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EC number: 223-496-2 | CAS number: 3923-79-3
- 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
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Endpoint summary
Administrative data
Description of key information
In the key Acute Oral Toxicity Study, the LD50 was >2000 mg/kg bw in male and female rats.
In the key acute dermal toxicity study, the LD50 was >3300 mg/kg bw in male and female rats. In a supporting study in male and female rats according to OECD guideline 402, the LD50 was >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:
- according to guideline
- Guideline:
- other: EEC Directive 92/69, 1992
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adult male and female animals were used with a comparable body weight at the start of the study (150 g - 300 g). The animals were identified using cage cards and group identification was done by tail marking. The animals were housed in fully air-conditioned rooms with a central air-conditioning of 20 - 24°C for temperature and a relative humidity between 30 - 70%. The day/night rhythm was 12 h dark and 12 h light. Animals were housed single in stainless steel wire mesh cages with no bedding in the cages (sawdust in the waste trays). A standard laboratory diet was used and tap water was available ad libitum.
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Aqueous formulation corresponds to the physiological medium.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Single oral administration by gavage (solution).
Observation period: 14 days
Acclimatization period of the animals: at least 1 week. The animals were given no feed at least 16 hours before administration, but water was available ad libitum.
Individually body weight determination shortly before application, weekly thereafter and at the end of the study (before fasting period).
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for general observations and mortality was made twice each workday and once on weekends and on public holidays for general observations and for any dead or moribund animals.
Necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy with gross-pathology examination. Necropsy of all animals that died before as soon as possible. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- no abnormalities
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Reliable without restrictions
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- basic information given; scientifically acceptable
- Principles of method if other than guideline:
- In accordance with the techniques specified in the Regulations for the Enforcement of the Federal Hazardous Substances Act (Code of Federal Regulatioris, Title 16, Part 1500).
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The rabbits were individually identified by means of numbered ear tags.
The rabbits were housed in individual stainless steel cages suspended above the droppings. Food, consisting of Purina Laboratory Chow, and water were available at all times. The animals were kept on a 12-hour light/12-hour dark cycle.
Weight range 2431 to 3000 gram. - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The rabbits were acclimated to the laboratory for at least 10 days before being dosed. The dose was applied to the abdominal skin area from which the fur had been previously removed with electric clippers. The abdominal skin area of half of the rabbits in the group was abraded by making a series of longitudinal minor epidermal incisions placed two to three centimeters apart, using a hypodermic needle as a cutting tool. The abrasions were sufficiently deep to penetrate the epidermis but not to induce bleeding. The skin of the remaining rabbits in the group remained intact. An equal number of males and females were assigned to the intact skin and abraded skin sub-groups.
The undiluted sample was applied at a dosage level of 3.0 ml/kg of body weight. The sample was introduced into a sleeve of rubber dental damming which was wrapped around the trunk of the animal and secured with staples. An outer layer of gauze and tape was placed around the trunk of the animal. The rabbit was restrained for 24 hours in a Newmann harness.
At the end of the 24-hour exposure period the binder was removed and any unabsorbed sample remaining on the skin was removed by gentle sponging with a moistened towel.
Each rabbit was examined throughly for gross signs of systemic toxicity and dermal irritation.
All rabbits were maintained for 14 days following completion of the exposure period. Examinations for gross signs of systemic toxicity and dermal irritation were carried out at frequent intervals during this period. At the end of the 14-day observation period the rabbits were weighed, sacrificed by T-61 overdose, and a gross necropsy was performed on each animal. - Duration of exposure:
- 24 hours
- Doses:
- 3.0 mL/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 300 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- none
- Clinical signs:
- other: Upon removal of the binders from the animals, the exposed area and binder appeared dry with no sample apparent on any of the animals. This proved evidence of complete dermal absorption of the sample. Irritative effects noted during the study included eryt
- Gross pathology:
- Gross necropsies performed at the termination of the study revealed pitted kidneys in one animal. No other gross-pathological alterations or lesions were noted in any of the rabbits.
Reference
Body weight changes (dose level: 3.0 ml/kg):
Rabbit No. | Sex | Skin | Body weight | |||
Intact | Abraded | Start (gm) | Finish (gm) | Change (gm) | ||
1 | male | x | 2691 | 2971 | 280 | |
2 | male | x | 2964 | 3292 | 328 | |
3 | male | x | 3000 | 3531 | 531 | |
4 | female | x | 2998 | 3327 | 329 | |
5 | male | x | 2940 | 3069 | 129 | |
6 | male | x | 2995 | 3215 | 220 | |
7 | female | x | 2999 | 3302 | 303 | |
8 | female | x | 2599 | 2709 | 110 | |
9 | female | x | 2431 | 3024 | 593 | |
10 | female | x | 2775 | 3145 | 370 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 3 300 mg/kg bw
- Quality of whole database:
- Study well documented, meets generally accepted scientific principles, acceptable for assessment
Additional information
Key, Acute oral toxicity, RL1
BASF (1995) reported an acute oral LD50 value of > 2000 mg/kg for male and female rats. Wistar rats were administered (gavage) a aqueous formulation of the test chemical in a concentration of 2000 mg/kg. No mortalities and no clinical signs were reported. Necropsy of the surviving animals showed no abnormalities.
For acute inhalation toxicity only an orientating information is available which is not used for classification.
Key, Acute inhalation toxicity, RL2
BASF (1973) reported an inhalation hazard test with Fixapret CPN (CAS: 1854-26-8). Inhalation exposure for 8 h to an atmosphere enriched with test substance vapors from a 45% aqueous solution of the test substance (conc. 6.93 mg/L) at 20°C caused no mortalities and no adverse systemic effects in rats, but some signs of dyspnea and irritation of mucous membrane.
Supporting, Acute inhalation toxicity, RL2
The Springborne Institute (1980) reported about an inhalation safety screen of Textile Resin NFU in rats. Male and female Harlan rats were offered an inhalation vapour for 1 hour (no data about the concentration). No mortalities and no gross-pathological findings were reported. Clinical signs were nasal irritation during the early parts of exposure (animals appearaed normal during most of the exposure and for the next 14 days).
Key, Acute dermal toxicity, RL2
Hill Top Research Inc. (1979) reported about the acute dermal toxicity of Textile NFU. Male and female New Zealand White rabbits were covered occlusive with the undiluted test substance for 24 hours. The concentration used was 3 mL/kg (3300 mg/kg bw). No mortalities were seen. The irritative effects noted during the study included eythema, atonia and desquamation. Gross necropsies performed at the termination of the study revealed pitted kidneys in one animal. No other gross-pathological alterations or lesions were noted in any of the animal. The acute dermal LD50 value was found to be > 3300 mg/kg bw.
Supporting, Acute dermal toxicity, RL2
BASF (2009) reported an acute dermal toxicity study with the structure-related compound Fixapret CP (CAS: 92908-35-5). In this experiment, male and female Wistar rats were covered semiocclusive with the test substance for 24 hours. The concentration used was 2000 mg/kg. No mortalities, no clinical signs and no gross-pathological changes were noted. Local effect: slightly yellowish discoloration of the applicate site. The acute dermal LD50 value was > 2000 mg/kg bw.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data, the test item is not classified and labelled for acute toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.
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.
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