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EC number: 434-630-6 | CAS number: 60372-77-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 8, 2000 to February 2, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- A guideline study with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed before the entry into force of REACH Regulation.
Test material
- Reference substance name:
- -
- EC Number:
- 434-630-6
- EC Name:
- -
- Cas Number:
- 60372-77-2
- Molecular formula:
- Hill formula: C20H41N4O3Cl
- IUPAC Name:
- ethyl N2-dodecanoyl-l-argininate hydrochloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: Nα-Lauroyl-L-arginine ethyl ester monohydrochloride
- Substance type: Dehydrated LAE
- Physical state: Granular white powder
- Lot/batch No.: 2625
- Purity: 92-94%
- Storage condition of test material: 4ºC, protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Nossan S.r.l., Correzzana (MI), Italy
- Age at study initiation: 4 to 5 weeks
- Weight at study initiation: 300-350 g
- Housing: in groups of up to 5 animals, in stainless steel cages measuring 48 x 63 x 41 cm with a grid floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 45 to 65%.
- Photoperiod (hrs dark / hrs light): artificial cycle of 12 hours light/12 hours dark
IN-LIFE DATES: From: May 2, 2000 To: May 25, 2000
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1 %
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 20%
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- RANGE FINDING TESTS:
- Intradermal injection tolerance test: Two animals were selected from those available. Six sites were selected on each animal and these injected intradermally with 0.1 ml single concentration of the test item. The 2 animals were treated with the substance at concentrations of 50%, 20%, 10%, 5%, 1% and 0.5% in sterile water. The treated sites were examined 5 days later for any signs of reaction to treatment. Observed irritation was recorded using the Draize scoring scale (below) and any response not covered by the scoring scale was separately described.
- Topical application tolerance test: Five animals were selected from those available and each of them injected intradermally at the prepared site with two injections, each of 0.1 ml, of emulsified Freund's complete adjuvant. Seven days later, the flanks of each animal were clipped free of hair and dosed with 2 concentrations of the test item, 1 on either flank. All animals were treated in this manner such that a total of 5 concentrations of the test item (50%, 20%, 10% 5% and 1% in sterile water). Within the group, each concentration was duplicated. The adhesive dressings and gauze patches were removed after 24 hours contact with the skin.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2: Intradermal injectionand topical application
- Exposure period: 7 days intradermal injection; 48 hours topical application
- Test group: 1 test group of 10 animals
- Control group: 5 animals
- Site: scapular region
- Frequency of applications: Intradermal injection (day 0); topical application (day 8)
- Duration: 21 days
- Concentrations: 0.1% intradermal injection; 20% topical application
B. CHALLENGE EXPOSURE
- No. of exposures: Challenge exposure topical application (1)
- Day(s) of challenge: 2
- Exposure period: 24 hours
- Test group: 1 test group of 10 animals
- Control group: 5 animals
- Site: flanks
- Concentrations: 5%
- Evaluation (hr after challenge): 3, 24 and 48 hours - Positive control substance(s):
- yes
- Remarks:
- (mercaptobenzothiazole)
Results and discussion
- Positive control results:
- 70% response in test group and 0% response in control group at challenge. Incidence at challenge is acceptable. Test system is regarded as valid.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 5 %
Signs of irritation during induction:
Intradermal injection: Well defined erythema was apparent
following administration of Freund's complete adjuvant, the
vehicle or the test substance mixed with Freund's complete
adjuvant. Slight reaction was seen in five animals at both
sites treated with the test substance. No reaction was
observed at those sites following 48 hours topical exposure to test item
or vehicle alone.
Topical application: No reaction was observed around the
injection sites of animals following topical exposure to the
test substance or the vehicle alone.
Evidence of sensitisation of each challenge concentration:
No response was observed in any animal.
Other observations:
Changes in bodyweight of animals during the study period
were generally similar in animals from both the test and control groups.
Table 1. Details on main study Challenge individual results:
Dermal response | ||||||
Vehicle | Test item | |||||
Group function | Animal |
Sex |
24 h |
48 h |
24 h |
48 h |
CONTROL | 221 | Female | 0 |
0 |
0 |
0 |
223 |
0 |
0 |
0 |
0 |
||
225 |
0 |
0 |
0 |
0 |
||
227 |
0 |
0 |
0 |
0 |
||
229 |
0 |
0 |
0 |
0 |
||
TEST |
231 |
0 |
0 |
0 |
0 |
|
233 |
0 |
0 |
0 |
0 |
||
235 |
0 |
0 |
0 |
0 |
||
237 |
0 |
0 |
0 |
0 |
||
239 |
0 |
0 |
0 |
0 |
||
241 |
0 |
0 |
0 |
0 |
||
243 |
0 |
0 |
0 |
0 |
||
245 |
0 |
0 |
0 |
0 |
||
247 |
0 |
0 |
0 |
0 |
||
249 |
0 |
0 |
0 |
0 |
Erythema and Eschar Formation Value |
|
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 |
|
(injuries in depth) |
4 |
Oedema Formation |
|
No oedema |
0 |
Very slight oedema (barely perceptible) |
1 |
Slight oedema (edges of area well-defined by definite raising) |
2 |
Moderate oedema (raised approximately 1 millimetre) |
3 |
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) |
4 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained in this study indicate that LAE does not elicit a sensitisation reponse in the guinea pig, as no reaction was observed at challenge.
- Executive summary:
The study was performed according to OECD 406 guideline and in agreement with those of B.6 detailed in Commision Directive 96/54/EEC.
The results obtained in this study indicate that LAE does not elicit a sensitisation response in the guinea pig, there being no reaction observed at challenge. LAE is not sensitising to skin and has not to be classified for skin sensitisation.
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