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EC number: 916-533-5 | CAS number: -
- 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:
- 06 December 2011 to 09 December 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 2-1-4
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of l-Glutamic acid, N-coco acyl derivs., disodium salts and l-Glutamic acid, N-coco acyl derivs., monosodium salts
- EC Number:
- 916-533-5
- Molecular formula:
- R-C6H6NO5Na2, R-C6H7NO5Na R: Coco fatty acid residue
- IUPAC Name:
- Reaction mass of l-Glutamic acid, N-coco acyl derivs., disodium salts and l-Glutamic acid, N-coco acyl derivs., monosodium salts
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: White to pale yellow powder with a slightly characteristic odour.
- Storage condition of test material: room temperature (15-25 ºC) in the dark.
- pH: 6.5.
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: 12 weeks old males.
- Weight at study initiation: 3120 – 3146 g
- Housing: Individually in metal wire rabbit cages.
- Diet: Commercial feed, ad libitum.
- Water: Municipal tap water, ad libitum.
- Acclimation period: 13 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.1 to 20.7 °C
- Humidity (%): 24 to 60 %
- Air changes (per hr): 15 to 20 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light per day, from 06:00 to 18:00 hours.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after treatment.
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: A 6 cm² area on the back and flank of each animal.
- Type of wrap if used: A single layer of fine medical gauze (open-weave with large holes) of approximately 5 x 5 cm was placed over the application area. The appropriate amount of test material was carefully spread over the application area (the gauze helped maintain the test item in place). Three more layers of gauze were placed over the test material. These gauze patches were kept in contact with the skin by a patch of clear plastic with a surrounding adhesive hypoallergenic plaster to ensure continued good contact between the moistened test material and the shaved skin. The entire trunks of the animals were wrapped with plastic wrap, kept in place with medical elastic tubing.
REMOVAL OF TEST SUBSTANCE
- Washing: The test material was removed with water at body temperature.
- Time after start of exposure: 4 hours.
OBSERVATIONS
- Dermal reaction: Animals were examined for signs of erythema and edema at 60 minutes and then at 24, 48 and 72 hours after patch removal. Animals were observed for a sufficient amount of time to assess reversibility of any observed effects.
- Clinical signs: Recorded daily.
- Body weights: Recorded at the beginning and at termination of the experiment.
SCORING SYSTEM: Dermal reactions were scored according to the Draize scale (1959), see Table 1.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - One hour after patch removal: Very slight erythema (score 1) was observed in two animals and very slight edema (score 1) was noted in one animal.
- 24, 48 and 72 hours after patch removal: There were no observed clinical signs noted on the skin of the treated animals.
- As no clinical signs were observed the study was terminated after the 72 hours observation. - Other effects:
- - Mortality: None observed during the study.
- Clinical: No treatment related clinical signs noted.
- Bodyweights: There was no effect of treatment on body weight. Body weights measured between 3184 and 3197g at termination.
Any other information on results incl. tables
Table 2: Erythema Formation Results
Animal No. |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
1 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
3 |
1 |
0 |
0 |
0 |
Total |
2 |
0 |
0 |
0 |
Table 3: Edema Formation Results
Animal No. |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
1 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
Total |
1 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Very slight erythema (score 1) was observed in two animals and very slight edema (score 1) was noted in one animal one hour after application of the test material. By 24 hours all effects were fully reversible. Under the conditions of the test, the test material was determined to be non-irritating.
- Executive summary:
The potential for the test material to cause skin irritation was determined in vivo, in a study conducted under GLP conditions and in line with OCED 404, EU Method B.4, EPA OPPTS 870.2500 and Japanese MAFF (2-1-4). The test material was administered to three male New Zealand White rabbits and occluded for 4 hours, after which the test material was removed by washing with water. Dermal reactions were assessed at 1, 24, 48 and 72 hours post removal. Clinical observations were recorded daily and bodyweights were measured at initiation and termination.
Very slight erythema (score 1) was observed in two animals and very slight edema (score 1) was noted in one animal one hour after application of the test material. By 24 hours all effects were fully reversible. Under the conditions of the study, the test material was determined to be non-irritating.
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