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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 206-557-8 | CAS number: 354-33-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pentafluoroethane
- EC Number:
- 206-557-8
- EC Name:
- Pentafluoroethane
- Cas Number:
- 354-33-6
- Molecular formula:
- C2HF5
- IUPAC Name:
- 1,1,1,2,2-pentafluoroethane
- Details on test material:
- - Name of test material (as cited in study report): HFC-125
- Physical state: gasseous
- Analytical purity: >99% w/w
- Impurities (identity and concentrations): not reported
- Isomers composition: n/a
- Lot/batch No.: BR 1212
- Expiration date of the lot/batch: 1 year from receipt of the lab
- Stability under test conditions: stable
- Storage condition of test material: Pressurised gas at ambient temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd.
- Age at study initiation: 16-24 weeks old
- Weight at study initiation: 3-4 kg
- Fasting period before study: No
- Housing: 1 animal/cage (about 1 cubic m)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 14/10
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration of the test substance in the exposure chambers was measured hourly during the exposure period by means of GC analysis
- Details on mating procedure:
- mated female rabbits were purchased. No information on the mating procedure is reported
- Duration of treatment / exposure:
- day 6-18 of pregnancy
- Frequency of treatment:
- 6 hrs/day
- Duration of test:
- 29 days (day 0-29 of pregnancy)
- No. of animals per sex per dose:
- 24
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Sex: female
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily during the exposure period
BODY WEIGHT: Yes
- Time schedule for examinations: day 0, 2, 6, 8, 10, 14, 19, 23 and 29
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 29
- Organs examined: reproductive organs
OTHER: - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes / No / No data
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: individual foetal weight - Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [all per litter]
- Skeletal examinations: Yes: [all per litter]
- Head examinations: Yes: [all per litter] - Statistics:
- Analysis of variance followed by Williams' test and Kursal-Wallis test followed by Shirley's test were used to analyse parametric and non-parametric data, respectively. For Litter data and foetal changes the litter was considered the basic sample unit and non-parametric analyses were routinely used. Where 75% or more of the values for a given variable are the same, a Fisher's exact test was used, when considered necessary.
- Indices:
- litter weight
pre-implantation loss
post-implantation loss
sex ratio - Historical control data:
- A group of 9 studies performed in 1991 was used for historical control data in the study report. The historical control database was increased up to
35 studies performed between 1990 and 1993 by HLS in the framework of the OECD SIDS dossier for HFC-125
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
One animal of control group and one of 5000 ppm groups were killed due to poor condition. One animal of control group produced a litter
on day 29 of pregnancy and was excluded from the study. One animal of 5000 ppm group showed weight loss and aborted on days 20/21
of pregnancy. No other instances of abortion were present in the study. Animals showing cold ears during the exposure period was higher in all the treated groups, in comparison with control group. This finding
was considered a response to stress, not directly related to exposure. Statistically significant reduction in food consumption of animals of 50000 ppm-group was observed during the exposure period. However,
no difference in food consumptions was observed between the 5000 and the 15000 ppm groups and the control group, and the effect was
considered no treatment-related. No differences were observed in body weight among the treated and the control groups.
No treatment-related findings were observed at terminal autopsy.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 50 000 ppm
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No treatment-related findings were observed in litter size, embryofoetal loss and litter and foetal weight in the 5000 ppm- and 15000
ppm-groups. A slightly increased incidence of early and late in utero deaths was observed in the 50000 ppm-group, in comparison to control.
However, the in utero loss incidence at 50000 ppm felt within the historical range (originally 9 studies performed on 1991, refined up to 35
studies from the period 1990 -1993) and was not conclusively considered treatment-related.
At lower concentrations there was no related effect on post-implantation losses or litter size. Although the mean incidence of both early and late in utero deaths at 50,000 ppm falls within concurrent background, the total number of in utero deaths at this concentration is slightly greater than
expected (Means reported in Table 1). There were no significant effects on litter weights or mean foetal weights. The incidence of foetal malformations was 2/165, 1/193, 7/215 and 2/169 in control group, 5000, 15000 and 50000 ppm HFC-125, respectively. No statistically significant differences in the incidence of
anomalies and variants were observed during visceral and skeletal examinations of foetuses among the control and the treated groups
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 50 000 ppm
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1: litter data including historical control
|
Litter size |
N. corpora lutea |
Implants |
Pre-implant loss (%) |
Embryonic deaths |
Post-implant loss (%) |
Live young |
||
early |
late |
total |
|||||||
Control |
21 |
11.4 |
8.7 |
22.2 |
0.4 |
0.4 |
0.8 |
9.0 |
7.9 |
5,000 ppm |
21 |
11.2 |
10.2 |
10.9 |
0.6 |
0.4 |
1.0 |
9.9 |
9.2 |
15,000 ppm |
24 |
11.5 |
9.9 |
13.0 |
0.5 |
0.4 |
1.0 |
8.4 |
9.0 |
50,000 ppm |
21 |
11.8 |
9.5 |
18.6 |
0.7 |
0.8 |
1.5 |
15.8 |
8.1 |
Background control range# |
0.4-0.8 |
0.1-0.9 |
0.7-1.4 |
||||||
Extended background control range## |
9.8 (3.6-17.5) |
# from 9 studies perfomed on 1991; ## from 35 studies performed between 1990 and 1993: means of individual study means’ (range of the means)
Applicant's summary and conclusion
- Conclusions:
- HFC-125 did not show adverse effect on reproduction in rabbits exposed up to 50,000 ppm by inhalation
- Executive summary:
Groups 24 mated female rabbits were exposed to 5000, 15000 and 50000 ppm HFC-125 in the day 6-18 of pregnancy for 6 hrs/day.
Animals were housed individually in metal cages and exposed whole body in chambers. HFC-125 concentrations was monitored at 1 hour intervals during the exposure periods.
EXAMINED PARAMETHERS:
Adult females:
All animals were subjected to daily examination for clinical signs of toxicity. Body weight gain and food consumption were measuredregularly during exposure.
On day 20 of pregnancy the animals were killed and examined for pathological changes.
Litter and foetuses:
developmental and teratogenic potential of HFC-125 was assessed by examination of the typical parameters:
-number of corpora lutea
-number and distribution of live young
-number and distribution of embryofoetal deaths
-individual and litter foetal weight
-foetal abnormalities.
Results:
Adult females:
No treatment-related adverse effects were recorded in the study.
Litters:
No treatment-related findings were observed in litter size, embryofoetal loss and litter and foetal weight in the 5000 ppm- and 15000ppm-groups. A slightly increased incidence of early and late in utero deaths was observed in the 50000 ppm-group, in comparison to control.
However, the in utero loss incidence at 50000 ppm felt within the historical range and was not conclusively considered treatment-related.
There were no significant effects on litter weights or mean foetal weights.
No statistically significant differences in the incidence of anomalies and variants were observed during visceral and skeletal examinationsof foetuses among the control and the treated groups.
50,000 ppm was judged as the maternal and foetal NOAEC of the study.
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.