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EC number: 263-417-9 | CAS number: 62121-75-9
- 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
Both skin and eye irritation assessments are based on studies performed with rabbits (in vivo) according to FDA guidelines (patch test and mucuous membrane test). No irritating effect that would be relevant for a classification was observed in any of the test systems. Both test systems include 1 treatment with the pure substance, an exposure time of 24 h and an observation time until 72 h after application. The test item was found to have no adverse effects (not irritating).
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
- Study period:
- 1977-05-09 to 1977-05-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Patch Test
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- - Test animal weight: 1.5 - 2.0 kg
- One cage per animal
- Feeding: standard food ERKA 8300, ad libitum
- Water: tap drinking water, ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg powder - Duration of treatment / exposure:
- 1 treatment at 0 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- Type of wrap if used: gaze and PVC sheet (coverage)
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
OBSERVATION TIME POINTS: 24 h, 48 h, 72 h
SCORING SYSTEM:
- Method of calculation: erythema (scoring 0-4) and oedema (scoring 0-4)
- The erythema and oedema scores were calculated for each individual animal after 25 and 72 h. The sum of the scores for all rabbits was divided by 6 (number of test animals) and then by 4 (scoring). The classification is: 0.0 - 0.5: non irritant, 0.6 - 3.0: slightly irritant, 3.1 - 5.0 (moderately irritant), 5.1 - 8.0: severely irritant - Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- based on erythema and oedema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation observed.
- Other effects:
- - Other adverse local effects: none
- Other adverse systemic effects: none - Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritation (erythema and oedema scoring) was observed at 24h, 48h and 72h after a 24h patch exposure with the pure substance on rabbits. Therefore, the substance is not considered to be irritating to skin according to CLP criteria.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1979-10-29 to 1979-11-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Patch Test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- - Test animal weight: 1.5 - 2.0 kg
- One cage per animal
- Feeding: standard food ERKA 8300, ad libitum
- Water: tap drinking water, ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL pure substance (liquid) - Duration of treatment / exposure:
- 1 treatment at 0 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- Type of wrap if used: gaze and PVC sheet (coverage)
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
OBSERVATION TIME POINTS: 24 h, 48 h, 72 h
SCORING SYSTEM:
- Method of calculation: erythema (scoring 0-4) and oedema (scoring 0-4)
- The erythema and oedema scores were calculated for each individual animal after 25 and 72 h. The sum of the scores for all rabbits was divided by 6 (number of test animals) and then by 4 (scoring). The classification is: 0.0 - 0.5: non irritant, 0.6 - 3.0: slightly irritant, 3.1 - 5.0 (moderately irritant), 5.1 - 8.0: severely irritant - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h (last time-point observed)
- Remarks on result:
- no indication of irritation
- Remarks:
- 1 out of 6 rabbits still showed minimal reddening at 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.056
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight initial irritation observed.
- Other effects:
- - Other adverse local effects: none
- Other adverse systemic effects: none - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Very slight irritation (erythema and oedema scoring) was observed at 24h, 48h and 72h after a 24h patch exposure with the pure substance on rabbits. Therefore, the substance is not considered to be irritating to skin according to CLP criteria.
Referenceopen allclose all
Endpoint |
24 h |
48 h |
72 h |
|
Scarified skin sum of 6 animals |
Erythema |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
|
Intact skin sum of 6 animals |
Erythema |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
|
Sum |
0 |
0 |
0 |
Endpoint |
24 h |
48 h |
72 h |
|
Scarified skin sum of 6 animals |
Erythema |
6 |
3 |
1 |
Oedema |
0 |
0 |
0 |
|
Intact skin sum of 6 animals |
Erythema |
6 |
3 |
1 |
Oedema |
1 |
0 |
0 |
|
Sum |
13 |
6 |
2 |
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:
- weight of evidence
- Study period:
- 1979-10-29 to 1979-11-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Mucuous Membrane Test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- - Test animal weight: 1.5 - 2.0 kg
- One cage per animal
- Feeding: standard food ERKA 8300, ad libitum
- Water: tap drinking water, ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of pure substance (liquid) - Duration of treatment / exposure:
- 1 treatment at 0 h
- Observation period (in vivo):
- 72 h
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h after treatment
SCORING SYSTEM:
- cornea: opacity (0 - 4) and effected area (0 - 4)
- iris: viability (0 - 4)
- conjunctiva: erythema (0 - 4), swell (0 - 4), secretion (0 - 4)
0 is no effect, 4 is a severe effect. The sum of all values from cornea, iris and conjunctiva is multiplied by 2. The mean value for all animals is divided by the number of animals (6). The score is determined at all points of observation (1, 7, 24, 48, 72 h after treatment). The highest score at any point of time is used for the assessment (worst case).
Overall scoring: 0 - 10: non irritant, 11 - 25: slightly irritant, 26 - 56: moderately irritant, 57 - 110: severely irritant
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 1
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Minimal reddening was observed in some animals up to 48 hours. One rabbit showed minimal chemosis at 1 and 7 hours after test substance application. No signs of irritation were observed.
- Other effects:
- None.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No irritation (overall scoring) was observed after a 24h exposure with the pure substance on rabbits. Therefore, the substance is not considered to be irritating to eyes according to CLP criteria.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1977-05-09 to 1977-05-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Mucuous Membrane Test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- - Test animal weight: 1.5 - 2.0 kg
- One cage per animal
- Feeding: standard food ERKA 8300, ad libitum
- Water: tap drinking water, ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of pure substance (powder) - Duration of treatment / exposure:
- 1 treatment at 0 h
- Observation period (in vivo):
- 72 h
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h after treatment
SCORING SYSTEM:
- cornea: opacity (0 - 4) and effected area (0 - 4)
- iris: viability (0 - 4)
- conjunctiva: erythema (0 - 4), swell (0 - 4), secretion (0 - 4)
0 is no effect, 4 is a severe effect. The sum of all values from cornea, iris and conjunctiva is multiplied by 2. The mean value for all animals is divided by the number of animals (6). The score is determined at all points of observation (1, 7, 24, 48, 72 h after treatment). The highest score at any point of time is used for the assessment (worst case).
Overall scoring: 0 - 10: non irritant, 11 - 25: slightly irritant, 26 - 56: moderately irritant, 57 - 110: severely irritant
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks:
- 1 out of 5 rabbits with erythema still showed minimal reddening at 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.167
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 10
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 72 h
- Remarks:
- 1 out of 5 rabbits with erythema still showed minimal reddening at 72 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight irritation observed for conjunctivae.
- Other effects:
- None.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No irritation (overall scoring) was observed at 24/72 h mean after a 24h exposure with the pure substance on rabbits. The substance is not considered to be irritating to eyes according to CLP criteria.
Referenceopen allclose all
Endpoint |
1 h |
7 h |
24 h |
48 h |
72 h |
|
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
Area involved |
0 |
0 |
0 |
0 |
0 |
|
Mean Score A (max. 80) |
0 |
0 |
0 |
0 |
0 |
|
Iris |
Damage |
0 |
0 |
0 |
0 |
0 |
Mean Score B (max. 10) |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae sum of 6 rabbits |
Redness |
5 |
3 |
2 |
2 |
0 |
Chemosis |
1 |
1 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
|
Mean Score C (max. 20) |
2 |
1.3 |
0.7 |
0.7 |
0 |
|
Overall Mean |
Score |
2 |
1 |
1 |
1 |
0 |
Endpoint |
1 h |
7 h |
24 h |
48 h |
72 h |
|
Cornea |
Opacity |
6 |
5 |
0 |
0 |
0 |
Area involved |
15 |
12 |
0 |
0 |
0 |
|
Mean Score A (max. 80) |
12.5 |
10 |
0 |
0 |
0 |
|
Iris |
Damage |
0 |
0 |
0 |
0 |
0 |
Mean Score B (max. 10) |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Redness |
6 |
6 |
5 |
5 |
1 |
Chemosis |
11 |
9 |
3 |
0 |
0 |
|
Discharge |
11 |
9 |
3 |
0 |
0 |
|
Mean Score C (max. 20) |
9.3 |
8 |
3.7 |
2 |
0 |
|
Overall Mean |
Score |
22 |
18 |
4 |
2 |
0 |
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
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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