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EC number: 824-801-7 | CAS number: 1093628-27-3
- 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
There are good quality GLP Guidelines studies for acute toxicity by the oral and dermal routes. The dermal routee being the most likely route of exposure during the manufacture and use of the substance.
Acute oral toxicity, the LD50 in rats is greater than 300mg/kg bodyweight and less than 2000mg/kg bodyweight. This is CLP(GHS) Category 4.
Acute dermal toxicity, the dermal LD50 in rats is greater than 2000mg/kg bodyweight. In the absence of any indication of toxicity this is considered to not meet any CLP or GHS criteria for classification for acute dermal toxicity.
Acute inhalation toxicity, the test substance is manufactured and sold as a solution in 2-ethylhexanol, inhalation exposure is not expected to be a normal route of exposure. Therefore acute inhalation testing has not be performed, the study is waived as not scientifically justified.
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:
- Study started 5th September 2006 - Reported 16th February 2017
- 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:
- no
- Specific details on test material used for the study:
- Identity Witconate P-1460
Description Light brown paste
Batch number 2140-5901
Activity 88.8 %
Stability of test item Stable under storage conditions.
Expiry date 07-APR-2007
Stability of test item dilution Unknown in water; excluded from the statement of
compliance.
Storage conditions At room temperature (range of 20 +/- 5 °C), light protected. - Species:
- rat
- Strain:
- Wistar
- Remarks:
- HanRCC:WIST (SEF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test system: Rat, Hacc:WlST (SPF)
Rationale Recognized by the international guidelines as a recommended test system.
Source: RCC Ltd, Laboratory Animal Services CH-4414 Füllinsdorf / Switzerland
Number of animals per group 3 females
Total number of animals 12 females
Age when treated 11 weeks
Identification: Unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination, Only animals without any visible signs of illness were used for the study.
HUSBANDRY
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22 +/- 3 °C and for relative humidity between 30-70 % (values above 70 % during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no, 36/06 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad Iibitum. Results of analyses for contaminants are archived at RCC Ltd.
Water: Community tap water from Füllinsdorf ad Iibitum. Results of ' bacteriological, chemical and contaminant analyses are archived at RCC Ltd. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Purified water prepared at RCC Ltd (deionised water which was processed and treated by the PURELAB Option-R unit. This latter links four purification technologies: reverse osmosis, adsorption. ion-exchange and photo oxidation).
- Details on oral exposure:
- Dose levels are in terms of the test item as supplied by the sponsor.
The dose formulations were made shortly before each dosing occasion using a magnetic stirrer, a spatula and an Ultrasonic bath as homogenizers.
The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight/volume).
Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
TREATMENT
The animals received a single dose of the test item by oral gavage administration after being fasted for approximately 18 to 19 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.
The dosing volume was 10 ml/kg body weight.
TREATMENT
The animals received a single dose of the test item by oral gavage administration after being fasted for approximately 18 to 19 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.
The dosing volume was 10 ml/kg body weight. - Doses:
- Two groups of three female rats were treated at the start dose of 2000 mg/kg body weight. Due to spontaneous death of two of the animals of the latter dosing group, the study was extended to a lower dose level as requested by the referred guideline. Thus, two further groups of three animals were treated at the dosage of 300 mg/kg body weight.
- No. of animals per sex per dose:
- 3 females per group
- Control animals:
- no
- Details on study design:
- Two groups of three female rats were treated at the start dose of 2000 mg/kg body weight. Due to spontaneous death of two of the animals of the latter dosing group, the study was extended to a lower dose level as requested by the referred guideline. Thus, two further groups of three animals were treated at the dosage of 300 mg/kg body weight.
OBSERVATIONS
Mortality/Viability: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
NECROPSY
All animals which died spontaneously during the observation period were necropsied as soon as they were found dead. '
All surviving animals were killed at the end of the observation period by Carbon dioxide asphyxiation and discarded after macroscopic examinations were performed. No organs or tissues were retained.
Body weights: On test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. Al abnormalities were recorded. - Statistics:
- No statistical analysis was used.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The following animals were treated and percentage of mortality was observed:
6 females treated at 2000 mg/kg 33 %
6 females treated at 300 mg/kg 0 %
Two animals treated at 2000 mg/kg Witconate P-1460 were found dead two days after test item administration. Four of the animals treated at 2000 mg/kg and all animals treated at 300 mg/kg survived until the end of the study period. - Clinical signs:
- other: A hunched posture was noted in all animals treated at 2000 mg/kg from the 1-hour reading up to day 2 or 3 with the exception of the 5-hour reading for three out of the 6 animals. In addition, a slightly or moderately ruffled fur was observed in three of t
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The median lethal dose of Witconate P-1460 after single oral administration to female rats, observed over a period of 14 days is:
300 mg/kg body weight < LD50 (female rat) < 2000 mg/kg body weight
The mortalities seen at 2000mg/kg together with the lack of mortalities at 300 mg/kg bodyweight result in an EU CLP/GHS classification of Category 4 - Executive summary:
SUMMARY
Four groups, each of three female Hacc:WlST (SPF) rats, were treated with Witconate P-1460 by oral gavage administration at a dosage of 2000 mglkg or 300 mglkg body weight.
The test item was diluted in vehicle (purified water) at a concentration of 0.2 gImL or 0.03 g/mL and administered at a dosing volume of 10 mL/kg.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2 -15.
Body weights were recorded on day1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
The following animals were treated and percentage of mortality was observed:
6 females treated at 2000 mglkg 33 %
6 females treated at 300 mglkg 0 %
Two animals treated at 2000 mglkg Witconate P-1460 were found dead two days after test I item administration. Four of the animals treated at 2000 mglkg and all animals treated at 300
mg/kg survived until the end of the study period.
A hunched posture was noted in all animals treated at 2000 mglkg from the 1-hour reading up to day 2 or 3 with the exception of the 5-hour reading for three out of the 6 animals. In addition, a slightly or moderately ruffled fur was observed in three of these animals from the 3-hour reading up to the spontaneous death on day 3 or day 6 of the study. Soft/watery feces were also noted for these three animals 3—5 hours after dosing, and, they were found moderately sedated on day 2 of the study. From day 3 or 7 up to the end of the observation period the surviving animals treated at 2000 mglkg showed no clinical findings.
The animals treated at 300 mglkg were observed in a hunched posture from the 2-hour reading up to the end of the day of dosing or up to day 2. Thereafter, no clinical signs were noted up to the end of the observation period.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were recorded at necropsy.
CONCLUSION
The median lethal dose of Witconate P-1460 after single oral administration to female rats, observed over a period of 14 days is:
300 mglkg body weight < LD50 (female rat) < 2000 mglkg body weight
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
- Quality of whole database:
- Th
Additional information
Justification for classification or non-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.
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