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EC number: 223-841-7 | CAS number: 4093-34-9
- 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
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- 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
Acute oral toxicity:
Key study: OECD 423 and EU method B.1 tris. Klimish score = 1. GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.
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:
- March 14, 2017 - March 29, 2017
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: yes - Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- SPF Caw
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: JANVIER LABS (53940 Le Genest St Isle - France)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks old
- Weight at study initiation: 205.8 ± 10.1
- Fasting period before study: overnight
- Housing: 3 females 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.
- Diet (e.g. ad libitum): Foodstuff (ENVIGO -2016) ad libitum
- Water (e.g. ad libitum): Tap-water from public distribution system ad libitum. Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas- Eurofins (France)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19ºC - 25ºC
- Humidity (%): 30% - 70%. A relative humidity lower than 30% was registered from 14 to 19 March 2017 and from 22 to 29 March 2017. The minimum value measured was 19%. The deviation is considered as without impact on the conclusion of the study.
- Air changes (per hr): At least 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours contimuous light (07.00 to 19.00) and twelve hours darkness.
IN-LIFE DATES: From: To: 14 March 2017 - 29 March 2017 - Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2 g/ 10 mL
- Amount of vehicle (if gavage): 10 mL/Kg
- Justification for choice of vehicle: DMSO produced the most suitable formulation at the requested concentration.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/Kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Without preliminary information. The selected starting dose is 2000 mg/kg body weight. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Remarks:
- Control group refer to a control study performed from 28 February 2017 to 14 March 2017
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systemic observations at 30 min, 1h, 3h, 4h, 24h, 48h after adminitrationand daily during 14 days. Weighing= D0 (just before administering the test item) then on D2, D7, and D14.
- Necropsy of survivors performed: yes. At termination, macroscopic observation was observed. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Parameters examined: Oesophagus, Stomach, Duodenum, Jejunum, Ileon, Caecum, Colon, Rectum, Spleen, Liver, Thymus, Trachea, Lungs, Heart, Kidneys, Urinary Bladder, Ovaries, Uterus, Treatment Area, Adrenals and Pancreas.
- Other examinations performed:
Clinical signs: Spontaneous activity, Preyer's reflex (noise), Respiratory rate, Convulsions, Tremors, Body temperature, Muscle tone, Palpebral opening, Pupil appearance, Salivation, Lachrymation, Righting reflex, Back hair appearance, Mortality. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- Myosis was noted at 30 minutes post dose in three treated animals (3/6). The animals recovered a normal activity at 1 hour post dose. No others signs of systemic toxicity were noted.
- Body weight:
- The body weight evolution of the animals remained normal during the study.
- Gross pathology:
- The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.
- Executive summary:
The acute oral toxicity of the test item has been tested in accordance with OECD 423 and EU method B.1 tris, following GLP. The test item was administered to a group of 6 female Sprague-Dawley rats at the dose of 2000 mg/kg body weight by oral gavage. No mortality occurred during the study and the body weight evolution of the animals remained normal during the study. Myosis was noted at 30 minutes post dose in three treated animals (3/6). The animals recovered a normal activity at 1 hour post dose. No others signs of systemic toxicity were noted. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat.
Reference
Clinical observations: observation data sheets (Tables 1 to 4).
Body weight evolution: Table 5.
Macroscopical examinations: necropsy data sheets (Tables 5 and 6).
Table 1. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
FEMALES |
||||
T0 + 30 minutes |
Rf 1251 |
Rf 1252 |
Rf 1253 |
Rf 1270 |
Rf 1271 |
Rf 1272 |
Spontaneous activity |
N |
N |
N |
N |
N |
N |
Preyer’s réflex (noise) |
N |
N |
N |
N |
N |
N |
Repiratory rate |
N |
N |
N |
N |
N |
N |
convulsions |
N |
N |
N |
N |
N |
N |
tremors |
N |
N |
N |
N |
N |
N |
Body temperature |
N |
N |
N |
N |
N |
N |
Muscle tone |
N |
N |
N |
N |
N |
N |
Palpebral opening |
N |
N |
N |
N |
N |
N |
Pupil appearance |
Ms |
Ms |
Ms |
N |
N |
N |
Salivation |
N |
N |
N |
N |
N |
N |
Lachrymation |
N |
N |
N |
N |
N |
N |
Ringhting reflex |
N |
N |
N |
N |
N |
N |
Back hair appearance |
N |
N |
N |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
0 |
0 |
0 |
Remarks |
None |
None |
|
|
N: Normal / None (Convulsions, Tremors)
Md: Ms (Myosis)
Table 2. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
FEMALES |
||||
T0 + 1 hour T0 + 3 hours T0 + 4 hours |
Rf 1251 |
Rf 1252 |
Rf 1253 |
Rf 1270 |
Rf 1271 |
Rf 1272 |
Spontaneous activity |
N |
N |
N |
N |
N |
N |
Preyer’s réflex (noise) |
N |
N |
N |
N |
N |
N |
Repiratory rate |
N |
N |
N |
N |
N |
N |
convulsions |
N |
N |
N |
N |
N |
N |
tremors |
N |
N |
N |
N |
N |
N |
Body temperature |
N |
N |
N |
N |
N |
N |
Muscle tone |
N |
N |
N |
N |
N |
N |
Palpebral opening |
N |
N |
N |
N |
N |
N |
Pupil appearance |
Ms |
Ms |
Ms |
N |
N |
N |
Salivation |
N |
N |
N |
N |
N |
N |
Lachrymation |
N |
N |
N |
N |
N |
N |
Ringhting reflex |
N |
N |
N |
N |
N |
N |
Back hair appearance |
N |
N |
N |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
0 |
0 |
0 |
Remarks |
None |
None |
|
|
N: Normal / None (Convulsions, Tremors)
Md: Ms (Myosis)
Table 3. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
FEMALES |
||||
D1 to D14 |
Rf 1251 |
Rf 1252 |
Rf 1253 |
Rf 1270 |
Rf 1271 |
Rf 1272 |
Spontaneous activity |
N |
N |
N |
N |
N |
N |
Preyer’s réflex (noise) |
N |
N |
N |
N |
N |
N |
Repiratory rate |
N |
N |
N |
N |
N |
N |
convulsions |
N |
N |
N |
N |
N |
N |
tremors |
N |
N |
N |
N |
N |
N |
Body temperature |
N |
N |
N |
N |
N |
N |
Muscle tone |
N |
N |
N |
N |
N |
N |
Palpebral opening |
N |
N |
N |
N |
N |
N |
Pupil appearance |
N |
N |
N |
N |
N |
N |
Salivation |
N |
N |
N |
N |
N |
N |
Lachrymation |
N |
N |
N |
N |
N |
N |
Ringhting reflex |
N |
N |
N |
N |
N |
N |
Back hair appearance |
N |
N |
N |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
0 |
0 |
0 |
Remarks |
None |
None |
|
|
N: Normal / None (Convulsions, Tremors)
Table 4. Test item at 2000 mg/kg bw. Body weight and weight gain in grams.
FEMALES |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
||||
Rf 1251 |
214 |
226 |
12 |
254 |
40 |
281 |
67 |
||||
Rf1252 |
195 |
208 |
13 |
232 |
37 |
280 |
85 |
||||
Rf 1253 |
204 |
212 |
8 |
238 |
34 |
274 |
70 |
||||
Rf 1270 |
220 |
230 |
10 |
256 |
36 |
278 |
58 |
||||
Rf 1271 |
207 |
227 |
20 |
250 |
43 |
275 |
68 |
||||
Rf 1272 |
195 |
206 |
11 |
234 |
39 |
258 |
63 |
||||
MEAN |
205.8 |
218.2 |
12.3 |
244.0 |
38.2 |
274.3 |
68.5 |
||||
Standard deviation |
10.1 |
10.7 |
4.1 |
10.6 |
3.2 |
8.5 |
9.1 |
||||
Table 5. Necropsy data sheet of rats Rf1251 to Rf1253 (28 March 2017)
Found dead:
|
Euthanasia: X
|
At term:
|
GENERAL APPEARANCE BEFORE AUTOPSY: Normal
|
||
|
Observed Organs
|
Observations
|
* OESOPHAGUS |
X |
N.t.R. |
* STOMACH |
X |
N.t.R. |
* DUODENUM |
X |
N.t.R. |
* JEJUNUM |
X |
N.t.R. |
* ILEON |
X |
N.t.R. |
* CAECUM |
X |
N.t.R. |
* COLON |
X |
N.t.R. |
* RECTUM |
X |
N.t.R. |
* SPLEEN |
X |
N.t.R. |
* LIVER |
X |
N.t.R. |
* THYMUS |
X |
N.t.R. |
* TRACHEA |
X |
N.t.R. |
* LUNGS |
X |
N.t.R. |
* HEART |
X |
N.t.R. |
* KIDNEYS |
X |
N.t.R. |
* URINARY BLADDER |
X |
N.t.R. |
* OVARIES |
X |
N.t.R. |
* UTERUS |
X |
N.t.R. |
* TREATMENT AREA |
- |
- |
* ADRENALS |
X |
N.t.R. |
* PANCREAS |
X |
N.t.R. |
PARTICULARS. None
|
N.t.R.: Nothing to report
Table 6. Necropsy data sheet of rats Rf1270 to Rf1272 (29 March 2017)
Found dead:
|
Euthanasia: X
|
At term:
|
GENERAL APPEARANCE BEFORE AUTOPSY: Normal
|
||
|
Observed Organs
|
Observations
|
* OESOPHAGUS |
X |
N.t.R. |
* STOMACH |
X |
N.t.R. |
* DUODENUM |
X |
N.t.R. |
* JEJUNUM |
X |
N.t.R. |
* ILEON |
X |
N.t.R. |
* CAECUM |
X |
N.t.R. |
* COLON |
X |
N.t.R. |
* RECTUM |
X |
N.t.R. |
* SPLEEN |
X |
N.t.R. |
* LIVER |
X |
N.t.R. |
* THYMUS |
X |
N.t.R. |
* TRACHEA |
X |
N.t.R. |
* LUNGS |
X |
N.t.R. |
* HEART |
X |
N.t.R. |
* KIDNEYS |
X |
N.t.R. |
* URINARY BLADDER |
X |
N.t.R. |
* OVARIES |
X |
N.t.R. |
* UTERUS |
X |
N.t.R. |
* TREATMENT AREA |
- |
- |
* ADRENALS |
X |
N.t.R. |
* PANCREAS |
X |
N.t.R. |
PARTICULARS: None
|
N.t.R.: Nothing to report
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
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
Acute oral toxicity:
Key study: The acute oral toxicity of the test item has been tested in accordance with OECD 423 and EU method B.1 tris, following GLP. The test item was administered to a group of 6 female Sprague-Dawley rats at the dose of 2000 mg/kg body weight by oral gavage. No mortality occurred during the study and the body weight evolution of the animals remained normal during the study.Myosis was noted at 30 minutes post dose in three treated animals (3/6). The animals recovered a normal activity at 1 hour post dose. No others signs of systemic toxicity were noted.The macroscopic examination of the animals at the end of the study did not reveal treatment related changes. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat.
Justification for classification or non-classification
Based on the available information (LD50 > 2000 mg/kg bw), the substance is not classified for acute toxicity according to CLP Regulation (EC) no. 1272/2008
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