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EC number: 915-656-1 | 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:
- 30 January 2013 to 13 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with GLP and agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
- Remarks:
- Study conducted on read-across material
- Justification for type of information:
- A RAAF report will shortly be provided.
Cross-reference
- Reason / purpose for cross-reference:
- other: Read-across target
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- A RAAF report will shortly be provided.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of sodium hydrogen N-(1-oxooctadecyl) -L-glutamate and sodium hydrogen n-(1-oxohexadecyl) -L-glutamate
- IUPAC Name:
- Reaction mass of sodium hydrogen N-(1-oxooctadecyl) -L-glutamate and sodium hydrogen n-(1-oxohexadecyl) -L-glutamate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: White to pale yellow powder
- Storage conditions of test material: Room temperature (15-25 °C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CRL:(WI) (SPF)
- 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: 219 to 248 g
- Housing: Individually in type II polypropylene/polycarbonate cages
- Diet: ad libitum
- Water: municipal tap water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 to 70 % (relative)
- Air changes: 15 to 20 air changes per hour
- Photoperiod: 12 hour light/dark cycle (light from 06:00 to 18:00)
IN-LIFE DATES:
From: 24 January 2013
To: 13 February 2013
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back. Animals were shaved 24 hours prior to exposure
- % coverage: Approximately 10 %
- Type of wrap if used: Sterile gauze pads held in place by a patch with an adhesive hypoallergenic plaster and the entire trunk of the animal wrapped in a semi-occlusive plastic wrap.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water (at body temperature)
- Time after start of exposure: 24 hours
TEST MATERIAL
- For solids, paste formed: Yes; the test material was moistened with water to ensure good contact with the skin - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on the day of treatment at 1 and 5 hours after application and once each day 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. Body weights were recorded on Day 0 (prior to test material administration), and on days 7 and 14.
- Necropsy of survivors performed: Yes. All animals were anaesthetised with RELEASE 300 mg/mL inj. A.U.V and exsanguinated. 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 during the study.
- Clinical signs:
- other: No clinical signs, including local dermal signs, were observed after treatment with the test material or during the 14-day observation period.
- Gross pathology:
- There was no evidence of any macroscopic changes at necropsy.
Any other information on results incl. tables
Table 1: Bodyweight and Bodyweight Gain for Males
Animal No. |
Bodyweight (g) |
Bodyweight Gain (g) |
||||
Day 0 |
Day 7 |
Day 14 |
Days 0 to 7 |
Days 7 to 14 |
Days 0 to 14 |
|
9419 |
237 |
292 |
333 |
55 |
41 |
96 |
9420 |
248 |
292 |
334 |
44 |
42 |
86 |
9421 |
245 |
287 |
313 |
42 |
26 |
68 |
9422 |
234 |
281 |
329 |
47 |
48 |
95 |
9423 |
234 |
284 |
334 |
50 |
50 |
100 |
Mean |
239.6 |
287.2 |
328.6 |
47.6 |
41.4 |
89.0 |
Standard Deviation |
6.5 |
4.9 |
9.0 |
5.1 |
9.4 |
12.8 |
Table 2: Bodyweight and Bodyweight Gain for Females
Animal No. |
Bodyweight (g) |
Bodyweight Gain (g) |
||||
Day 0 |
Day 7 |
Day 14 |
Days 0 to 7 |
Days 7 to 14 |
Days 0 to 14 |
|
9424 |
230 |
252 |
262 |
22 |
10 |
32 |
9425 |
227 |
256 |
272 |
29 |
16 |
45 |
9426 |
243 |
260 |
273 |
17 |
13 |
30 |
9427 |
220 |
240 |
275 |
20 |
35 |
55 |
9428 |
219 |
232 |
251 |
13 |
19 |
32 |
Mean |
227.8 |
248.0 |
266.6 |
20.2 |
18.6 |
38.8 |
Standard Deviation |
9.7 |
11.7 |
10.1 |
6.0 |
9.8 |
10.8 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute dermal median lethal dose (LD50) was determined to be > 2000 mg/kg bw in male and female rats.
- Executive summary:
The acute dermal toxicity of the test material was determined in male and female CRL:(WI) rats in accordance with the standardised guideline OECD 402 under GLP conditions.
The study was performed as a limit test. 2000 mg/kg bw was applied to the shaved back of 5 animals of each sex (equating to around 10 % of the surface area of the skin) and covered with a semi-occlusive dressing. After 24 hours, the test site was washed with water and the animals were observed for any reactions over a fourteen day observation period. Bodyweights were recorded at days 0, 7 and 14. At the end of the study, all surviving animals were submitted for necropsy.
There was no mortality throughout the study and none of the animals demonstrated any clinical signs of toxicity. Bodyweights and bodyweight gains were not affected by test material administration. All animals were found to be normal at necropsy.
Under the conditions of this study, the acute dermal median lethal dose (LD50) was determined to be > 2000 mg/kg bw in male and female rats.
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