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EC number: 603-493-6 | CAS number: 131560-11-7
- 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
In an OECD 423 acute oral toxicity study in rats, the LD 50 was found to be greater than 200 mg/kg bw and less or equal to 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
- Study period:
- 1999
- 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)
- Version / remarks:
- March 22, 1996
- GLP compliance:
- yes
- Remarks:
- Study director
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Manufacturing date: August 1998
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, exclusion of oxygen (under nitrogen)
- Solubility and stability of the test substance in the solvent: proven good solubility
FORM AS APPLIED IN THE TEST: solution - Species:
- rat
- Strain:
- Wistar
- Remarks:
- chbb: thorn
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: young
- Weight at study initiation: 177-180 g (male), 175-181 g (female)
- Fasting period before study: animals were given no feed at least 16 hours before administration, but water was available ad libitum
- Housing: single in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- bidest
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- 200 mg/kg (2 kg/ 100 mL), 2000 mg/kg (20 kg/ 100 mL) only tested in three separate females
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days for the 200 mg/kg dose group; 1 day for the 2000 mg/kg dose group
- Frequency of weighing: shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period)
- Clinical signs including body weight recorded several times on the day of administration
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - <= 2 000 mg/kg bw
- Mortality:
- 2000 mg/kg dose group: all animals died 1 day after application
200 mg/kg dose group: delayed mortality observed in 1 male and 1 female rat, which died 6 and 11 days after application, respectively - Clinical signs:
- other: 2000 mg/kg dose group: impaired general state and dyspnoea 200 mg/kg dose group: impaired and poor general state, dyspnoea, gasping, apathy, staggering, spastic gait, diarrhea, exsiccosis, extended abdomen, red discoloured urine, compulsary gnawing and re
- Gross pathology:
- - dilation of the stomach and of the small and large intestine with gaseous or watery contents and erythema of the small intestine
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 200 mg/kg and less or equal to 2000 mg/kg body weight.
Reference
Table 1: Symptoms of the male animals (cageside observations)
Dose (mg/kg) 200 |
numer animals (n) with symptoms |
time period showing symptoms |
Impaired general state |
3/3 |
h1 d1-d2 |
Poor general state |
3/3 |
d1-d2 |
Dyspnoea |
3/3 |
h1-h4 d5-d9 |
Gasping |
1/3 |
h1-d2 |
Apathy |
3/3 |
h1-h4 |
Staggering |
1/3 |
h1-h4 |
Piloerection |
3/3 |
h1-d9 |
Diarrhea |
1/3 |
h3-h4 |
Exsiccosis |
1/3 |
d5-d9 |
Weight reduction |
1/3 |
d7-d9 |
Extended abdomen |
1/3 |
d9 |
Red clammy snout |
1/3 |
d1 |
h: hour, d: day
Table 2: Symptoms of the female animals (cageside observations)
Dose (mg/kg) |
200 |
2000 |
||
|
numer animals (n) with symptoms |
time period showing symptoms |
numer animals (n) with symptoms |
time period showing symptoms |
Impaired general state |
1/3 |
d6-d9 |
3/3 |
h2-h4 |
Poor general state |
3/3 |
h1-h5 d2-d3 |
|
|
Dyspnoea |
3/3 |
d2-d3 d2-d9 |
3/3 |
h2-h4 |
Apathy |
3/3 |
h1-h5 d2-d3 |
|
|
Staggering |
3/3 |
h5 d2-d3 |
|
|
Spastic gait |
1/3 |
d3 |
|
|
Piloerection |
3/3 |
h5 d2-d9 |
|
|
Smeared fur |
2/3 |
d2-d3 |
|
|
Diarrhea |
3/3 |
h5 |
|
|
Exsiccosis |
2/3 |
d2-d3 |
|
|
Discoloured urine red |
1/3 |
d3 |
|
|
compulsory gnawing |
3/3 |
h1-h2 |
|
|
Red clammy snout |
2/3 |
d2-d3 |
|
|
h: hour, d: day
Table 3: Mortality of the female animais (cumulative)
Dose |
(mg/kg): |
200 |
No.of |
animals: |
3 |
after: |
|
|
h0 |
|
0 |
d11 |
|
1 |
d14 |
|
1 |
Table 4: Mortality of the female animais (cumulative)
Dose |
(mg/kg): |
200 |
2000 |
No.of |
animals: |
3 |
3 |
after: |
|
|
|
d1 |
|
0 |
3 |
d6 |
|
1 |
|
d14 |
|
1 |
|
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 200 mg/kg bw
Additional information
Oral route
The study was performed to assess the acute toxicity following oral administration of the test substance, applied as a solution in aqua bidest., in Wistar rats. The study procedure was based on the OECD 423.
To a group of six fasted animals <three males and three females) a single oral dose of the test material preparation in aqua bidest. at a dose level of 200 mg/kg body weight was given. Another group of three female animals was treated in the same way with a dose of 2000 mg/kg body weight.
Signs of toxicity noted in the 200 mg/kg dose group comprised impaired and poor general state, dyspnoea, gasping, apathy, staggering, spastic gait, diarrhea, exsiccosis, extended abdomen, red discoloured urine, compulsary gnawing and red clammy snout. The surviving animals appeared normal within 10 days after application. The animals of the 2000 mg/kg dose group showed impaired general state and dyspnoea.
The expected body weight gain was generally observed in the course of the study, with the exception of 1 male and 1 female rat of the 200 mg/kg dose group, which showed weight reduction uip to death on day 6 or 11.
All animais of the 2000 mg/kg dose group were found dead 1 day after application. A delayed mortality was observed in 1 male and 1 female rat of the 200 mg/kg dose group, which died 6 respectively 11 days after application. Necropsy findings of the animals that died comprised dilation of the stomach and of the small and large intestine with gaseous or watery contents and erythema of the small intestine.
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.
Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 200 mg/kg and less or equal to 2000 mg/kg body weight.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008, as amended for the thirteenth time in Regulation (EU) No 2018/1480. As a result the substance is classified for acute toxicity, Cat. 3, H301: Toxic if swallowed under Regulation (EC) No. 1272/2008.
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