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EC number: 202-608-3 | CAS number: 97-78-9
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 25 Oct - 17 Nov 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium N-lauroylsarcosinate
- EC Number:
- 205-281-5
- EC Name:
- Sodium N-lauroylsarcosinate
- Cas Number:
- 137-16-6
- IUPAC Name:
- sodium [dodecanoyl(methyl)amino]acetate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: colourless liquid
- Analytical purity: 30% in water
- Impurities (identity and concentrations): conditional on production the product still contains really approx. 1-2% Natrium-laurat)
- Lot/batch No.: 4165892
- Storage condition of test material: room temperature
- Other:
pH: (10%) = 7.5 - 9.0
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: LIttle russian, Chbb:HM(SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DIMEO Schonwalde GmbH, Schonwalde, Germany and stock Chbb:HM from Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: approx 13 - 15 months
- Weight at study initiation: 2.5 - 2.6 kg
- Housing: During a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 cm²) with perforated floor.
- Diet: pelleted complete rabbit diet "Altromin 2123", ad libitum.
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 30% in water - Duration of treatment / exposure:
- Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h - Observation period:
- 14 days
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: anterior area of the animal
- Type of wrap if used: The patch was placed on the appropriate anterior test field and secured semi-occlusively with adhesive Gothaplast tape (2.5 cm).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure time the patch was removed, the test field was marked and the treated skin was cleaned with mild soap and lukewarm water.
- Time after start of exposure:
Initial test: 3 min, 1 h and 4 h
Confirmatory test: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 30% (v/v) in water
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 30% (v/v) in water
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 30% (v/v) in water
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 30% (v/v) in water
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: 30% (v/v) in water
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: 30% (v/v) in water
- Irritant / corrosive response data:
- Initial test:
The animal showed a well defined erythema on the posterior right test field immediately after the application.
Main test:
1 h after the termination of exposure a well defined erythema was observed on the posterior right test field of animal No. 2784. Animals No. 2865 and No. 2866 showed a very slight erythema on the anterior right test fields. 24, 48 and 72 h after the termination of exposure a very slight erythema was observed on the middle right test field of animal No. 2784 as well as a moderate to severe erythema and a very slight oedema on the posterior right test field. Animals No. 2865 and No. 2866 showed a very slight erythema on the anterior right test field. 7 days after the termination of exposure large scales were still observed on the whole posterior right test field of animal No. 2784. Animals No. 2865 and No. 2866 still showed isolated scales on the whole anterior right test fields.
14 days after the termination of exposure animals No. 2784, No. 2865 and No. 2866 were free of any signs of skin irritation. - Other effects:
- No further local or systemic effects were reported.
Any other information on results incl. tables
Table 1. Results of the initial irritation study.
Exposure time |
Erythema formation observed [h] |
Oedema formation observed [h] |
||||||||
0 |
1 |
24 |
48 |
72 |
0 |
1 |
24 |
48 |
72 |
|
3 min |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 h |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
Table 2. Results of skin irritation study.
Observation time |
Rabbit no. |
|||||||
1 |
2 |
3 |
||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|||
1 h |
2 |
0 |
1 |
0 |
1 |
0 |
||
24 h |
3 |
1 |
1 |
0 |
1 |
0 |
||
48 h |
3 |
1 |
1 |
0 |
1 |
0 |
||
72 h |
3 |
1 |
1 |
0 |
1 |
0 |
||
Mean value 24 + 48 + 72 h |
3,00 |
1,00 |
1,00 |
0,00 |
1,00 |
0,00 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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