Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 917-631-0 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05-MAY-1997 to 11-JUL-1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- [2-Chloro-1,2,2-trifluoro-1-(trifluoromethyl)ethoxy] difluoroacetyl fluoride
- EC Number:
- 917-631-0
- Molecular formula:
- C5ClF9O2 and C5F10O2
- IUPAC Name:
- [2-Chloro-1,2,2-trifluoro-1-(trifluoromethyl)ethoxy] difluoroacetyl fluoride
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rats derived from the Sprague-Dawley strain (Crl: CD(SD)BR)
- Source: Charles River Italia S.p.A. / Via Indipendenza, 11 - 22050 CALCO (Lecco) / ITALY
- Age at study initiation: < 3 months for both sexes
- Weight at study initiation: 347 to 350 g for males and 225 to 300 g for females
- Fasting period before study: yes, about 16 h
- Housing: 5 animals/sex/cage in air-conditioned room (grill cages 40.5 x 38.5 x 18h cm with stainless steel feeder)
- Diet: ad libitum (GLP 4RF21 top certificate pelleted diet produced by Charles River italia’s feed licencee Mucedola S.r.L., Settimo Milanese)
- Water: ad libitum (filtered municipal water)
- Acclimation period: at least 5 days before the start of the test
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Humidity: 55 ± 10%
- Air changes: about 20 per hr filtered on HEPA 99.97%
- Photoperiod: 12 hrs dark / 12 hrs light (7 am. - 7 p.m.)
IN-LIFE DATES:
From 08-MAY-1997 to 22-MAY-1997 for females treated with doses of 83 and 58 mg/kg;
from 14-MAY-1997 to 14-MAY-1997 for females treated with a dose of 120 mg/kg;
from 30-MAY-1997 to 13-JUN-1997 for females treated with a dose of 69 mg/kg;
from 20-MAY-1997 to 03-JUN-1997 for males treated with a dose of 58 mg/kg.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: doses were defined based on a preliminary study (not reported).
0.073, 0.05, 0.041 and 0.035 mL/kg corresponding to 120, 83, 69 and 58 mg/kg, respectively (based on density of 1.65) - Doses:
- 120, 83, and 69 mg/kg for females only
58 mg/kg for both sexes - No. of animals per sex per dose:
- 5 per sex and per group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations of clinical signs and mortality were performed at 30 min, 2, 4 and 6 h on the first day after administration (day 1) and then twice a day up to termination of the observation period. Bodyweight was monitored twice pre-trial (at randomization and on day 1 just before administration) and on days 3, 8 and 14. On day 1, the animals were weighed after a 16-h fasting period.
- Necropsy of survivors performed: yes, on all animals which died during the observation period and on animals killed (fasted overnight) by excision of the femoral arteries, after i.p. overdosage anaesthesia with 5% sodium pentobarbital, at the end of the observation period. Portions of any abnormal entities found in any of the necropsied animals were collected. The tissue samples were fixed and preserved in 10% buffered formalin. Histologic examination was not performed. - Statistics:
- LD50 was calculated by the method of the Probit.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 79.5 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 70.9 - <= 89.2
- Mortality:
- 5/5 female rats at 120 mg/kg, 3/5 females at 83 mg/kg and 1/5 females at 69 mg/kg died before the end of the observation period. The mortalities were observed within 2 h of dosing at 120 mg/kg and during the first week at 83 mg/kg and 69 mg/kg. No deaths occurred in males and females treated at 58 mg/kg (see in Table 1).
- Clinical signs:
- Piloerection, hunched posture and increased salivation were observed in animals treated with the various doses, starting 30 min to 2 h after dosing. For animals treated with the higher doses (83 and 120 mg/kg), sedation or hypoactivity and gasping or shallow breathing were seen starting 30 min (120 mg/kg) or 2 h to day 3 after dosing (83 mg/kg). One rat of the group treated with 69 mg/kg also showed transient shallow breathing.
Recovery was achieved on day 8 for the group treated with 83 mg/kg, on day 2 for the group treated with 69 mg/kg and within 6 h for animals from the group treated with 58 mg/kg. - Body weight:
- Decrease in bodyweight was observed at day 3 in animals treated with 83 mg/kg. Bodyweight gain had returned to normal by day 8. Normal bodyweight growth was found in animals of the lower dose groups.
- Gross pathology:
- In animals which died before the end of the observation period, the main macroscopic findings were erosion and congestion of stomach and congestion, catarrhal content and thinning walls of intestine. In single animals, these changes were accompanied by paleness of liver, spleen, kidneys or heart. In addition, cases of congestion of lungs and kidney medulla were seen. These changes were mainly confined to the animals treated with the highest dose (120 mg/kg).
At the final killing, no appreciable post-mortem changes were noted in animals.
Any other information on results incl. tables
Table 1: Mortality
Doses (mg/kg) |
58 |
69 |
83 |
120 |
Number of treated animals |
10 (males and females) |
5 (females) |
5 (females) |
5 (females) |
Day 1 |
0 |
1 |
0 |
5 |
Day 4 |
0 |
0 |
1 |
0 |
Day 5 |
0 |
0 |
1 |
0 |
Day 7 |
0 |
0 |
1 |
0 |
Total (day 14) |
0 |
1 |
3 |
5 |
Total (%) |
0 |
20 |
60 |
100 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- In conclusion, the LD50 of the test article, when administered to rats as a single dose by oral route, was estimated to be 79.5 mg/kg bodyweight. The compound mainly induced irritation in the gastrointestinal system in the treated rats, especially at the highest dose.
- Executive summary:
The purpose of the study was to evaluate the oral acute toxicity of the test article in Sprague-Dawley Crl: CD(SD) BR rats according to OECD guideline 401 and EU method B.1 and in compliance with good laboratory practices (GLP).
The test item was tested undiluted at the doses of 69, 83 and 120 mg/kg administered by gavage to groups of 5 females per dose and at the dose of 58 mg/kg administered by gavage to 5 males and 5 females. All rats were treated after a 16-h fasting period. The day of treatment was considered as day 1 of the study. Animals were clinically observed for 14 days following the treatment. Moreover, rats were weighed twice before treatment and on days 3, 8 and 14. On day 15, the surviving rats were killed and subjected to a thorough autopsy.
Death occurred in 5/5 female rats at 120 mg/kg, in 3/5 females at 83 mg/kg and in 1/5 females at 69 mg/kg. The mortality occurred within 2 h of dosing at 120 mg/kg and within one week at 83 and 69 mg/kg. No deaths occurred in males and females treated with the dose of 58 mg/kg.
Piloerection, hunched posture and increased salivation were observed in animals treated with the various doses, starting 30 min to 2 h after dosing. For animals treated with the higher doses (83 and 120 mg/kg), sedation or hypoactivity and gasping or shallow breathing were seen starting 30 min (120 mg/kg) or 2 h to day 3 after dosing (83 mg/kg). Recovery was achieved on day 8 for the group treated with 83 mg/kg, on day 2 for the group treated with 69 mg/kg and within 6 h for animals from the group treated with 58 mg/kg.
Decrease in bodyweight was observed at day 3 in animals treated with 83 mg/kg. Bodyweight gain returned to normal by day 8. Normal bodyweight growth was found in animals of the lower dose groups.
In animals which died before the end of the observation period, the main macroscopic findings were erosion and congestion of stomach and congestion, catarrhal content and thinning walls of intestine. In single animals, these changes were accompanied by paleness of liver, spleen, kidneys or heart. In addition, cases of congestion of lungs and kidney medulla were seen. These changes were mainly confined to the animals treated with the highest dose (120 mg/kg).
At the final killing, no appreciable post-mortem changes were noted in animals.
In conclusion, the LD50 of the test article, when administered to rats as a single dose by oral route, was estimated to be 79.5 mg/kg bodyweight. The compound mainly induced irritation in the gastrointestinal system in the treated rats, especially at the highest dose. Therefore, the test substance is classified as Acute Toxicity Category 3 (H301) according to the classification criteria of Regulation (EC) No. 1272/2008 (CLP / EU GHS) and UN GHS.
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.