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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 439-020-3 | CAS number: -
- 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 and dermal toxicity was evaluated in GLP-conform studies according OECD guideline 401 and 402. Neither oral nor dermal administration of the test article at concentrations of 2000 mg/kg bw to rats caused unscheduled deaths. Thus, the LD50 for single oral and dermal administration is considered to be higher than 2000 mg/kg bw.
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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Principles of method if other than guideline:
- - weight of animals not mentioned
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HanBrl: Wist (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division CH-4414 Fullinsdorf / Switzerland
- Age at study initiation: 8-10 weeks
- Weight at study initiation: not mentioned
- fastened for 16-20h, access to water
- Housing: In groups of three per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
- Diet (e.g. ad libitum): maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) ad libitum. The females received from the 24-OCT-2001 until the 30-OCT-2001 batch no. 73/01, then to the end of the study batch no. 74/01. The male rats received batch no. 74/01. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum): Community tap-water, from Itingen ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES:
Delivery of Animals 24-OCT-2001 (females), 26-OCT-2001 (males)
Acclimatization 24-OCT to 30-OCT-2001 (females), 26-OCTto 1-NOV-2001 (males)
Treatment (first dose) 31-OCT-2001 (females, 2000 mg/kg), 2-NOV-2001 (males, 2000 mg/kg)
Observation 31-OCTto14-NOV-2001 (females), 2-NOVto16-NOV-2001 (males) - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial performed before experimental starting date.
- Lot/batch no. (if required): 424718/113701
DOSAGE PREPARATION (if unusual):
The preparations were made shortly before each dosing.
The test item was weighed into a tared glass beaker on a suitable precision balance and the
vehicle added (weight:volume). The mixtures were prepared using a ultra sound bath then a
magnetic stirrer.
Homogeneity of the test item in the vehicle was maintained during administration using a
magnetic stirrer. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males
3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation for mortality/viability daily during acclimatization, then twice daily during days 1-15, for clinical signs daily during acclimatization and then 5 times on day 1, daily during days 2-15, body weighing days 1, 8,15
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was used.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred during the study.
- Clinical signs:
- Slightly ruffled fur was evident in two females at 2000 mg/kg on the fist test day.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and
age. - Gross pathology:
- No macroscopic findings were observed at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of the test item after single oral administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat) >2000 mg/kg bodyweight
- Executive summary:
One group of three male or three female HanBrl: WIST (SPF) rats was treated by oral gavage with the test substance at 2000 mg/kg body weight. The test item was suspended in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs daily during the acclimatization period, four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded daily during the acclimatization period and together with clinical signs at the same time intervals on test day 1 and twice daily on test days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period. Slightly ruffled fur was evident in two females at 2000 mg/kg on the fist test day. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- according to GLP and OECD guideline 401
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- other: HanBrl: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd., Biotechnology and Animal Breeding Division, CH-4414 Fullinsdorf / Switzerland
- Age at study initiation: 9-11 weeks
- Weight at study initiation: not mentioned
- fastened for 16-20h, access to water
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH- 4132 Muttenz) during treatment and observation.
- Diet (e.g. ad libitum): maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) ad libitum. The females received from the 24-OCT-2001 until the 30-OCT-2001 batch no. 73/01, then to the end of the study batch no. 74/01. The male rats received batch no. 74/01. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum): Community tap-water, from Itingen ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES:
Experimental starting date 21-NOV-2001
Experimental completion date 12-DEC-2001
Delivery of animals 21-NOV-2001 (males and females)
Acclimatization 21-NOV to 27-NOV-2001 (males and females)
Treatment 28-NOV-2001 (males and females , 2000 mg/kg)
Observation 28-NOV to 12-DEC-2001 - Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction sites were assessed.
- Time after start of exposure: 24h
TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Constant volume or concentration used: yes
- concentration in vehicle: 0.5 g/ml
VEHICLE
- Amount(s) applied: 4 ml/kg bw
- Lot/batch no. (if required): 02938667 - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: for mortality/viability: Daily during acclimatization and twice daily during days 1-15, for weighing: On test days 1 (pre-administration), 8 and 15, for clinical signs: Daily during acclimatization and at least four times (see table of Mortality/Clinical Signs) on test day 1 after the test item administration. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was used.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- Slight erythema on the back was evident in three males and one female on test day 2 in an other female on test day 2 and 3. All other animals were without clinical signs.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and
age. - Gross pathology:
- No macroscopic findings were observed at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat) >2000 mg/kg bodyweight
- Executive summary:
A group of five male and five female HanBrl: WIST (SPF) rats was treated with the test item at 2000 mg/kg by dermal application. The test item was diluted in vehicle (corn oil) at a concentration of 0.5 g/ml and administered at a volume of 4 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1. During test days 2-15 it was recorded two times a day. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. Slight erythema on the back was evident in three males and one female on test day 2 additionally in an other female on test day 2 and 3. All other animals were without clinical signs. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- according to GLP and OECD guideline 402
Additional information
Performance and Observation
To evaluate acute oral and dermal toxicity of the test substance, two studies according OECD guideline 401 (CIBA 2001a) and 402 (CIBA 2001b) were performed.
In the first study, a group of three male or three female HanBrl: WIST (SPF) rats was treated by oral gavage with the test substance at 2000 mg/kg body weight. The test item was suspended in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. All animals survived until the end of the study period. Slightly ruffled fur was evident in two females at 2000 mg/kg on the first test day. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
In the second study, a group of five male and five female HanBrl: WIST (SPF) rats was treated with the test item at 2000 mg/kg by dermal application. The test item was diluted in vehicle (corn oil) at a concentration of 0.5 g/ml and administered at a volume of 4 ml/kg. No deaths occurred during the study. Slight erythema on the back were evident in three males and one female on test day 2 additionally in another female on test day 2 and 3. All other animals were without clinical signs. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
Discussion
Oral or dermal application of the test substance did not induce mortalities or any signs of toxicity. Also, body weight gain, food consumption and viability were unaffected. Application of the test item onto skin induced slight erythema. All symptoms resolved within the post observation period.
The test item is a viscous liquid and not inhalable. On account of this, a test of acute inhalative toxicity was not performed.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at the limit dose of 2000 mg/kg bw. As a result, the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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.