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EC number: 261-332-1 | CAS number: 58567-11-6
- 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
Skin irritation (OECD 404), rabbit: irritating
Eye irritation (OECD 405): 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:
- key study
- Study period:
- from 1994-10-18 to 1994-12-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study performed under GLP without deviations
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, D-97633 Sulzfeld.
- Age at study initiation: not reported
- Weight at study initiation: 2.0 - 2.5 kg
- Housing: individual caging in metal wire cages
- Diet (e.g. ad libitum): Altromin 2023 diet for rabbits, ad libitum
- Water (e.g. ad libitum): tap water from an automatic watering system, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5
- Humidity (%): 50 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 1994-10-18 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Hair was clipped on the dorsal area of the trunk one day before the application
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patch removal. Additional examinations 6, 8 and 10 days after patch removal.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: median on the dorsal thoracal region
- % coverage: test substance spread over an area of approximately 6 cm2
- Type of wrap if used: plastic collar
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was wiped off using wet cellulose tissue
- Time after start of exposure: 4 hours
SCORING SYSTEM:
ERYTHEMA/ESCHAR FORMATION
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) or eschar formation (injuries in depth)
OEDEMA FORMATION
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well defined by definite raising)
3: Moderate oedema (raised approximately 1 mm)
4: Severe oedema (raised more than 1 mm and extending beyond area of exposure) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Other effects:
- Animal 1: Eschar formation after 72 hours. Eschar almost completely desquamated after 6 days and completely desquamated after 8 days, with intact skin below.
Animal 2: No additional observations.
Animal 3: Eschar on four sites, diameter approximately 1 mm each from 48 hours to 8 days. On day 8, eschar completely desquamated, intact skin below. - Interpretation of results:
- other: EU CLP criteria
- Remarks:
- Skin irritating (Category 2)
- Conclusions:
- The substance is irritating to the skin.
- Executive summary:
The potential of the substance to induce skin irritation was investigated in a GLP study in conformance with OECD TG 404.
0.5 mL test substance was applied to the intact skin of 3 rabbits in a semi-occlusive application. After 4 hours, residual test substance was wiped off. Animals were examined for erythema/eschar and oedema as well as for other local and systemic signs approximately 1, 24, 48 and 72 hours after patch removal. Additional examinations were performed 6, 8 and 10 days after patch removal. The mean of the erythema/eschar scores at 24, 48 and 72 hours was 3.3, 2.0 and 3.7 in animal 1, 2 and 3, respectively.
The mean of the oedema scores at 24, 48 and 72 hours was 3.7, 2.0 and 4.0. Scores returned to "0", i. e. normal, within 8 days after patch removal in 2/3 animals respectively within 10 days after the end of exposure in the third animal.
In conclusion, the substance has to be regarded as irritating to the skin.
Reference
Scores of the application sites
Time after the end of exposure |
Erythema / Eschar formation |
Oedema formation |
||||
Animal No |
1041 |
1042 |
1043 |
1041 |
1042 |
1043 |
1 h |
2 |
2 |
2 |
3 |
3 |
3 |
24 h |
2 |
2 |
3 |
3 |
2 |
4 |
48 h |
4 |
2 |
4 |
4 |
2 |
4 |
72h |
4 |
2 |
4 |
4 |
2 |
4 |
mean(24-72h) |
3.3 |
2.0 |
3.7 |
3.7 |
2.0 |
4.0 |
6 d |
2 |
1 |
4 |
2 |
1 |
4 |
8 d |
0 |
0 |
1 |
0 |
0 |
2 |
10 d |
|
|
0 |
|
|
0 |
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study performed under GLP without deviations
- 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
- Species:
- rabbit
- Strain:
- other: SPF albino rabbits of the stock Mol:Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre Ltd., Ejby, DK-4623 Lille Skensved
- Age at study initiation: not reported
- Weight at study initiation: 2.5 - 2.6 kg
- Housing: caged single in PPL cages with perforated floor
- Diet (e.g. ad libitum): free access to feed pellets
- Water (e.g. ad libitum): free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- The eyes were examined and the grade of ocular reaction was recorded 1 and 24 hours after application. After the first 24 hour reading, Fluoreszein was instilled. After rinsing with 20 mL 0.9% sodium chloride solution, the eyes were examined again using UV-light to detect possible corneal damage. The eyes were also examined 48 and 72 hours as well as on day 7 after the treatment.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
CORNEA:
Opacity degree of density (Area most dense taken for reading)
0: No ulceration or opacity
1: Scattered or diccuse area of opacity (other than slight dulling of normal luster), details of iris clearly visible.
2: Easily discernible translucent areas, details of iris slightly obscured.
3: Nacreous areas, no details of iris visible, size of pupil barely discernible
4: Complete corneal opacity, iris not discernible
Area of cornea involved
1: One quarter (or less) but not 0
2: More than 1 quarter, but less than half
3: More than half, but less than 3 quarters
4: More than 3 quarters, up to whole area
IRIS
0: Normal
1: Markedly deepened folds, congestion, swelling, moderate circumcorneal injection (any of these or combination of any thereof), iris still reacts to light (sluggish reaction is positive)
2: No reaction to light, haemorrhage, gross destruction (any or all of these)
CONJUNCTIVA
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
0: vessels normal
1: Some vessels definitely injected
2: Diffuse, crimson red, individual vessels not easily discernible
3: Diffuse beefy red
Chemosis
0: No swelling
1: Any swelling above normal (includes nictitating membrane)
2: Obvious swelling with partial eversion of lids
3: Swelling with lids about half closed
4: Swelling with lids more than half closed
Discharge
0: No discharge
1: Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2: Discharge with moistening of the lids and hairs just adjacent to lids
3: Discharge with moistening of the lids and hairs, and considerable area around the eye
TOOL USED TO ASSESS SCORE: hand held inspection lamp fitted with white and UV-light with 2 x magnification, fluorescein (after first 24 hour reading) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Redness
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- other: EU CLP criteria
- Remarks:
- not classified
- Conclusions:
- The substance was not irritating to the eye under the conditions of the test.
- Executive summary:
The primary eye irritant effect of the test substance was investigated according to OECD TG 405.
Three female albino rabbits were exposed to 0.1 mL of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48, 72 and on day 7 hours after dosing. After the treatment, only slight changes were observed in the eyes. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated: Cornea opacity: 0/4, iris lesion: 0/2, redness of conjunctiva: 1/3, odema of conjunctiva: 0.8/4.
It is concluded that the test substance caused no eye irritation under the conditions of the test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The potential of the registration item to induce skin irritation was investigated in a GLP study in accordance with OECD TG 404 (1994). 0.5 mL test substance was applied to the intact skin of each of 3 rabbits in a semi-occlusive application. After 4 hours, residual test substance was wiped off. Animals were examined for erythema/eschar and edema as well as for other local and systemic signs approximately 1, 24, 48 and 72 hours after patch removal. Additional examinations were performed 6, 8 and 10 days after patch removal. The mean of the erythema/eschar scores at 24, 48 and 72 hours was 3.3, 2.0 and 3.7 in animal 1, 2 and 3, respectively. The mean of the edema scores at 24, 48 and 72 hours was 3.7, 2.0 and 4.0. The skin was normal within 8 days after patch removal in 2/3 animals respectively within 10 days after the end of exposure in the third animal. In conclusion, the substance has to be regarded as irritating to the skin.
Eye irritation
The primary eye irritant effect of the registration item was investigated in a GLP study according to OECD TG 405 (1995). Three female albino rabbits were exposed to 0.1 mL of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48, 72 hours and on day 7 after dosing. After the treatment, only slight changes were observed in the eyes. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated: Cornea opacity: 0/4, iris lesion: 0/2, redness of conjunctiva: 1/3, edema of conjunctiva: 0.8/4. It is concluded that the test substance caused no eye irritation under the conditions of the test.
Justification for classification or non-classification
Skin irritation
The mean value for erythema/eschar and for edema from grading at 24, 48 and 72 hours after patch removal was ≥ 2,3 - ≤ 4,0 in 2 of the tested animals.
Based on the above stated assessment of the skin irritation potential, the substance needs to be classified as skin irritant Category 2 according to Regulation (EC) No. 1272/2008 (CLP).
Eye irritation
All effects were fully reversible within 7 days and the mean scores following grading at 24, 48 and 72 hours after installation of the test material were below 1 for corneal opacity and iritis and below 2 for conjunctival redness and conjunctival edema. According to Regulation (EC) No. 1272/2008 (CLP), the substance has thus not to be classified as irritating to the eyes.
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