animals rinsed with water (24 h), which appeared delayed on Day 4 (1 animal) and 5 (2 animals) when the skin was rinsed with a 3% acetic acid solution, then water. Recovery developed in all animals rinsed with acetic acid solution. The skin was normal but dry in 2 animals on Day 10 and in the last animal on Day 14, when rinsing was performed with a 3% acetic acid solution, when water. The recovery occurred only in 1 animal when rinsed with water on Day 14. An epidermal necrosis was still present in 2 out of 3 animals rinsed with water at the end of the observation period
No oedema was observed in the animals from Day 7, for both rinsing procedures
Under our experimental conditions, the test substance Genamin 12R 100 D was corrosive. Severe cutaneous reactions leading to epidermal necrosis was seen earlier with rinsing the skin with water than with rinsing with 3% acid solution, then water. This latter procedure allowed a more rapid replacement of the necrotized epidermis than the former; this took 10 and 14 days respectively. Oedema which was severe in all animals after application of the test substance disappeared completely within 7 days. Based on the criteria laid down in the Directive 83/467/EEC, Genamin 12R 100 D has to be labelled as corrosive (C) with the designation R 35 — causes severe burns.
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