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EC number: 203-028-3 | CAS number: 102-40-9
- 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
- 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
An acute oral testing was performed on the test item according to the OECD 420.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System-Category 5).
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:
- Experimental start date: 27 September 2018 and Experimental completion date: 16 October 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- (RccHan™:WIST) strain
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ENVIGO RMS (UK) Limited, Oxon, UK.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks of age
- Weight at study initiation: the body weight variation did not exceed +/- 20% of the mean body weight of any previously treated animals.
- Fasting period before study and afetr dosing: One overnight fast immediately before dosing and for approximately 3 to 4 hours afetr dosing.
- Housing: Animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with softwood flake bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs 15 changes per hour light): 12 hours continuous light and 12 hours darkness.
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- For the purpose of the study the test item was freshly prepared, as required, as a solution in dimethyl sulfoxide. Dimethyl sulfoxide was used because the test item did not dissolve/suspend in distilled water or arachis oil BP.
The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 mg/kg at a concentration of 200 mg/mL (dose volume: 10 mL)
- No. of animals per sex per dose:
- A single female rat was dosed at 2000 mg/kg and in the absence of mortality at a dose level of 2000 mg/kg, an additional group of animals was treated at 2000 mg/kg.
- 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 on Day 0 (the day of dosing) and on Days 7 and 14 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained
- Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days.
- Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays. - Statistics:
- The following computerized system was used in the study:
Delta Controls – ORCAview (Version 3.4.0) - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal was killed for humane reasons, approximately 2¼ hours after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence.
- Clinical signs:
- Hunched posture was noted in four animals. Additional signs of systemic toxicity noted in two animals were decreased respiratory rate and or labored respiration and hypothermia. Incidents of ptosis, lethargy and red/brown staining around the snout were also noted in one animal. Incidents of systemic toxicity also noted in the animal that was humanely killed during the study were prostration, hypothermia, increased salivation, splayed gait, loss of righting reflex and diarrhea.
Surviving animals appeared normal 4 hours to 2 days after dosing. - Body weight:
- Surviving animals showed expected gains in body weight over the observation period.
- Gross pathology:
- Abnormalities noted at necropsy of the animal that was humanely killed were patchy pallor of the liver, pale kidneys and clear liquid present in the stomach. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System Category 5).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures. - Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Methods
Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as asolutionindimethyl sulfoxide, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. Oneanimal was killed for humane reasons, approximately2¼ hours after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence.
Clinical Observations. Hunched posture was noted in all four animals. Additional signs of systemic toxicity noted in two animals were decreased respiratory rate and or labored respiration and hypothermia with incidents of ptosis, lethargy, prostration, hypothermia, increased salivation, splayed gait, loss of righting reflex, diarrhea and red/brown staining around the snout. Surviving animals appeared normal 4 hours to 2 days after dosing.
Body Weight. Surviving animals showed expected gains in body weight.
Necropsy. Abnormalities noted at necropsy of the animal that was humanely killed were patchy pallor of the liver, pale kidneys and clear liquid present in the stomach. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Conclusion
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System-Category 5).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Reference
Individual Clinical Observations and Mortality Data
Dose Level (mg/kg) |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
1-0 |
H |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-0 |
0 |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-1 |
HPt |
HPt |
HPtRd |
HPtLRl |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 |
0 |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 |
WsSRlPr |
WsSRlPr |
PrHoRlSRr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0= No signs of systemic toxicity D = Diarrhea H = Hunched posture Ho = Hypothermia
L = Lethargy Pr = Prostration Pt = Ptosis Rd = Decreased respiratory rate
Rl = Labored respiration Rr = Loss of righting reflex S = Increased salivation Ws = Splayed gait
Ss = Red/brown staining around the snout
X* = One animal was killed for humane reasons, approximately 2¼ hours after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence
Individual Body Weights and Body Weight Changes
Dose Level (mg/kg) |
Animal Number and Sex |
Body Weight (g) at Day |
Body Weight (g) |
Body Weight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
|||
2000 |
1-0 Female |
155 |
186 |
201 |
|
31 |
15 |
2-0 Female |
156 |
170 |
190 |
|
14 |
20 |
|
2-1 Female |
158 |
172 |
187 |
|
14 |
15 |
|
2-2 Female |
151 |
170 |
183 |
|
19 |
13 |
|
2-3 Female |
162 |
- |
- |
156 |
- |
- |
- = Animal dead
Individual Necropsy Findings
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
2000 |
1-0 Female |
Killed Day 14 |
No abnormalities detected |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
|
2-1 Female |
Killed Day 14 |
No abnormalities detected |
|
2-2 Female |
Killed Day 14 |
No abnormalities detected |
|
2-3 Female |
Humanely killed Day 0 |
Liver: patchy pallor Kidneys: pale Stomach: clear liquid present |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Only this study is available and the study is Klimisch 1.
Additional information
Justification for classification or non-classification
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
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