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EC number: 407-420-7 | 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 available data suggest that test substance is non irritant to skin and 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:
- Apr, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted equivalent or similar to EU Method B.4. and OECD Guideline 404 in compliance with GLP
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater Manchester, UK
- Age at study initiation: 15-24 wk
- Weight at study initiation: 3081-4125 g
- Housing: Housed individually in anodised aluminium sheet cages
- Diet (e.g. ad libitum): Labsure CRB Rabbit Diet, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17±2 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance pasted with small amount of deion. water
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 30-60 min, 24, 48 and 72 h after removal of the patches, additional readings were performed after 7 d
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Left flank
- % coverage: 2.5 x2.5 cm
- Type of wrap if used: Yes, The treated areas were covered with pieces of surgical gauze (approximate size 2.5 cm x 2.5cm; 8 ply) each of which was secured by two crossed strips of surgical tape (approximate size 1cm x 8cm). These were covered by a piece of impermeable rubber sheeting (approximate size 35cm x 13cm) wrapped once around the trunk of the animal and secured with adhesive impermeable polyethylene tape (7.5cm wide).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gently cleansed free of any residual test sample using clean swabs of absorbent cotton wool soaked in clean warm water and were then dried gently with clean tissue paper.
- Time after start of exposure: 4 h
SCORING SYSTEM: Erythema, eschar formation and edema were evaluated numerically according to the DRAIZE scale - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed
- Remarks on result:
- other: -
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed
- Remarks on result:
- other: -
- Irritant / corrosive response data:
- - There were no signs of erythema in any animal.
- Very slight oedema was seen in two animals 30-60 min after decontamination. There were no additional signs of irritation. - Other effects:
- None
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance was considered to be non-irritant to rabbit skin following a single 4-h application.
- Executive summary:
A study was conducted to assess the skin irritation potential of test substance to the rabbit skin equivalent or similar to OECD Guideline 404 and EU Method B.4.
A group of three male rabbits each received a single four-hour application of test sample to the shorn flank. The animals were assessed for any signs of skin irritation 30-60 minutes after decontamination and then daily for 3 days.
Very slight oedema was observed in two animals 30-60 minutes after decontamination. There were no further signs of irritation. In conclusion, Substance H112323 was non-irritant to rabbit skin following a single four-hour application.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not 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:
- Apr, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted equivalent or similar to EU Method B.5. and OECD Guideline 405 in compliance with GLP
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater Manchester, UK
- Age at study initiation: 15-24 wk
- Weight at study initiation: 4266-4412 g
- Housing: Housed individually in anodised aluminium sheet cages
- Diet (e.g. ad libitum): Labsure CRB Rabbit Diet, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17±2 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 1-2 h, Day 1, 2 , 3, 4, 6 and 7 of application
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, 24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scale to assess the grade of ocular reaction and A modified form of the Kay and Calandra system was used to interpret and classify the numerical scores. As an aid in the assessment of corneal damage, fluorescein staining was used at the 1, 2 (2 animals), 3, 4, 6 and 7-d readings.
TOOL USED TO ASSESS SCORE: Fluorescein staining - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: Redness could not be fully assessed due to staining of the cornea but is unlikely to have occurred
- Irritant / corrosive response data:
- Application of the test sample into the conjunctival sac of the eye of one rabbit caused moderate initial pain (class 3 on a 0-5 scale). The eyes of the remaining rabbits were treated with a local anaesthetic prior to application and these animals showed no initial pain following application.
Apart from blue staining of the periorbital tissues by the test sample, there were no corneal or iridial effects. Blue staining of the conjunctiva by the test sample obscured any underlying redness which may have been present. However as the conjunctival effects were limited to a severe, but transient, discharge in one animal and an intermittent slight discharge in another animal, it is considered unlikely that significant redness was present in any of the animals. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance was considered to be not irritant to the rabbit eye
- Executive summary:
A study was conducted to assess the eye irritation potential of test substance to the rabbit eye equivalent or similar to EU Method B.5. and OECD Guideline 405 in compliance with GLP.
Instillation of the undiluted test sample into the conjunctival sac of the eye of one rabbit caused moderate initial pain (class 3 on a 0-5 scale). The eyes of the other two rabbits were therefore treated with a local anaesthetic prior to dosing and these animals showed no initial pain following application.
Apart from blue staining of the periorbital tissues by the test sample, there were no corneal or iridial effects. Blue staining of the conjunctiva by the test substance obscured any underlying redness that may have been present. However, as the observed ocular effects were limited to transient/intermittent conjunctival discharge it is considered unlikely that significant conjunctival redness was present in any of the animals.
As the staining is limited to the conjunctiva and no corneal effects occurred It is hence concluded that the test substance has no irritating effects on the rabbit eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin Irritation
A study was conducted to assess the skin irritation potential of test substance to the rabbit skin equivalent or similar to OECD Guideline 404 and EU Method B.4.
A group of three male rabbits each received a single four-hour application of test sample to the shorn flank. The animals were assessed for any signs of skin irritation 30-60 minutes after decontamination and then daily for 3 days.
Very slight oedema was observed in two animals 30-60 minutes after decontamination. There were no further signs of irritation. In conclusion, Substance H112323 was non-irritant to rabbit skin following a single four-hour application.
Eye irritation
A study was conducted to assess the eye irritation potential of test substance to the rabbit eye equivalent or similar to EU Method B.5. and OECD Guideline 405 in compliance with GLP.
Instillation of the undiluted test sample into the conjunctival sac of the eye of one rabbit caused moderate initial pain (class 3 on a 0-5 scale). The eyes of the other two rabbits were therefore treated with a local anaesthetic prior to dosing and these animals showed no initial pain following application.
Apart from blue staining of the periorbital tissues by the test sample, there were no corneal or iridial effects. Blue staining of the conjunctiva by the test substance obscured any underlying redness that may have been present. However, as the observed ocular effects were limited to transient/intermittent conjunctival discharge it is considered unlikely that significant conjunctival redness was present in any of the animals.
As the staining is limited to the conjunctiva and no corneal effects occurred It is hence concluded that the test substance has no irritating effects on the rabbit eye.
Justification for classification or non-classification
Skin
Based on the available in vivo skin irritation study, test substance was found to be non-irritating to skin and does not meet the requirement for classification according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).
Eye
Based on the available in vivo eye irritation study, test substance was found to be non-irritating to the eye and does not meet the requirement for classification according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).
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