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EC number: 947-853-3 | 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
Endpoint summary
Administrative data
Description of key information
- study conducted according to OECD guideline 404, GLP, 3 Sprague Dawley rats were administered a single dose of 5000 mg/kg bw of hydrogentated tallow/nortallow based IQAC by oral gavage, no mortality or treatment-related clinical signs occured, LD50 > 5000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-07-26 to 2017-10-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 185-197 g
- Fasting period before study: 16 h before administration
- Housing: individually or pair in MAKROLON cages (type III plus). Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages.
- Diet (e.g. ad libitum): ad libitum until 16 h before the first administration, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 12 to 18
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- other: Sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): The test item was suspended in sesame oil to a concentration of 500 mg/mL, considering the correction factor of 1.32.
CLASS METHOD (if applicable) Acute toxic class
- Rationale for the selection of the starting dose: 5000 mg/kg bw as recommended by the guideline. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All animals were observed for a period of 14 days. During the follow-up period of two weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working
day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Observations on prematurely deceased animals were made at least once daily to minimize loss of animals during the study. The time of death would have been recorded as precisely as possible. At the end of the experiments, all animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. - Statistics:
- No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD 50 value).
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: Under the present test conditions, a single oral administration of 5000 mg test item/kg b.w. revealed slightly reduced motility, ataxia, reduced muscle tone and dyspnoea 15 minutes after administration until test days 3 or 4 and, in
- Gross pathology:
- No pathological changes were observed at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the present study 3 female Sprague Dawley rats were administered 5000 mg/kg bw of the test item by gavage and observed for 14 days. Clinical signs were only detected in one of the animals and were reversible. No premature death occurred and there were no findings at necropsy of the animals, thus, the substance does not need to be classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
- Executive summary:
In an acute oral toxicity study according to OECD guideline 404, three female Sprague Dawley rats, weighing 185- 197g and aged approximately 8 weeks old were given a single oral dose of IS-2017-761 (100 % a.i.) in sesame oilat a dose of 5000 mg/kg bw and observed for 14 days.
Oral LD50Females ≥ 5000 mg/kg bw
Limit test, no mortality was observed
IS-2017-761 is of LOW Toxicity based on the LD50in female Sprague Dawley rats. There were no treatment related clinical signs, necropsy findings or changes in body weight, thus the substance does not need to be classififed according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
Reference
Tabel 1: Summarized results
5000 mg test irem/kg b.w., p.o.
Symptoms/Criteria |
(n = 1) femalefirst step |
(n = 2) femalessecond step |
Clinical signs |
||
reduced motility |
+15'-TD 4 (1) |
|
ataxia
|
+15'-TD 4(1) |
|
reduced muscle tone
|
+15'-TD 3(1) |
|
dyspnoea
|
+15'-TD 3(1) |
|
forepaw bloody |
+3h-TD 3(1) |
|
forepaw with scab |
+TD 4-TD 7(1) |
|
Mortality |
||
within 6h |
0 |
|
within 24 h |
0 |
|
within 7 days |
0 |
|
within 14 days |
0 |
|
Mean body weight (in g) |
||
start |
185 |
193.5 |
after 7 days |
192 (+3.8) |
220.5 (+14.0) |
after 14 days |
223 (+ 20.5 |
229.5 (+18.6) |
inhibition of body weight gain |
none |
none |
necropsy findings |
none |
none |
in brackets: number of animals affected
': minutes
h: hours
TD: test
day
b.w.: body
weight
p.o.: per
oral
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The study was conducted according to OECD 404, thus the study is considered to be of high quality.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an acute oral toxicity study according to OECD guideline 404, three female Sprague Dawley rats, weighing 185- 197g and aged approximately 8 weeks old were given a single oral dose of hydrogentaed tallow/nortallow based IQAC (100 % a.i.) in sesame oil at a dose of 5000 mg/kg bw and observed for 14 days.
Oral LD50Females ≥ 5000 mg/kg bw
Limit test, no mortality was observed
hydrogentaed tallow/nortallow based IQAC is of LOW Toxicity based on the LD50in female Sprague Dawley rats.
Justification for classification or non-classification
There were no treatment related clinical signs, necropsy findings or changes in body weight in an acute oral toxicity test, thus the substance does not need to be classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with respect to acute oral toxicity.
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