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EC number: 900-600-0 | 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
Endpoint summary
Administrative data
Description of key information
- Skin Corrosion/irritation : irritating based on the rules of the CLP Regulation for classification of mixtures
- Seriou eye damage/eye irritant: Serious eye irritation based on the rules of the CLP Regulation for classification of mixtures
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The study was not carried out according to generally accepted guidelines and the documentation is insufficient for an assessment of the quality of the study.
- Principles of method if other than guideline:
- Dermal application following Draize's method; interpretation of results and scoring following official scoring method for cosmetics
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Female rabbits weighing between 2.4 and 3.0 kg
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- no data
- Duration of treatment / exposure:
- no data
- Observation period:
- no data
- Number of animals:
- six
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: no data
- Score:
- 5.6
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritant / corrosive response data:
- Macroscopic observations included moderate to severe erythema and oedema with some superficial peripheral necrosis.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- It can be concluded that chloroform is irritating to the rabbit's skin.
- Executive summary:
The skin irritation potential of chloroform was tested in female New Zealand rabbits according to the principles of the Draize test. A single application of pure chloroform resulted in moderate to severe erythema and moderate to severe oedema. The primary dermal irritation index of chloroform was 5.6. Chloroform was classified as a severe skin irritant.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Early standard study, very limited documentation, exposure regimen fails to allow interpretation on the basis of current standards (4-h exposure).
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Acc. to Draize (described in Duprat et al., 1974)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Sex: female
- Weight at study initiation: 2.4-3.0 kg - Type of coverage:
- occlusive
- Preparation of test site:
- other: scarified and intact skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- no data
- Number of animals:
- 30 animals
- Details on study design:
- Comparative study including various chlorinated solvents: Dermal application of 0.5 mL under occluded conditions on the scarified and intact skin. Skin was histologically examined on day 3 post-exposure.
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 4.7
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritant / corrosive response data:
- Only overall rating was given (by primary irritation index), but effects specified could not be exactly allocated to the individual test substance. An appraisal was not possible but through comparison relative to the findings on the other substances involved. For example, chloroform and perchloroethylene were graded as "severe" irritants (PI = 5.6 and 6.1, resp., of max. 8 scores), tetrachloromethane was assigned "moderate" (PI = 4.2).
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- A primary irritation index of 4.7 was measured for skin irritation of 1,2-dichloroethane in rabbits. According to CLP Regulation (1272/2008/EC) the substance was classified as irritant (GHS, cat. 2).
- Executive summary:
In a primary dermal irritation study, New Zealand White rabbits (6 females) were dermally exposed to 0.5 mL of undiluted 1,2-dichloroethane for 4 hours. Animals then were observed for at least 3 days. Irritation was scored by the method of Draize. A primary irritation index of 4.7 was measured for skin irritation of 1,2-dichloroethane. According to CLP Regulation (1272/2008/EC) the substance was classified as irritant (GHS, cat. 2).
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A scientifically sound study, but no individual data, limited methodological information.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - application of CTC and other chlorinated solvents to the skin of rabbits
- at day 3 histologic examinations of the treated skin regions
- a non-discribed ranking system for skin lesions (differentiating between erythema and edema) was used to classify the skin lesions macroscopically - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: New Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 2.4 - 3.0 Kg
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light):not reported - Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): very likely 0.5 mL (methods not detailed, only referenced to other publication)
- Concentration (if solution): unclear
- Purity > 99.5 %
VEHICLE
- not reported - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h, observations at 24, 48 and 72 h post treatment
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- other: I.I.C.P (very likely: primary skin irritation index)
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 4.2
- Reversibility:
- fully reversible within: 2 weeks or less
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Interpretation of results:
- other: medium irritating
- Remarks:
- expert judgment
- Conclusions:
- The present publication (Duprat 1976) states CTC to be medium irritating to the skin of rabbits after single application.
- Executive summary:
Individual data from different time points of observation are not presented, so a clear classification according to OECD GHS is not possible.
The publication is a survey report on the irritative potential of different chlorinated solvents. Rabbits were dermaly exposed with CTC (and other solvents) and the skin reaction was observed macroscopically as well as microscopically and scored by an undisclosed scoring system (very likely the Draize score system). Observation periods and dosing also remains unclear.
Referenceopen allclose all
- the authors classify the skin irritation potency of CTC as medium in ranking comprising the stages: non irritating, almost non irritating, medium irritant and severely irritant.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The documentation of the study is insufficient to assess the quality. The results are considered to be not reliable.
- Principles of method if other than guideline:
- according to Draize's test and interpretation according to Kay and Calandra
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- female animals weighing between 2.4 and 3.0 kg
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- no data
- Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- at least two to three weeks
- Number of animals or in vitro replicates:
- six
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: no data
- Score:
- 41
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: One rabbit had ocular lesions after 3 weeks
- Irritation parameter:
- cornea opacity score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- iris score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- conjunctivae score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritant / corrosive response data:
- severe irritation and lesions of the conjunctivae with occurrence of purulent corneal discharge; mydriasis; developing, aggravating keratitis with apparition of translucent zones in the cornea in 4/6 rabbits, with pannus noted in two animals and hypopyon noted in one animal; recovery from these ocular effects took 2 to 3 weeks for most animals, except for one animal which still had corneal opacity after 3 weeks
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Chloroform is irritating to the eyes.
- Executive summary:
An eye irritation test with chloroform was performed according to Draize's method with six female New Zealand rabbits. Instillation of pure, liquid chloroform led to severe irritation and lesions of the conjunctivae with occurrence of purulent corneal discharge. Other effects included corneal inflammation. Recovery from these ocular effects took 2 to 3 weeks for most animals, except for one animal which still had corneal opacity after 3 weeks. According to the scoring system of Kay and Calandra, chloroform was considered to be highly irritating to the rabbit's eye.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, limited documentation.
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Draize Test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Sex: female
- Weight at study initiation: 2.4-3.0 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
amount applied: 0.1 mL - Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- Eyes were not rinsed.
Comparative study including various chlorinated solvents, 6 animals used per test. For evaluation of irritating effects, a primary irritation index was derived by means of the "Draize Score" on a scale from 0-110 scores. The range of categorisation for "mild" irritant was given as 4- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: not indicated
- Score:
- 7
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: total observation time: 14 days
- Irritation parameter:
- cornea opacity score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- iris score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- conjunctivae score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritant / corrosive response data:
- After instillation of 0.1 mL of 1,2-dichloroethane into the conjunctival sac, moderate lacrimation, mild-moderate catarrhal conjunctivitis and corneal epithelium abrasion were visible in the slit lamp using fluorescein. On day 7 after instillation, keratitis was still evident, but regenerating, and fully disappeared after another 7 days. The effects were graded as "mild" with an overall irritation index of 7 (of 110 scores). [note: Chloroform reached an index of 41 (of 110 scores).]
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Eye irritation test with 1,2-dichloroethane in female rabbits. The effects were graded as "mild" with an overall irritation index of 7 (of max. 110 scores).
- Executive summary:
In a primary eye irritation study, 0.1 mL of undiluted 1,2-dichloroethane was instilled into the conjunctival sac of new Zealand rabbits (6 females). Eyes were not rinsed. Animals then were observed for 14 days. Irritation was scored by the method of Draize. After instillation, moderate lacrimation, mild-moderate catarrhal conjunctivitis and corneal epithelium abrasion were visible in the slit lamp using fluorescein. On day 7 after instillation, keratitis was still evident, but regenerating, and fully disappeared after another 7 days. The reversible effects were graded as "mild" with an overall irritation index of 7 (of max. 110 scores).
1,2 -dichloroethane was a mild eye irritant in rabbits under the conditions of this study.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically sound study, but no individual data, limited methodological information
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The system of eye irritation scoring by Kay and Calandra (John H. Kay , Joseph C. Calandra , Interpretation of eye irritation tests (1962), Journal of Cosmetic Science, Vol. 13, No. 6, pp. 281-290) was used to classify the skin lesions macroscopically
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: New Zealand
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 2.4 - 3.0 Kg
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light):not reported - Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100 %
VEHICLE
- not applicable - Duration of treatment / exposure:
- single application, no wash out
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
SCORING SYSTEM: Draize Scoring (see "Any other information on materials and Methods")
TOOL USED TO ASSESS SCORE: not reported - Irritation parameter:
- other: irritation score as defined by Kay and Calandra (1962)
- Basis:
- mean
- Time point:
- other: unclear
- Score:
- 5
- Reversibility:
- fully reversible within: 2 weeks
- Irritation parameter:
- cornea opacity score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- iris score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- conjunctivae score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Interpretation of results:
- other: slightly irritating
- Remarks:
- expert judgment
- Conclusions:
- The present publication (Duprat 1976) states CTC to be minimally irritating to the eye of rabbits after single application.
- Executive summary:
The publication is a survey report on the irritative potential of different chlorinated solvents. Rabbits were ocular exposed with CTC (and other solvents) and the reaction of the eye was observed macroscopically as well as microscopically and scored by the scoring system of Kay and Calandra (1962). Individual data from different time points of observation are not presented. The effects are reported to be reversible within 1 to 2 weeks.
Referenceopen allclose all
- according to Kay and Calandra (1962) a score of 5 is equivalent with minimally irritating
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
SKIN IRRITATION
Carbon tetrachloride:
In an old skin irritation study performed similarly to the Draize test, slight to moderate irritating potential was observed for CTC (Duprat, 1976). In another hand, a skin sensitization test (LLNA) recently performed (Rokh, 2010), CTC did not induce any local reaction at the highest tested concentration (100%). Therefore, it is considered as non-irritant.
Chloroform and Dichloroethane:
These constituents were also tested for skin irritation by Duprat in 1976. In the studies, moderate to severe irritation reactions were observed. Chloroform and dichloroethane are therefore considered to be skin irritants.
EYE IRRITATION:
Carbon tetrachloride:
Mild irritation reaction of the rabbit eye after treatment with CTC were reported in an old eye irritation study, but the data and the information on methods (including doses) are very limited. A recovery period of 1 to 2 weeks was reported in this study. Therefore the substance is not considered to be an eye irritant.
Chloroform and Dichloroethane:
The constituents were also tested for eye irritation by Duprat in 1976. In these studies, moderate to severe irritation and lesions were observed. Chloroform and dichloroethane are therefore considered to be eye irritants.
RESPIRATORY IRRITATION:
Based on the effects observed in inhalation studies performed on chloroform and dichloroethane, these constituents are considered to be irritating to the respiratory tract.
CONCLUSION:
The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria was used to determine the skin and eye irritating potential of the registered substance.
The registered substance has not been tested itself in appropriate in vitro or in vivo tests but some of its constituents are classified as skin irritant Cat.2 and eye irritant Cat.2 and are present above the CLP generic concentration limit of 10 and 3% for skin and eye irritation, respectively, that triggers classification of the mixture. Moreover, 1,2 -dichloroethane is also classified as respiratory irritant STOT-SE 3 and is above the generic concentration limit of 20%.
Therefore, the registered substance is a skin, eye and respiratory tract irritant.
Justification for classification or non-classification
Harmonized classification:
The registered substance has no harmonized classification according to the Regulation (EC) No.1272/2008 (CLP).
Self-classification:
Based on the available information and typical composition, the registered substance is classified as skin irritant: Skin Irritant Category 2 (H315: Causes skin irritation), Eye irritant Category 2 (H319: Causes serious eye irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Regarding respiratory irritation, the criteria for classification as STOT-SE 3 (H335: may cause respiratory irritation) are met but this classification is deemed unnecessary because more severe organ effects including in the respiratory system are observed in the Acute Toxicity study by inhalation, and is considered covered by the ATI Cat.3 (H331).
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.