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EC number: 295-835-2 | CAS number: 92129-33-4
- 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:
- From 1986-02-11 to 1986-02-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dimethyldioctadecylammonium chloride
- EC Number:
- 203-508-2
- EC Name:
- Dimethyldioctadecylammonium chloride
- Cas Number:
- 107-64-2
- Molecular formula:
- C38H80N.Cl
- IUPAC Name:
- N,N-dimethyl-N-octadecyloctadecan-1-aminium chloride
- Reference substance name:
- 1-octadecanamium,N,N-dimethyl-N-octadecyl-,chloride
- IUPAC Name:
- 1-octadecanamium,N,N-dimethyl-N-octadecyl-,chloride
- Reference substance name:
- Dimethyldioctadecylammonium choride
- IUPAC Name:
- Dimethyldioctadecylammonium choride
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.2-3.4 kg
- Housing: individually
- Diet: ad libitum
- Water : ad libitum
- Acclimation period: 1 week prior to the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 50±20%
- Photoperiod : 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- other: each animal served as its own control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.5 g
- Concentration (if solution):
VEHICLE
- Amount(s) applied : 0.9ml isotonic saline.
0.5 g test substance pasted with 0.9 ml isotonic saline. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 min, 60 min, 24, 48, 72 hrs and 7d, 14d after removal the patch
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: skin of the back
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed from skin with warm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline 404 (draize scoring system)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- For raw data see table 1 in the "remarks on results" freetext.
30-60 minutes and 24 hours after patch removal the animals showed very slight to well defined erythema. 48 hours to 7 days after patch removal two rabbits showed a very slight or well defined erythema. 14 days after application erythema and oedema formation were reversed. Additionally, the treated skin areas were sporadically dry-rough, discoloured light brown and fine or coarse scaly during the observation period.
Any other information on results incl. tables
Table 1 Individual skin irritation scores according to the OECD 404 guideline
Time after patch removal |
30-60 minutes |
24 h |
48 h |
72 h |
7 d |
14 d |
||||||||||||
Animal no. |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
erythema |
2 |
1 |
1 |
2 |
1 |
1 |
2 |
1 |
0 |
2 |
1 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
skin surface |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- dry rough |
|
|
|
|
|
x |
x |
|
x |
x |
x |
x |
x |
x |
x |
x |
x |
|
- fine scaly |
|
|
|
|
|
x |
|
|
|
|
|
|
|
x |
|
|
x |
|
- coarse scaly |
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
x |
|
|
- large disol. light brown |
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC
- Conclusions:
- Under the experimental conditions of this study and according to the criteria laid down in CLP (Reg 1272/2008/EC) and directive 67/548/EEC, the test item dimethyldioctadecylammonium chloride (purity 97%) is not classified.
- Executive summary:
The potential of Dimethyldioctadecylammonium chloride (purity 97%) to induce skin irritation was assessed in 3 rabbits according to the OECD guideline 404 and to the EU Method B.4. The study was conducted in compliance with the principles of Good Laboratory Practice regulations.
A single dose of 0.5 g pasted with 0.9 ml isotonic saline 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 , 24, 48 and 72 hours after removal of the dressing and then on day 7, 14 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 2.0, 1.0, and 0.3 for erythema and 0.0, 0.0, and 0.0 for oedema and all reactions reversed within 14 days. Oedema were not observed. In addition, the treated skin sites were sporadically dry-rough, discoloured light brown and fine or coarse scales occurred during the observation period of 14 days. Based on the study results, the test material is not subject to labelling requirements with regard to skin irritation..
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