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EC number: 238-122-3 | CAS number: 14246-53-8
- 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:
- july-03-2007 to August-23-07
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- N-(1-oxooctyl)glycine
- EC Number:
- 238-122-3
- EC Name:
- N-(1-oxooctyl)glycine
- Cas Number:
- 14246-53-8
- Molecular formula:
- C10H19NO3
- IUPAC Name:
- N-(1-oxooctyl)glycine
- Reference substance name:
- LCA07012
- IUPAC Name:
- LCA07012
- Details on test material:
- - Name of test material (as cited in study report): LCA07012
- Molecular formula (if other than submission substance):
- Substance type:substance well defined
- Physical state: solid, powder
- Lot/batch No.: 0716300006
- Expiration date of the lot/batch: 11 June 2010 (re-test)
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Twenty Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle
– France), were used after an acclimatisation period of at least five days. At the beginning of the study,
the animals of the treated group weighed between 224 g and 256 g (males) and between 203 g and
217 g (females) and were 6-8 weeks old.
Group 1 (control): 5 male rats Rm9371 to Rm9375
and 5 female rats Rf9376 to Rf9380
Group 2 (treated): 5 male rats Rm9641 to Rm9645
and 5 female rats Rf9646 to Rf9650
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely except
during treatment period for the food.
Microbiological and chemical analyses of the water were carried out once every six months by the
Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).
During the treatment, the animals were kept in individual cage. At D3, the animals were put into their
cage by 2 or 3. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel
mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage
was installed in conventional air conditioned animal husbandry; the environmental conditions were:
- temperature : between 20 °C and 25 °C
- relative humidity : between 43 % and 62 %
- lighting time: 12 hours daily
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- paraffin oil
- Details on dermal exposure:
- TEST SITE
-Animals from Group 2 received by topical application (10% of area body), under porous gauze dressing, an effective dose
of 2000 mg/kg body weight of LCA07012, diluted in liquid paraffin under a volume of 10 mL/kg
body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed.
Animals from Group 1 received in the same experimental conditions the control item (distilled water)
under a volume of 2 mL/kg body weight.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):2000mg/kg
-Concentration (if solution): 10ml/kg
- For solids, paste formed: yes
- Duration of exposure:
- 24hours
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5 animal/sex/dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:the animals wer weighed on day D0(just before administering the test item) then on D2, D7 and D14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LDLo
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- other: NOEL acute dermal systemic
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- other: NOEC acute dermal local
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- none
- Clinical signs:
- other: Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.
- Other findings:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related
changes.
Any other information on results incl. tables
No mortality occurred during the study. The clinical observations are given in the observations data sheet, tables 1 to 4 and those of body weight evolution in tables 5 and 6, hereafter. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The results of the macroscopical examinations are given in the necropsy data sheet, tables 7 to 10, hereafter. 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:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The LD50 of the test item is higher than 2000 mg/kg body weight by dermal 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 test item
need not to be classified. No symbol and risk phrase are required. - Executive summary:
The test item was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline. n° 402 dated February 24th, 1987 and the test method B.3 of the directive. n° 92/69/EEC. No mortality occurred during the study. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item 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 test item is higher than 2000 mg/kg body weight by dermal 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 test item need not to be classified. No symbol and risk phrase are required
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