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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-831-0 | CAS number: 75-01-4
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, study results also published in peer-reviewed literature, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Embryo-fetal developmental and reproductive toxicology of vinyl chloride in rats.
- Author:
- Thornton, S.R., Schroeder, R.E., Robison, R.L., Rodwell, D.E., Penney, D.A., Nitschke, K.D. and Sherman, W.K.
- Year:
- 2 002
- Bibliographic source:
- Toxicol Sci; 68(1):207-19
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Chloroethylene
- EC Number:
- 200-831-0
- EC Name:
- Chloroethylene
- Cas Number:
- 75-01-4
- Molecular formula:
- C2H3Cl
- IUPAC Name:
- chloroethene
- Details on test material:
- Vinyl chloride was supplied by the Geon Company, Pedricktown, NJ (Lot #1). Purity was > 99.9%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on mating procedure:
- Mating Procedures: One male and one female rat from the same exposure group were co-housed nightly until evidence of mating (microscopic observation of sperm in vaginal smear and/or copulation plug in vagina) or for 14 consectutive days. Unmated females were randomly redistributed to a
sexually active male rat within the same exposure group for an additional 6 days. P2 animals were randomly chosen from a pool of F1 pups (2/litter)
that had been exposed to the same concentration as parents. For the P2 generation, care was taken to avoid brother-sister cohabitations. Once
mated, females were housed individually for the remainder of gestation. - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Females: premating period to gestation day 20, and lactation day 4 until sacrifice. F1 pups selected to become P2 generation were exposed from postnatal day 26 until all litters were weaned. Males (both generations): parallel to females.
- Frequency of treatment:
- 6 hr/d, 5 d/wk during premating; 6 hr/d, 7 d/wk during mating, gestation, lactation, and post-weaning
- Details on study schedule:
- F1 pups selected to become P2 generation were exposed from postnatal day 26 until all litters were weaned.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 100, 1100 ppm
Basis:
- No. of animals per sex per dose:
- Thirty animals/sex/group (for both P1 and P2 generation)
- Control animals:
- yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
No effect of exposure was noted on mortality, physical examination, body weight or body weight gain, food consumption, mating indices, pregnancy rate, male fertility, gestation length, parturition data, or litter size. Effects on organs were limited to liver. Liver weights were significantly increased (by 13-20%) in F0 males exposed to 10, 100 and 1100 ppm and F1 males exposed to 100 and 1100 ppm (Table 1). The relative liver weight in F0 males exposed to 10 ppm was comparable to control F1 male weights and thus was not considered to be VCM-related. Dose-related centrilobular hypertrophy, considered to be a compensatory reaction, occurred in F0 and F1 males exposed to 100 or 1100 ppm and females exposed to 10, 100 or 1100 ppm (Table 2). Increased incidences of altered hepatocellular foci (basophilic, acidophilic and clear well) were observed in livers of F1 males and females exposed to 100 or 1100 ppm.
Effect levels (P0)
- Dose descriptor:
- NOAEC
- Remarks:
- parental
- Effect level:
- 10 ppm
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- other: Generation: F0 and F1 (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Details on results (F1)
No adverse effect of vinyl chloride exposure on pup survival or growth, sex distribution, age for vaginal opening or preputial separation was found. Organ weights were not affected by exposure.
Effect levels (F1)
- Dose descriptor:
- NOAEC
- Remarks:
- offspring
- Generation:
- F1
- Effect level:
- 1 100 ppm
- Basis for effect level:
- other: No effects observed at highest dose level tested
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEC
- Remarks:
- offspring
- Generation:
- F2
- Effect level:
- 1 100 ppm
- Basis for effect level:
- other: No effects observed at highest dose level tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Table
1
Relative
liver weights for the F0 and F1 generation
ppm
VCM
Generation/sex Control
10
100
1100
F0
males 2.83+0.26
3.05+0.29*
3.09+0.20*
3.26+0.19**
F1
males 2.98+0.33
3.01+0.19
3.32+0.36**
3.38+0.19**
F0
females 3.31+0.32
3.34+0.36
3.40+0.30
3.55+0.31
F1
females 3.54+0.66
3.37+0.42
3.60+0.45
3.74+0.38
* p0.05; **
p0.01.
Table
2
Summary
of F0 and F1 generation liver histopathology
ppm
VCM
0
10
100
1100
F0 generation
male rats
centrilobular
hypertrophy 0
0
15
30
acidophilic
foci 0
0
0
1
basophilic
foci 0
0
0
1
female rats
centrilobular hypertrophy 0
2
26
30
F1 generation
male rats
centrilobular
hypertrophy 0
0
19
30
acidophilic
foci 1
0
4
5
basophilic
foci 0
0
0
8
clear
cell foci 0
0
0
5
female rats
centrilobular
hypertrophy 0
6
30
30
acidophilic
foci 0
0
0
8
basophilic
foci 0
0
1
11
N
= 30 for each dose level
Applicant's summary and conclusion
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.