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EC number: 944-892-8 | 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:
- 2009-11-17 to 2009-12-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2
- EC Number:
- 944-892-8
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- SPECIES: rat.
STRAIN: SPF (Specific pathogen free) Sprague-Dawley albino rats.
ORIGIN: Janvier supplier (53940 Le Genest-St-Isle, France).
AGE: about 7 weeks (when put in acclimatization).
NUMBER AND SEX: 6 nulliparous and non-pregnant females.
ACCLIMATIZATION: for a least 5 days prior to the experiment.
WEIGHT: on D-1, the day before the corresponding step of the experiment, animals were weighed. The mean weight was calculated and the acceptable limits were deduced, the externe individual weights of the animals could not deviate from the mean weight by more than +/- 10%.
IDENTIFICATION: the animals were identified individually per cage maximum, by marking with picric acid: the location of the marking, different for each animal, corresponded to a number. A caudal marking represented by a coloured circle with a marker pen enabled to identify the step.
HOUSING: the animals were housed at the rate of 3 per cage mximum, in 31 cm x 46 cm x 19 cm polypropylene cages with stainless steel lid. The bedding renewed regularly, was composed of wood shavings delivered dust-free and sterilized to y radiations. It was supplied by SICSA (94142 Alfortville, France). The cages were placed in limited-access premises, maintained in slight overpressure (a minimum of 10 mm of water), under air conditioned temperature (t = 22 +/- 2°C) and controlled relative humidity (RH = 50 +/- 20%) except during washing cycles and whose renewal in fresh filtered air (on absolut filter) was performed at the rate of about 10 cycles per hour. The artificial lighting enseured a sequence of 12 hours light, 12 hours dark.
FEEDING: the complete diet was supplied under pelleted form A04-10 delivered sterilized to y radiations by SAFE (89290 Augy, France).
DRINKING: the acidified tap water was distributed in polypropylene bottles with stainless steel teat. A sample of water was taken every 6 months at least and sent for physicochemical and bacteriological analysis to a specialized control organization.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test element was administered to a group of experimental animals, by oral route (gavage), at one of the defined doses (2000 mg/kg, 300 mg/kg, 50 mg/kg or 5 mg/kg) according to the available information on the test element.
According to the available information about the toxicity of the test element, the test started on 3 animals (Step 1) receiving a dose of 2000 mg/kg of body weight of test element.
After the 1st step, according to the methodology described in the annex 2d of the OECD guideline 423, the test was performed on 3 other animals receiving the test element at the dose level of 2000 mg/kg of body weight, under the same conditions as the animals from the step 1. - Doses:
- 2000 mg/kg, 300 mg/kg, 50 mg/kg or 5 mg/kg
Only the dose 2000 mg/kg was testing according to the available information about the toxicity of the test element and according the 1st step of the experimental chronology - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- The animals, fasted prior to the test element administration, were weighed again on D1 before administration. The volume per kg of body weight, defined according to the test element density as equal to 2.40 ml/kg, the volumes of test element were calculated for each rat.
The test element was administered in a single dose, orally, by gavage using a syringe with appropriate volume (1 ml), fitted with a suitable sized cannula (76 mm x 15/10th)
After administration, animals were fasted for 3 to 4 hours.
The animals were regularly weighed on D-1 the day before administration then on D1/T0 just before administration of the test element and on D4, D8 and D15 i.e. 3, 7 and 14 days after administration of the test element.
Animals were regularly observed the day of administration (immediately, during the 30 minutes following gavage, 1h, 2h, 3h and 4h after admninistration) then at least once a day for 14 days at least. - Statistics:
- the assessment criteria of the toxicity of the test element taken into account were:
- body weight change
- clinical and behavioural signs
- necropsy findings
- the mortality expressed in percentage of compound-related deaths
Results and discussion
- Preliminary study:
- According to the available information about the toxicity of the test element, the test started on 3 animals (Step 1) receiving a dose of 2000 mg/kg of body weight of test element.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during this test
- Clinical signs:
- other: A slight piloerection was observed just after treatment. Then, until the end of the experiment (D15), no symptom at all was observed anymore.
- Gross pathology:
- The post-mortem examination performed at the end of the observation period (D15) revealed no visible organic or tissue macroscopic lesion.
Any other information on results incl. tables
Body weight - Individual values
Dose = 2000 mg/kg
Animals N° | Weight (in g) | |||||
D1 | D4 | D8 | D15 | D15 -D1 | ||
Step 1 | 7475 | 230.7 | 262.2 | 270.5 | 300.2 | 69.5 |
7476 | 222.6 | 250.2 | 265.0 | 278.3 | 55.7 | |
7477 | 212.8 | 239.8 | 248.6 | 263.6 | 50.8 | |
Step 2 |
7478 |
234.9 |
260.9 |
279.0 |
300.9 |
66.0 |
7479 |
220.0 |
244.8 |
265.2 |
284.5 |
64.5 |
|
7480 |
229.9 |
254.3 |
278.4 |
282.1 |
52.2 |
|
Mean |
225.2 |
252.0 |
267.8 |
284.9 |
59.8 |
|
Standard deviation |
8.2 |
8.9 |
11.2 |
14.1 |
7.9 |
Clinical observations
Dose = 2000 mg/kg
Observation time | Comments | Observation time | Comments |
D1 (after treatment) | slight piloerection for all the animals | D6 | NTR |
D1 T30' | NTR | D7 | NTR |
D1 T1h | NTR | D8 | NTR |
D1 T2h | NTR | D9 | NTR |
D1 T3h | NTR | D10 | NTR |
D1 T4h | NTR | D11 | NTR |
D2 | NTR | D12 | NTR |
D3 | NTR | D13 | NTR |
D4 | NTR | D14 | NTR |
D5 | NTR | D15 | NTR |
NTR: nothing to report
Necropsy - Individual observations
Dose = 2000 mg/kg
Animals N° |
Death |
Comments |
||
Day |
Reason |
|||
Step 1 |
7475 |
D15 |
S |
NTR |
7476 |
D15 |
S |
NTR |
|
7477 |
D15 |
S |
NTR |
|
Step 2 |
7478 |
D15 |
S |
NTR |
7479 |
D15 |
S |
NTR |
|
7480 |
D15 |
S |
NTR |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- According to the results obtained and to the Globall harmonised System (GHS) for the classification and labelling of chemicals, the test element 5 a AVOCUTA(R) -CODE 8700492 was classified in the hazard category 5 with a LD50 higher than 2000 mg/kg in the rat.
- Executive summary:
Study: Tp 493 / 09 - 3039
Test element: 5 alpha AVOCUTA(R) - Code 8700492 - Cas: 934551 -20 -9 - Batch 0809402304
Result: The test element administered orraly in 6 female rats at the dose 2000 mg/kg resulted in:
- no mortality
- no significant symptomatology
- no change in the weight growth of the animals
- no visible organic or tissue alteration macroscopically
Conclusion: According to the results obtained and to the Globall harmonised System (GHS) for the classification and labelling of chemicals, the test element 5 alpha AVOCUTA(R) -CODE 8700492 was classified in the hazard category 5 with a LD50 higher than 2000 mg/kg in the rat.
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