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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-886-1 | CAS number: 128-44-9
- 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
Acute toxicity:Oral
The acute oral median lethal dose (LD50) of test chemical in male/female sprague-dawley rat was determined to be 8440-9710 mg/kg of body weight. LD50 value indicates that the test chemical does not exhibits acute toxicity by the oral route.
Acute Toxicity:Inhalation
The particle size distribution of the test substance was found to vary in the size of 53-500 µm, so the potential for the generation of inhalable forms is low.Moreover the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore acute toxicity by inhalation route was considered to be waived.
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
- Justification for type of information:
- Experimental study performed using standard test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity study of test chemical was performed on Rats(Male/female)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Test animals :Spraque-Dawley rats (male/female), SPF breed : WIGA, Sulzfeld, FR G
Body weight : 77/13 0
Mean weight for
- male animals : 298 g
- female animals : 215 g
Diet : The animals were offered Herilan MRH-Kraftfutter, supplied by H . EGGERSMANN, Rinteln/Weser, FRG, and water ad libitum . Diet withdrawn 16 hours before beginning of study .
Form of application : The product was administered once by gavage as a 50% solution in aqua dest . in doses of 5620, 6810, 8250 and 10000 mg/kg . - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No details available
- Route of administration:
- oral: drinking water
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- the product was administered once by gavage as a 50% solution in aqua dest . in doses of 5620, 6810, 8250 and 10000 mg/kg .
- Doses:
- 5620 mg/kg
6810 mg/kg
8250 mg/kg
and 10000 mg/kg - No. of animals per sex per dose:
- 10 males
10 female - Control animals:
- not specified
- Details on study design:
- Not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 8 980 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no other details available
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 9 140 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no other details available
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 8 820 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no other details available
- Mortality:
- 50% death was observed in male and female rats
- Clinical signs:
- other: Not specified
- Gross pathology:
- Not specified
- Other findings:
- Not specified
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute oral median lethal dose (LD50) of test chemical in male/female sprague-dawley rat was determined to be 8440-9710 mg/kg of body weight. LD50 value indicates that the test chemical does not exhibits acute toxicity by the oral route.
- Executive summary:
The acute oral toxicity of test chemical was performed in Sprague-Dawley rats . For this purpose, the product was administered once by gavage as a 50% solution in aqua dest . in doses of 5620, 6810, 8250 and 10000 mg/kg .
The median lethal dose (LD 50) after 14 days was observed to be 8980 (8440 - 9710) mg/kg in male and female rats.In male animals LD50 value was observed to be 9140 (8350 - 10510) mg/kg whereas in female animals ,8820 (7960 - 10090) mg/kg.
From the above study it is concluded that test chemical does not exhibits acute toxicity by the oral route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 8 980 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from study report
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Quality of whole database:
- Waiver
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data from various test chemicals
- Justification for type of information:
- Data is summarized based on the available information from various test chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- WoE report is based on 3 acute dermal toxicity studies as- WoE 2, WoE 3 and WoE 4
Acute dermal toxicity test was carried out to study the effects of the test chemicals on rodents. - GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- other: 2.Rat, 3.Rabbit,4.Rabbit
- Strain:
- other: 2.Sprague-Dawley,3.Not specified,4.Not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 2. TEST ANIMALS
- Source:
2. National Institute of Biosciences, Pune.
3.Not specified
4.Not specified
- Females (if applicable) nulliparous and non-pregnant: No data available
- Age at study initiation:
2.Young adult male and female rats aged between 8 – 12 weeks were used.
3.Not specified
4.Not specified
- Weight at study initiation:
2.The weight range of approximately 217.8 to 251.8 grams at initiation of dosing.
3.Not specified
4.Not specified
Body weights at the start :
Male
Mean : 246.46 g (= 100 %)
Minimum : 238.5 g (- 3.23 %)
Maximum : 251.8 g (+ 2.17 %)
Total No. of animals : 5
Female
Mean : 221.36 g (= 100 %)
Minimum : 217.8 g (- 1.61 %)
Maximum : 224.3 g (+ 1.33 %)
Total No. of animals : 5
3.Not specified
4.Not specified
- Identification:
2.Each rat was individually identified by the cage number.
3.Not specified
4.Not specified
- Fasting period before study: No data available
- Housing:
2.The rats were individually housed in polycarbonate cages with paddy husk as bedding.
3.Not specified
4.Not specified
- Diet (e.g. ad libitum):
2.Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
3.Not specified
4.Not specified
- Water (e.g. ad libitum):
2.Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
3.Not specified
4.Not specified
- Acclimation period:
2. 5 days.
3.Not specified
4.Not specified
2.ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 22.3 degree centigrade.
- Humidity (%): 54.8% to 58.8%.
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
3.ENVIRONMENTAL CONDITIONS-Not specified
4.ENVIRONMENTAL CONDITIONS-Not specified
IN-LIFE DATES: 18-07-2017 to 02-08-2017 - Type of coverage:
- other: 2.Semiocclusive 3.Not specified,4.Not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- 2.TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.
3.Not specified
4.Not specified
2.REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.
3.Not specified
4.Not specified
2. TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: No data available
- For solids, paste formed: No data available
3.Not specified
4.Not specified
VEHICLE
- Amount(s) applied (volume or weight with unit): No data available
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Duration of exposure:
- 2 .24 hr
3.Not specified
4.Not specified - Doses:
- 2.A single dose of 2000 mg of the test item per kilogram of body weight was administered to ten rats (five males and five females).
3.Not specified
4.Not specified - No. of animals per sex per dose:
- 2. 10 (5/sex).
3.Not specified
4. 3 rabbits - Control animals:
- not specified
- Details on study design:
- 2.Study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: Yes
- Other examinations performed:
Clinical Observations and General Appearance:
Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Evaluation of Dermal Reaction:
Dermal reaction was observed daily for study period of 14 days.
Body weights:
Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.
Gross Pathology:
Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology:
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed.
3.Study design :Not specified
4.Study design :Not specified - Statistics:
- Not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- not specified
- Remarks on result:
- other: No other details observed
- Mortality:
- 2.Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days.
Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days
3.No mortality was observed
4.No mortality was observed - Clinical signs:
- other: 2.Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not res
- Gross pathology:
- 2.Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group
3.Not specified
4.Not specified - Other findings:
- 2.- Other observations:
Evaluation of Dermal Reaction
Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
3.Not specified
4.Not specified - Interpretation of results:
- other: Not classified
- Conclusions:
- According to CLP regulation, the test chemical cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw.
- Executive summary:
In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below –
The study now reported was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats.
The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days.
Animals exhibited normal body weight gain through the study period of 14 days.
Gross pathological examination did not reveal any abnormalities attributable to the treatment.
It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be greater than 2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant.
The above study is supported with another study conducted on rabbit The test chemical was applied onto the skin of rabbits.
The acute dermal LD50 for test chemical was determined to be greater than 5000mg/kg.
Based on value the chemical was not classified as per CLP regulations.
The above study further supported with another study conducted on rabbits, The animals were treated with test chemical. No mortality was observed in treated rabbits. Therefore, LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with test chemical dermally.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Data is Klimisch 1 and from experimental study report.
Additional information
Acute toxicity:Oral Route
The acute oral toxicity of test chemical was performed in Sprague-Dawley rats . For this purpose, the product was administered once by gavage as a 50% solution in aqua dest . in doses of 5620, 6810, 8250 and 10000 mg/kg .
The median lethal dose (LD 50) after 14 days was observed to be8980 (8440 - 9710) mg/kgin male and female rats.Inmale animals LD50 value was observed to be 9140 (8350 - 10510) mg/kgwhereas infemale animals ,8820 (7960 - 10090) mg/kg.
From the above study it is concluded that test chemicaldoes not exhibits acute toxicity by the oral route.
The study is supported by an acute oral toxicity of test chemical was performed in NMRI mice . For this purpose, the product was administered once by gavage as a 50% solution in distilled water in doses of 10000 mg/kg once by gavage.
No death was observed at a dose of 10000 mg/kg bw in male and female mice,hence LD50 value was considered to be >10000 mg/kg bw
From the above studies it is concluded that test chemical does not exhibits acute toxicity by the oral route.
Acute Toxicity:Inhalation
The particle size distribution of the test substance was found to vary in the size of 53-500 µm, so the potential for the generation of inhalable forms is low.Moreover the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore acute toxicity by inhalation route was considered to be waived.
Acute toxicity:Dermal
In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for structurally similar read across chemicals.The studies are summarized as below:
The study now reported was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats.
The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days.
Animals exhibited normal body weight gain through the study period of 14 days.
Gross pathological examination did not reveal any abnormalities attributable to the treatment.
It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be greater than 2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant.
The above study is supported with another study conducted on rabbit The test chemical was applied onto the skin of rabbits.
The acute dermal LD50 for test chemical was determined to be greater than 5000mg/kg.
Based on value the chemical was not classified as per CLP regulations.
The above study further supported with another study conducted on rabbits, The animals were treated with test chemical. No mortality was observed in treated rabbits. Therefore, LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with test chemical dermally.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.
Justification for classification or non-classification
Based upon the studies reviewed it can be concluded that, the test chemicalis not expected to show acute toxicity effect by the oral, inhalation and dermal route and thus will not be considered for further classification.
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.