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EC number: 204-825-9 | CAS number: 127-18-4
- 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP status not reported, available as unpublished report, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Tetrachloroethylene
- EC Number:
- 204-825-9
- EC Name:
- Tetrachloroethylene
- Cas Number:
- 127-18-4
- Molecular formula:
- C2Cl4
- IUPAC Name:
- tetrachloroethene
- Details on test material:
- - Name of test material (as cited in study report): tetrachloroethylene- Analytical purity: > 99.95%- Composition of test material, percentage of components: stabilized with ionol (10 mg/l)- Storage condition of test material: packed in dark coloured glass bottles and stored at room temperature until use. - Other: Due to the low levels of stabilizer added to the solvents degradation may occur in contact with light metals, especially aluminium. Contact of the test material with metals was prevented at all times, before and during the experiments.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: ENKI-Konijnenfarm, Someren, The Netherlands- Weight at study initiation: 2.5 - 3.0 kg- Housing: individually, suspended, galvanized cages, fitted with a wire-mesh floor and front. - Diet: ad libitum- Water: ad libitum- Acclimatization period: 6 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 +/- 3- Humidity (%): >40- Air changes (per hr): 10 - Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: stabilized with ionol
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 ml- Concentration (if solution): 10 mg/l
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- at 1, 24, 48, 72 hours, 9 and 16 days after the 4 hour expsoure period
- Number of animals:
- Experiment 1 (tetrachloroethylene tested individually): 3Experiment 2 (tetrachloroethylene examined simultaneously with three other solvents on separate skin areas): 3
- Details on study design:
- TEST SITE- Area of exposure: 1 inch x 1 inch- Type of wrap if used: patches fixed to the application sites by means of adhesive tape and the entire trunk of each rabbit was wrapped with an impervious material. REMOVAL OF TEST SUBSTANCE- Washing (if done): with lukewarm water and soap- Time after start of exposure: 4 hoursSCORING SYSTEM:Method of Draize et al. (1944)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours after the application
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: at day 16, the mean score was 1.3
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours, 9 and 16 days after the application
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- other: at day 16, the mean score was 0.7
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other: The primary Irritation Index was calculated by combining the scores for erythema/eschar formation and oedema
- Time point:
- other: 24, 48 and 72 hours after application
- Score:
- 5.7
- Remarks on result:
- other: Experiment 1 (tetrachloroethylene tested individually): 3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours after the application
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: at day 16, the mean score was 0.7. After five weeks all effects had cleared completely.
- Remarks on result:
- other: tetrachloroethylene examined simultaneously with three other solvents on separate skin areas
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours, 9 and 16 days after the application
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- other: at day 16, the mean score was 0.3. After five weeks all effects had cleared completely.
- Remarks on result:
- other: tetrachloroethylene examined simultaneously with three other solvents on separate skin areas
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other: The primary Irritation Index was calculated by combining the scores for erythema/eschar formation and oedema
- Time point:
- other: 24, 48 and 72 hours after application
- Score:
- 5.9
- Remarks on result:
- other: Experiment 2 tetrachloroethylene examined simultaneously with three other solvents on separate skin areas
- Irritant / corrosive response data:
- Experiment 1:Generally the following skin reactions were observed at one or more observation time points, up to 72 hours after treatment: well-defined erythema, very slight or slight oedema, very slight ischemic necrosis (not after 4 hours) and very slight incrustation (after 72 hours only).After 9 days well-defined erythema, very slight oedema and moderate scaliness (in all three rabbits) and very slight incrustation (in two rabbits) were reported.After 16 days very slight or well-defined erythema (in all three rabbits) and slight oedema (in one rabbit) were observed.Experiment 2:Generally the following skin reactions were observed at one or more observation time points, up to 72 hours after treatment: well-defined or moderate erythema, very slight or slight oedema, very slight ischemic necrosis (not after 4 hours) and slight scaliness or slight incrustation (mainly after 72 hours).After 9 days well-defined erythema, very slight or slight oedema (in all three rabbits), slight or severe scaliness (in two rabbits) and moderate incrustation (in one rabbit) were reported.After 16 days very slight or well-defined erythema (in all three rabbits), very slight oedema (in two rabbits) and decreased hair growth (in one rabbit) were observed.After five weeks all effects had cleared completely.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- According to CLP criteria (mean value of ≥2,3 - ≤4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal) the substance shall be classified as Skin Irrit. Category 2, H315: causes skin irritation.
- Executive summary:
A skin irritation in rabbits is avaialble according to OECD guideline No. 404 and conducted under GLP (Van Beek, 1990). Two groups of 3 New Zealand White rabbits were treated with a substance of > 99.95 % purity stabilized with ionol (concentration 10 mg/l). 0.5 ml of the test material was applied as an occlusive coverage on a shaved skin for 4 hours. After exposure the test material was washed up with a warm water and soap. Skin reactions were scored by the method of Draize (1944) at 1, 24, 48, 72 hours, 9 and 16 days after the exposure. Well-defined erythema was observed 24, 48, 72 hours after the application (mean score “4”) which was not fully reversed at day 16. Other skin reactions (oedema – mean score 1.7-1.9, ischemic necrosis, incrustation, scaliness) were from slight to moderate at different time points. According to CLP criteria (mean value of ≥2,3 - ≤4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal) the substance shall be classified as Skin Irrit. Category 2, H315: causes skin irritation.
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