Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 210-694-9 | CAS number: 621-59-0
- 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
Acute oral toxicity: Key study: OECD 423 and EU method B.1
tris. 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
- 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
- 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: Six Sprague Dawley rats (SPF Caw) supplied by Elevage JANVIER LABS (53940 Le Genest St Isle – France)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: At the beginning of the study, the animals were 8-week old, with a mean body weight of 195 g (SD: 2.9).
- Fasting period before study: yes
- Housing: Healthy female 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 (e.g. ad libitum): standard laboratory foodstuff (ENVIGO 2016) ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25ºC
- Humidity (%): 30-70%
- Air changes (per hr): at least 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark.
IN-LIFE DATES: From: 12/12/2017 - To: 27/12/2017 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- CLASS METHOD
- Rationale for the selection of the starting dose: As no information regarding the acute toxicity of the test item was available suggesting toxicity of the test item and in accordance with the principles of animal welfare, the first tested dose was 2000 mg/ kg b.w. - Doses:
- Step 1: 2000 mg/kg bw.
Step 2: 2000 mg/kg bw. - No. of animals per sex per dose:
- 3 female rats were used in step 1 (Rf2182 to Rf2184) and 3 female rats in step 2 (Rf2185 to Rf2187)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 30 min, 1h, 3h, 4h, 24h, 48h after administration of the test item and continued daily during 14 days. Weight was determined on day 0 (directly before administration), 2, 7 and 14 before euthanasia.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross examinations. - 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:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: A decrease in spontaneous activity (6/6), muscle tones (3/6), righting reflex (3/6), Preyer’s reflex (3/6) associated with hypothermia (3/6), an increase of salivation (3/6), piloerection (1/6), noisy breathing (2/6) and nasal secretions (1/6) were noted
- 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
- Remarks:
- EU criteria
- Conclusions:
- The oral LD50 of the test item in female rats was greater thatn 2000 mg/kg bw. The LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg bw.
- Executive summary:
The potential acute toxicity of the test item was studied on female Sprague-Dawley rats, according to OECD TG 423, under GLP conditions. Since no data indicating acute toxicity was available, a first step was performed by administering a single dose of 2000 mg/kg bw test item to three animals by gavage. As no mortality was observed, a second step was performed by dosing three additional animals with the same dose. No mortality occurred during the study. A decrease in spontaneous activity (6/6), muscle tones (3/6), righting reflex (3/6), Preyer’s reflex (3/6)associated with hypothermia (3/6), an increase of salivation (3/6), piloerection (1/6), noisy breathing (2/6) and nasal secretions (1/6) were noted during the first hours of the test. The animals recovered a normal activity between days 1 and 5. An absence of body weight gain was noted on day 2 versus day 0. Then, the body weight evolution of the animals was normal. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes. Based on the results, the oral LD50 was found to be > 2000 mg/kg bw. In accordance with the OECD TG 423, 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
Table 1. Body weights and weight gain of the animals (grams)
FEMALES |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
Rf 2182 Rf 2183 Rf 2184 |
201 193 195 |
220 202 208 |
19 9 13 |
231 232 228 |
30 39 33 |
246 245 250 |
45 52 55 |
Rf 2185 Rf 2186 Rf 2187 |
194 196 194 |
195 188 161 |
1 -8 -33 |
218 221 222 |
24 25 28 |
240 249 245 |
46 53 51 |
MEAN Standard deviation |
195.5 2.9
|
195.7 20.2
|
0.2 18.8.
|
225.3 5.8
|
29.8 5.6
|
245.8 3.5
|
50.3 4.0
|
Table 2. Clinical signs, overall list.
Dose (mg/kg bw) |
Time |
Mortality |
Step 1. Animal Rf. |
Step 2. Animal Rf. |
||||
2182 |
2183 |
2184 |
2185 |
2186 |
2187 |
|||
2000 |
30 min |
0 |
N |
N |
N |
SIGNS |
SIGNS |
SIGNS |
1 h |
0 |
SIGNS |
SIGNS |
SIGNS |
SIGNS |
SIGNS |
SIGNS |
|
3 h |
0 |
SIGNS |
SIGNS |
SIGNS |
N |
N |
N |
|
4 h |
0 |
SIGNS |
SIGNS |
SIGNS |
N |
N |
N |
|
D1 |
0 |
N |
N |
N |
N |
N |
SIGNS |
|
D2-D4 |
0 |
N |
N |
N |
N |
N |
N |
|
D5-D14 |
0 |
N |
N |
N |
N |
N |
N |
|
|
||||||||
Remarks |
30min |
Rf2186, 2187: noisy breathing Rf2186: nasal secretions, little regurgitation. |
||||||
1h - 4h, D1-D4 |
Rf2186, 2187: noisy breathing |
|||||||
D5-D14 |
none |
Table 3. Necropsy findings, overall list.
Observations |
Step 1 Animals Rf2182-2184 |
Step 2 Animals Rf2185-2187 |
General Appearance |
Normal |
Normal |
Oesophagus |
NtR |
NtR |
Stomach |
NtR |
NtR |
Duodenum |
NtR |
NtR |
Jejunum |
NtR |
NtR |
Ileon |
NtR |
NtR |
Caecum |
NtR |
NtR |
Colon |
NtR |
NtR |
Rectum |
NtR |
NtR |
Spleen |
NtR |
NtR |
Liver |
NtR |
NtR |
Thymus |
NtR |
NtR |
Trachea |
NtR |
NtR |
Lungs |
NtR |
NtR |
Heart |
NtR |
NtR |
Kidneys |
NtR |
NtR |
Urinary Bladder |
NtR |
NtR |
Overies |
NtR |
NtR |
Uterus |
NtR |
NtR |
Adrenals |
NtR |
NtR |
Pancreas |
NtR |
NtR |
Particulars |
None |
None |
*NtR: Nothing to report.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Klimish score 1.
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 potential acute toxicity of the test item was studied on female Sprague-Dawley rats, according to OECD TG 423, under GLP conditions. 6 animals were administered a single dose of 2000 mg/kg bw test item, as supplied, by gavage. A decrease in spontaneous activity (6/6), muscle tones (3/6), righting reflex (3/6), Preyer’s reflex (3/6) associated with hypothermia (3/6), an increase of salivation (3/6), piloerection (1/6), noisy breathing (2/6) and nasal secretions (1/6) were noted during the first hours of the test. The animals recovered a normal activity between days 1 and 5. An absence of body weight gain was noted on day 2 versus day 0. Then, the body weight evolution of the animals was normal. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes. Based on the results, the oral LD50 was found to be > 2000 mg/kg bw. In accordance with the OECD TG 423, 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 (oral LD50 5000 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.