Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 210-047-0 | CAS number: 603-52-1
Endpoint summary
Administrative data
Description of key information
Key study: OECD 423. GLP study. 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.
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:
- November 15, 2016 - November 30, 2016
- 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
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage 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: Step 1: 206 ± 6.1 g; Step 2 and 3: 236.8 ± 22.6 g
- Fasting period before study: overnight
- Housing: Rats were housed by group of three 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: foodstuff (ENVIGO - 2016) ad libitum
- Water: 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: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19ºC - 25ºC
- Humidity (%): 30% - 70%
- Air changes (per hr): Ten changes per hour
- Photoperiod (hrs dark / hrs light): Twelve hours light (07.00 to 19.00) / twelve hours darkness.
IN-LIFE DATES: From: November 15, 2016 To: November 30, 2016 - 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: it 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: Whitout preliminary information. The selected starting dose is 2000 mg/kg body weight. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Remarks:
- Study No. TAO423-2016-006 (see "Other information on results").Study No. TAO423-2016-006 (see "Other information on results").
- 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 administration and daily during 14 days. Weighing: on Day 0 (just before administering the test item) then on Day 2, Day 7, and Day 14.
- 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:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- ca. 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: A decrease of spontaneous activity (4/6), muscle tones (3/6), righting reflex (3/6) and Preyer's reflex (2/6) associated with an increase of salivation (2/6) was noted during the first hours of the test. The animals recovered a normal activity at 24 hours
- 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. 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.
- 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. An absence of body weight gain was noted on day 2 versus day 0. Then the body weight evolution of the animals remained normal during the study. A decrease of spontaneous activity (4/6), muscle tones (3/6), righting reflex (3/6) and Preyer's reflex (2/6) associated with an increase of salivation (2/6) was noted during the first hours of the test. The animals recovered a normal activity at 24 hours 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: results in Tables 1 to 5.
Body weight evolution: normal during the test (Table 6).
Macroscopical examinations: Nothing to report.
Table 1. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
FEMALES |
||||
T0 + 30 minutes |
Rf 0715 |
Rf 0716 |
Rf 0717 |
Rf 0727 |
Rf 0728 |
Rf 0729 |
Spontaneous activity |
N |
N |
N |
N |
N |
D |
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 |
A |
N |
A |
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)
A: Increased
D: Decreased
Table 2. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
FEMALES |
||||
T0 + 1 hour |
Rf 0715 |
Rf 0716 |
Rf 0717 |
Rf 0727 |
Rf 0728 |
Rf 0729 |
Spontaneous activity |
N |
N |
N |
N |
N |
D |
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 |
A |
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)
A: Increased
D: Decreased
Table 3. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
FEMALES |
||||
T0 + 3 hours |
Rf 0715 |
Rf 0716 |
Rf 0717 |
Rf 0727 |
Rf 0728 |
Rf 0729 |
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. Observation data sheet.
OBSERVATIONS: |
FEMALES |
FEMALES |
||||
T0 + 4 hours |
Rf 0715 |
Rf 0716 |
Rf 0717 |
Rf 0727 |
Rf 0728 |
Rf 0729 |
Spontaneous activity |
D |
D |
D |
N |
N |
N |
Preyer’s réflex (noise) |
N |
D |
D |
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 |
D |
D |
D |
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 |
D |
D |
D |
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)
D: Decreased/ Limited (Righting reflex)
Table 5. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
FEMALES |
||||
D1 to D14 |
Rf 0715 |
Rf 0716 |
Rf 0717 |
Rf 0727 |
Rf 0728 |
Rf 0729 |
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 6. Body weight and weight gain in grams.
FEMALES |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
||||
Rf 0715 |
201 |
207 |
6 |
240 |
39 |
269 |
68 |
||||
Rf0716 |
207 |
222 |
15 |
251 |
44 |
271 |
64 |
||||
Rf 0717 |
208 |
169 |
-39 |
193 |
-15 |
244 |
36 |
||||
Rf 0727 |
209 |
218 |
9 |
249 |
40 |
271 |
62 |
||||
Rf 0728 |
214 |
229 |
15 |
253 |
39 |
276 |
62 |
||||
Rf 0729 |
197 |
208 |
11 |
235 |
38 |
259 |
62 |
||||
MEAN |
206.0 |
208.8 |
2.8 |
236.8 |
30.8 |
265.0 |
59.0 |
||||
Standard deviation |
6.1 |
21.2 |
20.8 |
22.6 |
22.6 |
11.7 |
11.5 |
||||
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
- Quality of whole database:
- Klimish score 1. GLP study.
Additional information
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.An absence of body weight gain was noted on day 2 versus day 0. Then the body weight evolution of the animals remained normal during the study.A decrease of spontaneous activity (4/6), muscle tones (3/6), righting reflex (3/6) and Preyer's reflex (2/6) associated with an increase of salivation (2/6) was noted during the first hours of the test. The animals recovered a normal activity at 24 hours 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
