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Diss Factsheets
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EC number: 918-984-3 | 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-01-14 to 2004-01-29
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction product of apple aminoacids and lauroyl chloride
- EC Number:
- 918-984-3
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction product of apple aminoacids and lauroyl chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
- Reference substance name:
- 2-methylpentane-2,4-diol
- EC Number:
- 203-489-0
- EC Name:
- 2-methylpentane-2,4-diol
- Cas Number:
- 107-41-5
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 2-methylpentane-2,4-diol
- Reference substance name:
- Tetrasodium ethylenediaminetetraacetate
- EC Number:
- 200-573-9
- EC Name:
- Tetrasodium ethylenediaminetetraacetate
- Cas Number:
- 64-02-8
- Molecular formula:
- C10H16N2O8.4Na
Constituent 1
Constituent 2
Constituent 3
additive 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 12 Sprague Dawle y rats (SPF Caw) originating from Elevage Janvier (53940 Le Genest-St-Isle –France), were used after a 5 to 6-day acclimatisation
period. At the beginning of the study, the animals weighted between 184g and 209g (males) and between 165g and 178g (females).
Environmental parameters for the treated group :
- temperature : between 22°C and 24°C
- relative humidity : between 30% and 51%
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The animals of Group 2, received an effective dose of 2000 mg/kg body weight of product, administered by force-feeding under a volume of 1.84 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
- Doses:
- 2000 mg/kg body weight of product
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- Details on study design:
- The study was carried out between 14 January 2004 and 29 January 2004, in PHYCHER Bio développement, according to the experimental protocol Ref. TAO423-version December 2000, established according to the O.E.C.D. guideline N° 423 dated 03.22.1996 concerning acute oral toxicity and the test method B.1ter of the Directive N° 96/54/EC dated 07.30.1996.
The animal control group was performed between 13 January 2004 and 28 January 2004 according to the same experimental conditions, with administration of 2000 mg/kg body weight of the control product (Distilled water), under a volume of 2 mL/kg body weight. - Statistics:
- no data
Results and discussion
- Preliminary study:
- no preliminary study
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 related to the administration of the test product were observed.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the product Proteol APL is higher than 2000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C.
Directives 67/548, 2001/59 and 99/45, the product Proteol APL must not be classified - Executive summary:
The product Proteol APL was administred to a group of 6 Sprague Dawley rats (3 males and 3 females) at the single dose of 2000 mg/kg body weight according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline N° 423 dated March 22nd, 1996 and the test method B.1ter of the Directive N°96/54/EC dated July 30th, 1996. No mortality occurred during the study. No clinical signs related to the administration of the test product were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the product Proteol APL is higher than 2000 mg/kg body weight by oral route in the rat. According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the product Proteol APL must not be classified
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