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EC number: 916-918-8 | 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
The LD50 (oral, gavage) of the test substance to male/female rats is 934 mg/kg bw corresponding to 560 mg/kg bw based on active ingredient. The substance is classified as Category 4.
In an acute dermal toxicity study in rabbits, no adverse effects were observed. The dermal LD50 is above 2000 mg/kg bw.
No study on acute toxicity via inhalation was conducted to an unlikely exposure.
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:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DR. K. THOMAE GMBH
- Weight at study initiation:
males (161- 178) g
females (172 - 181) g
- Fasting period before study: the animals are given no feed 16 hours before administration, but water is available ad libitum.
- Housing: 5 rat housing in a stainless steel wire mesh cages, type DK-III
- Diet: kliba-labordiaet. fa. klingentalmuehle ag ch-4303 ka i seraugst, switzerland.ad libitum
- Water: tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): fully air-conditioned room by central air-conditioning system
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light between 6:00 AM to 6:00 PM - Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Details on oral exposure:
- Form of administration: suspension
Amounts administered:
- Dose (mg/kg) 1210 825 562
- Conc. (w/v) 12.10 8.25 5.62
- Adm. vol. (ml/kg) 10 10 10 - Doses:
- 562, 825, 1210 mg/kg bw
- No. of animals per sex per dose:
- 5 per sex per doses
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14
- Frequency of observations and weighing: recording of signs and symptoms several times on the day of administration, at least once each workday. check for moribund and dead animals twice each workday and once on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: gross-pathological examination - Statistics:
- The slope factor was calculated by probit analysis, cambridge university press, 3rd ed., 1971
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 934 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 785 - < 1 145
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 560.4 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- yes
- Clinical signs:
- other: dyspnoea, apathy, staggering, urine red, salivation, poor general state
- Gross pathology:
- snout, paws and mucosa of stomach discolored by the test substance
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 (oral, gavage) of the test substance to male/female rats is 934 mg/kg bw corresponding to 560 mg/kg bw based on active ingredient. The substance is classified as Category 4.
- Executive summary:
The substance has been tested for acute toxicity by oral route. The substance was administered by gavage at nominal concentrations of 562, 825 and 1210 mg/kg bw to 5 females and 5 males rats. Signs and symptoms are registered several times on the day of administration and at least once each workday. The check for moribund and dead animals was registered twice each workday and once on holidays. Under the test conditions the substance couse dyspnoea, apathy, staggering, urine red, salivation and poor general state. The autopsy reveals snout, paws and mucosa of stomach discolored by the test substance. The LD50 of the test substance is 934 mg/kg b.w. corresponding to 560.4 mg/kg b.w based on active ingredient.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 934 mg/kg bw
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:
- 1977/78
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR Part 1500 - HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND ENFORCEMENT REGULATIONS
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: local supplier
- Age at study initiation: 8 to 11 weeks
- Housing: 1/cage in suspended wire mesh cages (30" x 1.8" x 18") in temperature controlled rooms
- Diet (e.g. ad libitum): Purina Rabbit Chow ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 7 days - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure:200 square cm
- % coverage : 10% of the body surface.
- Type of wrap if used: gauze patches and impervious material
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposure site was washed with warm tap water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg bw
Twenty-four hours prior to dosing the backs of the rabbits were clipped free of fur with an Oster ANG-RA clipper head designed specifically for clipping rabbits. The rabbits were returned to their cages overnight. Just prior to dosing one half of the rabbits were abraded with a 21 gauge bent tip needle. The abrasions, made every 2 to 3 cm longitudinally, scratched the stratum corneum, but did not disturb the derma or produce bleeding.
The test material was applied to the backs of two male and two female rabbits at a dose of 2.0 g/kg. The test site was covered with gauze and the trunk was wrapped with impervious material for 24 hours. Following removal of the binder at 24 hours, the test site was washed with warm tap water. One hour after washing the test sites were graded for skin irritation according to the attached scale. Skin sites were read again at 7 and 14 days. Body weights were recorded pretest and at 7 and 14 days. The rabbits were observed daily for 14 days for signs of toxicity or mortality. Necropsies were performed on all rabbits. - Duration of exposure:
- The test material was kept in contact with the skin for 24 hours, at which time the wrappings were removed.
- Doses:
- 2.0 g/kg bw
- No. of animals per sex per dose:
- 2
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weigthing: Dermal reactions were scored at 25 hours, 7 and 14 days by the Draize scoring system. The rabbits were observed daily for 14 days for signs of toxicity, pharmcaological effects and mortality. Body weights were recorded pretest and in the survivors at 7 and 14 days.
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- 0/2 male
0/2 female - Clinical signs:
- other: no systemic or local effects
- Gross pathology:
- Liver purple: 1/4
Lungs purple: 2/4
Kidney Mottled: 2/4 - Interpretation of results:
- other: no dermal toxicity observed
- Conclusions:
- The test material is not toxic , as defined in 16 CFR 1500.3, at a dose level of 2.0 g/kg of body weight.
- Executive summary:
2 males and 2 females New Zealand White rabbits were dosed at 2.0 g/kg of body weight. The substance was prepared at 50% w/v in distilled water. The test material was applied once dermally to the prepared site under gauze patche and was kept in contact with the skin for 24 hours. The exposure site was washed with warm tap water to remove excess material.
The rabbits were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality. Body weights were recorded pretest and in the survivors at 7 and 14 days. Animals were generally healthy throughout the 14 day test period. No erythema or edema were observed either on intact or abraded skin during the 14 days observation period. Necropsies of animals sacrificed on Day 14 revealed purple liver and lungs in one or two rabbits, respectively and mottled kidneys in two rabbits. There were no other abnormalities.
In conclusion, all animals survived this test at 2.0 g/kg of body weight and the test material is considered not toxic at this dose level.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
The substance has been tested for acute toxicity by oral route. The substance was administered by gavage at nominal concentrations of 562, 825 and 1210 mg/kg bw to 5 females and 5 males rats. Signs and symptoms are registered several times on the day of administration and at least once each workday. The check for moribund and dead animals was registered twice each workday and once on holidays. Under the test conditions the substance couse dyspnoea, apathy, staggering, urine red, salivation and poor general state. The autopsy reveals snout, paws and mucosa of stomach discolored by the test substance. The LD50 of the test substance is 934 mg/kg b.w. corresponding to 560.4 mg/kg b.w based on active ingredient.
Acute dermal toxicity was investigated in 2 males and 2 females New Zealand White rabbits at a single dose level 2000 mg/kg of body weight. The substance was prepared at 50% w/v in distilled water. The test material was applied once dermally to both, intact and abraded skin for 24 hours. The exposure site was washed with warm tap water to remove excess material.
The rabbits were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality. Body weights were recorded pretest and in the survivors at 7 and 14 days. Animals were generally healthy throughout the 14 day test period. No erythema or edema were observed either on intact or abraded skin during the 14 days observation period. Necropsies of animals sacrificed on Day 14 revealed purple liver and lungs in one or two rabbits, respectively and mottled kidneys in two rabbits. There were no other abnormalities.
In conclusion, all animals survived this test at 2000 mg/kg of body weight and the test material is considered not toxic at this dose level.
Justification for classification or non-classification
GHS Category 4 - H302
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