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EC number: 436-010-0 | CAS number: 422278-61-3 PRIMID V40-32
- 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
In vivo OECD TG 404 study on rabbits: not irritating to skin
In vivo OECD TG 405 study on rabbits: not irritating to 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:
- From June 05th to July 24th, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne/France
- Age at study initiation: 12-13 weeks for males, 10-11 weeks for females
- Weight at study initiation: 2.3-2.4 Kg
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with autoclave wood and haysticks for gnawing
- Diet (e.g. ad libitum): Pelleted standard Kliba 3418, batch no. 90/01 rabbit maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum.
- Water (e.g. ad libitum): Community tap water available ad libitum.
- Acclimation: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- bi-distilled
- Controls:
- no
- Amount / concentration applied:
- 0,5 g of substance per animal, diluted in bi-distilled water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 per test (both sexes)
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm2
- Type of wrap if used: surgical gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: individual mean score for erythema/eschar and oedema - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h after removal
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h after removal
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h after removal
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h after removal
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h after removal
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h after removal
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h after removal
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h after removal
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The test item did not elicit any skin reactions at the application site of any animal at any of the observation times. The individual mean score for erythema/escar and oedema for each of the three animals was therefore 0.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin - Other effects:
- No clinical signs of systemic toxicity and no mortality occured. No staining by the test item of the treated skin was observed. The body weights of alla rabbits were considered to be within the noraml range of variability.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Substance did not induce any reaction in rabbit skin. All erythema and oedema scores were 0. Therefore the substance can be considered as not irritating to skin
- Executive summary:
The primary skin irritation potential of the substacne was investigated by topical semi-occlusive application of 0,5 g to 6 cm2 intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment ws four hours. The scoring of skin reactions was performed 1,24,48 and 72 hours after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times. The individual mean score for erythema/escar and oedema for each of the three animals was therefore 0. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Therefore the substance can be considered as not irritating to skin.
Reference
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:
- From July 3th to July 19th, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne/France
- Age at study initiation: 10-11 weeks (both sexes)
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with autoclave wood and haysticks for gnawing
- Diet (e.g. ad libitum): Pelleted standard Kliba 3418, batch no. 90/01 rabbit maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum.
- Water (e.g. ad libitum): Community tap water available ad libitum.
- Acclimation: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0,1 g/animal
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 3 per test (1 male, 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Substance was not removed.
SCORING SYSTEM: Cumulative Scores for the Eye Irritation Scores, including corneal opacity, iridic effects, conjunctival reddening and/or chemosis. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of weak irritation
- Remarks:
- One rabbit showed reversible irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.89
- Max. score:
- 6
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- Eye reactions (mean values from 24 to 72 hours) consisted of grade 0.33 corneal opacity, grade 0.00 iris lesions, grade 2.00 redness of the conjunctivae and grade 0.56 chemosis of the conjunctivae. A slight corneal opacity was observed in one fenale from 24 to 72 hours after treatment.
Slight to moderate reddening of the conjunctivae was observed in the male from 1 hour to 7 days after treatment. Slight to marked reddening was also noted in both females from 1 to 72 hours after treatment.
Slight swelling of the conjunctivae was evident in male at the 1 and 24 hours readings. Slight to obvious swelling (with partial eversion of lids) was observed in both females from either 1 to 24 hours after treatment.
A slight to moderate mucus discharge was observed in both females at the 1, 24 and 48 hours readings.
Moderate reddening of the sclera was noted in the male from 1 to 24 hours after treatment. Slight to moderate reddening was observed in both females during the observation period but cleared by day 7.
No corrosion of the cornea was observed at any of the reading times. - Other effects:
- No abnormal findings were noted in the treated eye of any animal on test day 10 at termination. No staining of the treated eyes by the test itme was observed. The body weights were considered to be within the normal range of variability.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Although the substance showed some effects on eyes of rabbits, except for the conjunctivae redness grade which anyhow resulted at the lower level for classification, all the other parameters measured in the study are well below the limit of classification not showing any effect of the chemical on the eye.
As the substance is a powder and was applied as such (undiluted) to the eyes, the redness effect on conjunctivae is probably due to the physical effect of the powder and not to the chemical nature of the substance and as a consequence the substance is not considered as irritant to eyes.
- Executive summary:
An in vivo study on rabbits was performed according to OECD TG 405. A dose of 0.1 g of the substance was instillated into one eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48, 72 hours, 7 and 10 days after application. The scores at reading times 24, 48 and 72 hours were used in calculating the respective mean values for each type of lesion.
No effects on iris were noted in any animal at any reading time.
The substance induced corneal opacity in one female, with mean score of 1 (mean of three animals 0.33), and conjunctival chemosis in all three rabbits, with total mean scores of 0.56 (0.33 and 1 for the two females, 0.33 for the male).
The most relevant effect was conjunctival redness, with mean score of 2 and 2.33 in females, and 1.67 on male.
The overall irritation score, calculated as the mean cumulative scores of all effects at 24, 48 and 72 hours, was determined to be 2.89.
All effects were reversible within 10 days.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No effects on rabbit's skin were induced by the substance in a valid and reliable in vivo study on rabbits (OECD 404). All erythema and oedema scores were 0. Therefore, the substance is not classified for skin irritation according to CLP criteria.
Although the substance showed some effects on eyes of rabbits in a valid in vivo study according to OECD TG 405,
except for the conjunctivae redness grade which anyhow resulted at the lower level for classification, all the other parameters measured in the study are well below the limit of classification not showing any effect of the chemical on the eye.
As the substance is a powder and was applied as such (undiluted) to the eyes, the redness effect on conjunctivae is probably due to the physical effect of the powder and not to the chemical nature of the substance and as a consequence the substance is not considered as irritant to eyes.
No study is available regarding respiratory irritation, therefore no conclusion on classification can be done.
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