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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 279-242-6 | CAS number: 79720-19-7
- 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
The substance is corrosive and causes severe damage of the skin already 3 minutes after application and severe damage to the eyes.
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:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: small white Russian, Chbb-SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1 - 2.4 kg
- Housing:individually in stainless stell cages
- Diet (e.g. ad libitum): K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, Soest, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-1 °C
- Humidity (%): 60+/-5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 31.07. To: 06.08.1984 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml of the test product to approx. 6 cm² skin area.
- Duration of treatment / exposure:
- Skin reaction was assessed and recorded at 1 and 24 h after removal of the dressing and after 48 h and 72 h and after 6 days.
- Observation period:
- 6 days
- Number of animals:
- 3 males, 3 females
- Irritation parameter:
- erythema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: area of application grey-white, edges of the area of application dark red; area of application with yellow-brown spots (2 animals); area of application with red-brown spots (1 animal)
- Irritation parameter:
- erythema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: area of application grey-white, edges of the area of application dark red; area of application with red-brown spots; induration of the area of application
- Irritation parameter:
- erythema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: induration of the area of application; severe necrosis with vesiculation over the entire area of application; edges of the area of application dark red (1 animal)
- Irritation parameter:
- erythema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- other: 6 days
- Reversibility:
- not specified
- Remarks on result:
- other: severe necrosis with vesiculation over the entire area of application
- Irritation parameter:
- erythema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: area of application grey-white, edges of the area of application dark red; area of application with yellow-brown spots (2 animals); area of application with red-brown spots (1 animal)
- Irritation parameter:
- erythema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: area of application grey-white, edges of the area of application dark red; area of application with red-brown spots; induration of the area of application
- Irritation parameter:
- erythema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: edges of the area of application dark red (2 animals); induration of the area of application; severe necrosis with vesiculation over the entire area of application
- Irritation parameter:
- erythema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- other: 6 days
- Reversibility:
- not specified
- Remarks on result:
- other: severe necrosis with vesiculation over the entire area of application
- Irritation parameter:
- edema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- other: 6 days
- Reversibility:
- not specified
- Remarks on result:
- other: open weeping wounds, bleeding cracks
- Irritation parameter:
- edema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- other: 6 days
- Reversibility:
- not specified
- Remarks on result:
- other: open weeping wounds, bleeding cracks
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- The substance is skin corrosive.
- Executive summary:
The substance is skin corrosive.
Reference
After 6 days, the experiment was terminated due to severe effects.
The irritation index was 6.13/8 and hence a single dermal application of 0.5 ml of the product is very irritant for male and female rabbits.
Evaluation in accordance with Appendix VI of the Sixth Amendment (79/831/EEC):
Erythema: x = 4.0
Oedema: x = 2.78
There was necrosis formation after an exposure time of only 3 minutes.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: small white Russian, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): K4 Alleinfutter für Kaninchen, Ssniff Spezialfutter GmbH, Soest, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 31.07. To: 06.08.1984 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml of the product
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- Time of assessment: 1 h, 24 h, 48 h, 72 h, 6 days
- Number of animals or in vitro replicates:
- 3 males, 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24 h with warm physiological solution
SCORING SYSTEM: according to Draize scale
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 20
- Max. score:
- 20
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 36.67
- Max. score:
- 40
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 40
- Max. score:
- 60
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 50
- Max. score:
- 60
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 6 days
- Score:
- 51.67
- Max. score:
- 60
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- other: The iris could not be assessed because of the severe chemosis. Since all the animals showed damage to the iris after chemosis had disappeared, the iris is assessed at "1" at and after the first hour.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- other: redness of the iris (1 animal)
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- other: redness of the iris (3 animals)
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- other: redness of the iris (3 animals)
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 6 days
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- other: redness of the iris (2 animals), circumcorneal injection (2 animals)
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 18
- Max. score:
- 18
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 19.33
- Max. score:
- 20
- Reversibility:
- not specified
- Remarks on result:
- other: Eye glued shut, formation of heavy white secretion; Corrosion of the mucosa, dissolution
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 18.67
- Max. score:
- 20
- Reversibility:
- not specified
- Remarks on result:
- other: Eye glued shut, formation of heavy white secretion; Mucosal haemorrhage in parts; Corrosion of the mucosa, dissolution
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 17.67
- Max. score:
- 18
- Reversibility:
- not specified
- Remarks on result:
- other: Eye glued shut, formation of heavy white secretion; Mucosal haemorrhage in parts; Corrosion of the mucosa, dissolution (2 animals)
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.8
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 3.2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- The substance has an irritation index of 60.25/110 and thus must be denoted as being very irritant for the eyes and the mucosa of the eye.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance causes irreversible effects on the eyes.
- Executive summary:
The substance has an irritation index of 60.25/110 and thus must be denoted as being very irritant for the eyes and the mucosa of the eye.
Mean scores for cornea, iris, conjunctiva redness and chemosis for all 6 animals after 24, 48, and 72 hours were 2.11, 1.0, 2,89, and 3.5, however reading of the eyes was not possible to all time points due to severe chemosis and bleeding of the conjunctivae, which partially peeled off.
Reference
All the animals held their heads on one side up to 48 h after application (in each case toward the treated side). Because of the severity of the damage, the investigation was terminated after the 5th assessment, and the animals were sacrificed.
Mean scores for cornea, iris, conjunctiva redness and chemosis for all 6 animals after 24, 48, and 72 hours were 2.11, 1.0, 2,89, and 3.5, however reading of the eyes was not possible to all time points due to severe chemosis and bleeding of the conjunctivae, which partially peeled off.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There is one reliable study on the skin irritancy potential. Skin irritation was tested in a guideline study according to OECD guideline 404 in 6 small white Russian, Chbb-SPF rabbits.
With reference to the reported scores and the severity of effects the test item has to be classified as corrosive according (H 314 causes severe skin burns and eye damage) to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC). As necrosis was already obvious after 3 min of exposure a classification as Cat. 1A is recommended.
There is one reliable study available on the eye irritancy potential. The test item was tested for its eye irritant properties in 6 small white Russian rabbits (3males and 3 females). Because of the severity of the damage, the investigation was terminated after the 5th assessment (6 days after end of exposure), and the animals were sacrificed. Mean scores for cornea, iris, conjunctiva redness and chemosis for all 6 animals after 24, 48, and 72 hours were 2.11, 1.0, 2,89, and 3.5, however reading of the eyes was not possible to all time points due to severe chemosis and bleeding of the conjunctivae, which partially peeled off.
With reference to the reported scores and severity of effects the test substance has to be classified as severely irritant to the eyes (H 318 causes serious eye damage) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Justification for classification or non-classification
With reference to the reported scores and the severity of effects the test item has to be classified as skin corrosive Cat. 1A and as causing serious eye damage (H 314 causes severe skin burns and eye damage) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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.