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EC number: 275-148-4 | CAS number: 71033-19-7
- 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
Acute oral toxicity, LD50: > 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:
- From the 26th of April to the 19th of May, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Test conducted according to an internationally accepted test guideline.
- 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 (Acute Toxicity (Oral))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Species and strain: Rat, Hsd: Sprague Dawley SD
Sex: Females (nulliparous and non-pregnant)
Age and weight at order: 6-7 weeks old; 150-174 grams
Supplier: Envigo RMS srl, San Pietro al Natisone (UD), Italy
Date of arrival: 07 April 2016
Weight range at arrival: 153.2-162.3 grams
Acclimatisation period: At least 5 days
Veterinary health check: During acclimatisation period
ENVIRONMENTAL CONDITIONS
Animals per cage: 3 during the study; up to 5 during acclimatisation
Housing: Polisulphone solid bottomed cages measuring 59.5×38×20 cm with nesting material provided into suitable bedding bags
Cage control: Daily inspected and changed as necessary (at least 3 times/week)
Water: Drinking water supplied to each cage via a water bottle
Water: supply ad libitum
Diet: 4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy)
Diet supply: ad libitum throughout the study except for the dosing procedure
Room: lighting Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air: changes Approximately 15 to 20 air changes per hour
Temperature range: 22 °C ± 2 °C
Relative humidity range: 55 % ± 15 %
Selection/Allocation
Random at arrival. The body weight of each individual was within 20% of the group’s mean. Animals were unequivocally numbered within the study.
The animal number together with the study number ensured a unique animal numbering for any study employing computerised data collection. The computer system used in this study was Pristima version 6.3.2.
Animal identification
Animals were permanently identified, following arrival, by a combination of ear notch (units) and tattoo on the hind feet. Animals were identified by odd numbers.
Fasting procedure
Food was removed from the cages overnight prior to dosing (Day -1) and was made available approximately 4 hours after dosing. - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5%
- Details on oral exposure:
- A first group of 3 female animals was dosed at a level of 2000 mg/kg (Step 1).
A second sub-group, similarly composed, was then dosed at the same dose level (Step 2).
No further doses were investigated since the objective of the study had been achieved (no mortality).
Frequency of treatment
Animals were dosed once only on Day 1.
Dose calculation
On the day of dosing (Day 1), the amount of the formulated test item to be administered was
calculated for each fasted animal according to body weight.
Dosing method
The formulated test item was administered, by gavage, at a dose volume of 10mL/kg using a
plastic feeding tube attached to a graded syringe. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 female per group
- Details on study design:
- TREATMENT (mg/kg)
2000 in terms of test item corrected for purity (77.1%)
Rat Numbers Females (odd)
7, 9, 11 (Group 2 - Step 1)
19, 21, 23 (Group 4 - Step 2)
OBSERVATION
Mortality and morbidity
Throughout the study all animals were checked twice daily.
Clinical signs
Animals were observed for clinical signs as indicated below:
– Day of dosing
· Session 1: on dosing
· Session 2: approximately 0.5 hour after dosing
· Session 3: approximately 2 hours after dosing
· Session 4: approximately 4 hours after dosing
– Daily thereafter for a total of 14 days (Session 1).
Body weight
All animals were weighed at allocation to the study (Day -1), on the day of dosing (Day 1) and on Days 2, 8 and 15.
Body weight change calculated for Days 2, 8 and 15 of the dosing phase was relevant to Day 1 of the phase.
TERMINAL STUDY
Termination
All animals were sacrificed on Day 15.
Euthanasia method
Animals were sacrificed by carbon dioxide narcosis.
Necropsy procedure
Necropsy was carried out on all animals (gross necropsy examination for both external and
internal abnormalities, with particular attention to the gastro-intestinal tract). - Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality occurred in all animals on Day 2 of study, in the first group of animals initially dosed at 2000 mg/kg (Group 2, Step 1).
No death occurred and no clinical signs were observed in the further group of 3 females dosed at the same dose level (Group 4, Step 2). - Clinical signs:
- A yellow staining on the tail was observed in all animals on Day 2 of study, in the first group of animals initially dosed at 2000 mg/kg (Group 2, Step 1).
- Body weight:
- Changes in body weight observed during the study were within the expected range for this strain and age of animals.
- Gross pathology:
- No abnormalities were observed at necropsy examination performed on all animals dosed at 2000mg/kg (Groups 2 and 4) at the end of the observation period, with the exception of one animal (no. 19, Group 4) that showed red staining on the dorsum.
- Interpretation of results:
- not classified
- Remarks:
- Classification criteria according to the CLP Regulation 1272/2008 and its amendments
- Conclusions:
- No toxic effects at one dose, in rats: 2000 mg/kg.
- Executive summary:
Method
The acute toxicity of the substance was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period, according to OECD 423, in GLP.
A first group of 3 female animals was initially dosed at 2000 mg/kg (Step 1).
A second group of 3 female animals was then dosed at the same dose level (Step 2).
Observations
No mortality occurred. The only finding observed was yellow staining on tail in all animals on Day 2 of the study.
No death occurred and no clinical signs were noted.
Body weight changes recorded during the study were within the expected range for this strain and age of animals. No abnormalities were observed at necropsy examination performed at the end of the observation period on animals of both groups, with the exception of animal no. 19 (Group 4), that showed red staining on the dorsum.
Conclusion
These results indicate that the test item did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute Oral Toxicity
The acute toxicity of the substance was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period, according to OECD 423, in GLP..
Results indicate that the test item did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight.
Justification for classification or non-classification
Acute oral toxicity
According to the CLP Regulation 1272/2008/EC, 3.1.2.1 section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1:
Oral (mg/kg body weight)
Category 1: LD50 ≤ 5
Category 2: 5 <LD50 ≤ 50
Category 3: 50 < LD50 ≤ 300
Category 4: 300 < LD50 ≤ 2 000
The oral LD50 values are > 2000 mg/kg/body weight.
The substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n.1272/2008.
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