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EC number: - | 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
The key study for skin irritation, conducted according to OECD Test Guideline 404 and in compliance with GLP, reported elicited well-defined, persistent dermal irritation in rabbits; although, the irritancy score did not meet the criteria for irritation. However, desquamation evident in two test animals at study termination on Day 14 indicates that classification as Skin Irritant Category 2 is appropriate (Dow Corning Corporation, 2000c).
In the key study for eye irritation, conducted according to OECD Test Guideline 405 and in compliance with GLP, corneal lesions, iridial and conjunctival inflammation were evident. All animals were sacrificed on humane grounds (Dow Corning Corporation, 2000d).
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:
- June to April 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Information removed from report
- Age at study initiation: minimum 12 weeks
- Weight at study initiation: 2489 to 2671 g
- Housing: Individually housed in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 -23
- Humidity (%): 33-56
- Air changes (per hr):minimum 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- Single dose, 4 hour exposure
- Observation period:
- The treated skin was examined on Day 1 and on days 2, 3 and 4 (24, 48 and 72 hours after removal of the dressings) and additional observations made on days 5 through 14 for all animals.
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: dorso lumbar region
- % coverage: 10
- Type of wrap if used: porous gauze pad was covered with semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The single application of test material elicited a persistent well-defined dermal irritation in all animals with resolution complete by Day 14. The irritant response was associated with desquamation of the stratum corneum (characterised with dryness and sloughing) notable in all animals with skin thickening in two animals during the observation period with desquamation still evident at study termination. The primary irritation index was calculated to be 4.1.
- Other effects:
- No deaths occurred during the study. There was no evidence of systemic toxicity to treatment.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In the skin irritation study, conducted according to OECD 404 and in compliance with GLP, the test material elicited well-defined persistent dermal irritation in rabbits; although, the irritancy score did not meet the criteria for irritation. However, desquamation evident in two test animals at study termination on Day 14 indicates that the test material is a skin irritant (Category 2).
Reference
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:
- key study
- Study period:
- June - September 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Information removed from study report
- Age at study initiation: 13 weeks
- Weight at study initiation: 2678 to 2841 g
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 33 to 53
- Air changes (per hr): ca. 18
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 14 day observation period
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM: Draize, 1959
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- other: experiment terminated early due to animal welfare considerations
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- other: experiment terminated early due to animal welfare considerations
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: experiment terminated early due to animal welfare considerations
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- other: experiment terminated early due to animal welfare considerations
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Unable to assess reaction due to excessive swelling
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Unable to assess reaction due to excessive swelling
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: experiment terminated early due to animal welfare considerations
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- other: experiment terminated early due to animal welfare considerations
- Irritant / corrosive response data:
- The test material elicited primarily conjunctival irritation in the pilot animal, although Grade 1 corneal opacity was also evident 48 and 72 hours after instillation. Two more animals were treated based on the findings in the first animal. Corneal lesions, iridial and conjunctival inflammation quickly exceeded that previously observed in the pilot animal and within 48 hours the animals were sacrificed on humane grounds. Due to the severity of these ocular lesions in the two animals, it was not possible to determine their reversibility.
- Other effects:
- There was no evidence of systemic toxicity to treatment.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In the key study for eye irritation, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test material is concluded to be corrosive, based on corneal lesions, and thereafter iridial and conjunctival inflammation. The animals were sacrificed on humane grounds within 48 hours and therefore, it was not possible to determine the reversibility of the effect.
Reference
Under the conditions of this study the test material elicited corneal opacification, iridial inflammation and well-defined conjunctival irritation and is considered an eye irritant with the potential to cause serious damage to the eyes.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key study for skin irritation was conducted according to a relevant guideline and in compliance with GLP. The single application of test material elicited persistent well-defined dermal irritation in all animals with resolution complete by Day 14. The irritant response was associated with desquamation of the stratum corneum notable in all animals with skin thickening in two animals during the observation period with desquamation still evident at study termination. No deaths occurred during the study. There was no evidence of systemic toxicity to treatment. Despite the well-defined persistent dermal irritation reported in the study, the irritancy score did not meet the criteria for irritation. However, desquamation evident in two test animals at study termination on Day 14 indicates the test substance causes skin irritation (Category 2) (Dow Corning Corporation, 2000c).
In the key study for eye irritation, conducted according to OECD Test Guideline 405 and in compliance with GLP,
the test material elicited primarily conjunctival irritation in the pilot animal, with Grade 1 corneal opacity being evident at 48 and 72 hours after instillation. Two more animals were treated based on the findings in the first animal. Corneal lesions, iridial and conjunctival inflammation quickly exceeded the previously observed effect in the pilot animal. Due to the severity of these ocular lesions in the two further animals, the animals were sacrificed on humane grounds within 48 hours and it was not possible to determine the reversibility of the effect. No evidence of systemic toxicity following treatment of the test material was observed (Dow Corning Corporation, 2000d).
Justification for classification or non-classification
Based on the available in vivo data, the registered substance is classified for skin irritation, Category 2: Irritant, H315: causes skin irritation and Irreversible effects on the eye, Category 1, H318: Causes serious eye damage, in accordance with Regulation (EC) No. 1272/2008.
The registered substance may contain acetic anhydride (CAS 108-24-7) at concentrations <10% w/w. In accordance with the harmonised entry in Annex VI of Regulation (EC) No 1272/2008 (specific concentration limits), acetic anhydride concentrations ≥5% should carry the additional classification STOT SE 3; H335: May cause respiratory irritation. In the absence of measured data for the inhalation route to override this limit, the additional classification is applied to the registration substance.
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.
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