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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 October 2011 to 02 November 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:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 2-1-2
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adults.
- Weight at study initiation: 227 - 254 g.
- Housing: Individually in polypropylene/polycarbonate cages.
- Diet: Complete feed for rats and mice, ad libitum.
- Water: Municipal tap water, ad libitum.
- Acclimation period: 6 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15-20 air charges per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light, from 06:00 to 18:0 hours.
IN-LIFE DATES: From: 19 October 2011 To: 02 November 2011
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The back of each animal.
- % coverage: The test material was applied to the shaved skin. the test material was moistened with water and distributed as evenly as possible over an area of approximately 10 % of the total body area.
- Type of wrap if used: A gauze pad was placed over the applied test material. The gauze pad was fixed with a hypoallergenic plaster on the skin of the animals. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap.
REMOVAL OF TEST SUBSTANCE
- Washing: After exposure the treated area of skin was washed with water at body temperature.
- Time after start of exposure: 24 hours. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 per sex per dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
> Clinical Observations: Performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
> Bodyweights: Measured prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes were recorded.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No clinical signs were observed after the treatment with the test material or during the 14-day observation period. No local signs were observed after the treatment with the test material or during the 14-day observation period.
- Gross pathology:
- There was no evidence of the observations at a dose level of 2000 mg/kg bw at necropsy.
- Other findings:
- No local dermal signs were observed after treatment with the test material.
Any other information on results incl. tables
Table 1: Male Bodyweight Data (g)
Animal No. |
Body weight (g) Days |
Body Weight Gain (g) |
||||
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
|
9407 |
243 |
297 |
340 |
54 |
43 |
97 |
9408 |
254 |
307 |
351 |
53 |
44 |
97 |
9409 |
245 |
299 |
348 |
54 |
49 |
103 |
9410 |
243 |
291 |
339 |
48 |
48 |
96 |
9411 |
237 |
289 |
340 |
52 |
51 |
103 |
Mean |
244.4 |
296.6 |
343.6 |
52.2 |
47.0 |
99.2 |
Standard Deviation |
6.1 |
7.1 |
5.5 |
2.5 |
3.4 |
3.5 |
Table 2: Female Bodyweight Data (g)
Animal No. |
Body weight (g) Days |
Body Weight Gain (g) |
||||
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
|
9412 |
229 |
240 |
252 |
11 |
12 |
23 |
9413 |
237 |
247 |
280 |
10 |
33 |
43 |
9414 |
227 |
238 |
252 |
11 |
14 |
25 |
9415 |
237 |
263 |
263 |
26 |
0 |
26 |
9416 |
245 |
257 |
269 |
12 |
12 |
24 |
Mean |
235.0 |
249.0 |
263.2 |
14.0 |
14.2 |
28.2 |
Standard Deviation |
7.2 |
10.8 |
11.9 |
6.7 |
11.9 |
8.3 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, no signs of systemic or local toxic effects were observed during the 14 day observation period. The acute dermal LD50 of the test material was determined to be greater than 2000 mg/kg bw in both male and female rats.
- Executive summary:
The acute dermal toxicity of the test material was assessed in study performed under GLP conditions and in line with OECD 402, EU Method B.3, EPA OPPTS 870.1200 and JMAFF 2-1-2. A limit test was carried out at 2000 mg/kg bw in both sexes (5 rats/sex). The test material was applied as supplied, moistened with water, as a single dermal 24-hour exposure followed by a 14-day observation period. After the exposure period the residual test material was removed by washing the area with water. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).
Under the conditions of the study no mortality was observed at 2000 mg/kg bw. Bodyweights showed normal weight gain. No clinical signs of systemic or local toxic effects were observed during the 14 day observation period. Additionally there was no evidence of treatment related findings at necropsy. Accordingly the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg bw.
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