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EC number: 425-560-7 | 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
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- 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
Key, rabbit, OECD 404, GLP: negative
Eye irritation
Key, rabbit, OECD 405, GLP: negative
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:
- 8 JUL 1996 - 30 SEP 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- This study was conducted in compliance with the regulations for Good Laboratory Practice (GLP) in nonclinical laboratory studies and followed the OECD Guideline for Testing of Chemicals No 404.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute 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
- Strain: Albino rabbit, Crl:KBL(NZW)BR, female (f)
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: about 16 weeks
- Weight at study initiation: 2.80 (2.51 - 2.96) kg
- Housing: They were kept separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm2, height: 40 cm; manufacturer: Hulskamp) on metal grids. The paper underneath the cages was changed three times a week. The cages were machine-cleaned before the start of the study.
- Diet (e.g. ad libitum): ad libitum, Altromin Standard Diet TPF(R) 2113, pellets and acidified (The diet is checked periodically according to the specifications of the manufacturer by an independent laboratory, approved by the German government. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics. The analytical results show that the limits set by German regulations for animal feed have been followed.)
- Water (e.g. ad libitum): ad libitum, fully demineralized water
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 48 to 93
- Air changes (per hr): air-conditioned
- Photoperiod (hrs dark / hrs light): daylight - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 g test item was mixed with some drops aqua pro injectione
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- The rabbits were investigated for skin alterations, behaviour, and general condition 1 hour after removal of the patches, and then after 24, 48, 72 hours and then daily up to day 8 of the study.
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: 6 cm2 patches. The patch was kept in place by a self-adhesive fabric, Fixomull® stretch, Beiersdorf.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any test material left was wiped off after removal of the patches.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1 h, 24 h, 48 h, 72 h after removal of the patches and the daily until day 8 of the study
SCORING SYSTEM:
- Method of calculation:
Grading scale for evaluation:
Erythema and eschar formation
Scores
--------------------------------------------------
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to eschar
formation preventing grading of erythema 4
--------------------------------------------------
Maximum possible: 4
--------------------------------------------------
Edema formation
Scores
--------------------------------------------------
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well
defined by definite raising) 2
Moderate edema (raised approx. 1 mm) 3
Severe edema (raised more than 1 mm
and extending beyond area of exposure) 4
--------------------------------------------------
Maximum possible: 4
--------------------------------------------------
Total possible irritation score (maximum): 8
Mean score = Mean grading for erythema or edema of all the rabbits per time point
Mean cumulative score = Mean grading of all readings for erythema and edema per time point
Mean score per animal = Mean grading for each animal of erythema or edema (24, 48, and 72 hours after removal of the patches) - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- After a single application to the intact dorsal skin of rabbits, for a 4 hours period of exposure under semiocclusive conditions, no signs of irritation were observed in the treated areas.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- According to the result, the test material is not irritant to the skin.
- Executive summary:
The registered substance was tested for skin irritation in an Acute Dermal Irritation / Corrosion test according to OECD Guideline 404 following GLP.
Purpose
The purpose of this assay was to identify the skin irritation/corrosion potential of the test item when applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. This study should provide a rational basis for risk assessment to the irritating potential of the test item in human.
Study design
To test for primary skin irritation, the test substance was mixed with some drops of aqua pro injectione to ensure good contact to the skin. Afterwards the test material was spread onto patches and applied to the intact skin of three previously shaven rabbits for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then, examinations were performed daily for further 7 days.
Results
Under the conditions of the present study no signs of irritation were seen. The evaluation of all animals yields a zero mean score.
Conclusion
According to the result, the test material is not irritant to the skin.
Reference
Clinical findings
No signs of systemic toxicity were detected.
Mortality
All rabbits survived the 8 day observation period.
Body weight
Body weight development of the treated rabbits was inconspicuous.
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:
- 8 JUL 1996 - 25 SEP 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- This study was conducted according to Good Laboratory Practice (GLP) and followed the OECD guideline for testing of Chemicals 405.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute 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
- Strain: Albino rabbit, Crl:KBL(NZW)BR, female (f)
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: about 16 weeks
- Weight at study initiation: 2.84 (2.78 - 2.88) kg
- Housing: They were kept separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm2, height: 40 cm; manufacturer: Hulskamp) on metal grids. The paper underneath the cages was changed three times a week. The cages were machine-cleaned before the start of the study.
- Diet (e.g. ad libitum): ad libitum, Altromin Standard Diet TPF(R) 2113, pellets and acidified (The diet is checked periodically according to the specifications of the manufacturer by an independent laboratory, approved by the German government. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics. The analytical results show that the limits set by German regulations for animal feed have been followed.)
- Water (e.g. ad libitum): ad libitum, fully demineralized water
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 48 to 93
- Air changes (per hr): air-conditioned
- Photoperiod (hrs dark / hrs light): daylight - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 0.1 g test material was instilled into the conjunctival sac of the left eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test material was placed. The right eye remained untreated and served as control. After instillation, the eyelids were closed for about 30 seconds.
- Observation period (in vivo):
- The rabbits were investigated for eye irritation and for changes in behaviour and general condition 1 hour after treatment, and than after 24, 48, 72 hours and so on daily up to day 8 of the experimental part.
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- SCORING SYSTEM:
-- Evaluation of eye reactions
- Cornea Scores
A) Opacity-degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling
of normal lustre), details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacrous area, no details of iris visible, size of pupil barely
discernible 3
Opaque cornea, iris not discernible through the opacity 4
B) Area of cornea involved not evaluated (Rating according to the DRAIZE method)
- Iris
A) Normal 0
Markedly deepened rugae, congestion, swelling, moderate
circumcorneal hyperemia, or injection, any of these or combination
of any thereof, iris still reacting to light
(sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction
(any or all of these) 2
- Conjunctivae Scores
A) Redness (refers to palpebral and bulbar conjunctivae,
cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperemic (injected) 1
Diffuse, crimson color, individual vessels not easily discernible 2
Diffuse beefy red 3
B) Chemosis: lids and/or nictating membranes
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
C) Discharge (Rating according to the DRAIZE method )
No discharge 0
Any amount different from normal (does not include small
amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs,
and of a considerable area around the eye 3
Mean score of all animals = Mean grading for irritations of cornea, iris, and conjunctivae per time point
Mean score per animal = Mean grading for each animal of irritations of cornea, iris, and conjunctivae (1, 24, 48, and 72 hours after application)
Maximum value = Maximum grading of a sign of irritation within a period - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- After single instillation of 0.1 g test material, into the conjunctival sac of the left eye, no signs of irritation of the cornea and iris were observed. The conjunctivae showed redness (score 1) at the first reading and in one animal also at the second reading. Chemosis (scores 1 and 2) was seen in two animals at the first reading. Later on, no signs of irritation were seen.
The untreated eyes were normal. - Other effects:
- No signs of clinical toxicity were detected.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- According to the result of the irritation scores, the test material has not to be classified as an eye irritant.
- Executive summary:
The registered substance was tested for eye irritation in an Acute Eye Irritation / Corrosion test according to OECD Guideline 405 following GLP.
Purpose
The purpose of this primary eye irritation assay was to provide information on possible health hazards in case of acute eye contact with a test material and serve as a a rational basis for risk assessment to the eye irritating potential of the test item in human.
Study design
The test material was tested for eye irritation potential. 0.1 g of the test material was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The examinations were performed daily for further 7 days.
Results
No signs of irritation concerning to cornea and iris were observed. The conjunctivae showed redness (score 1), and chemosis (scores 1 and 2) at the first and second readings, maximally. This is a common finding in the case of powder. The untreated eyes were unchanged.The cumulative mean scores/group for cornea, iris, and conjunctivae were:
Study day
(hours)1
(1)2
(24)3
(48)4
(72)Cornea 0.0 0.0 0.0 0.0 Iris 0.0 0.0 0.0 0.0 Conjunctivae redness
chemosis1.0
1.00.3
0.00.0
0.00.0
0.0
The scores/animal (24, 48, 72 hours) were:
Mean Max Animal No. 14 13 12 14 13 12 Cornea 0.0 0.0 0.0 0 0 0 Iris 0.0 0.0 0.0 0 0 0 Conjunctivae redness
chemosis0.3
0.00.0
0.00.0
0.01
00
00
0
Conclusion
According to the result of the irritation scores, the test material has not to be classified as an eye irritant.
Reference
Ocular alterations
After single instillation of 0.1 g test material, into the conjunctival sac of the left eye, no signs of irritation of the cornea and iris were observed. The conjunctivae showed redness (score 1) at the first reading and in one animal also at the second reading. Chemosis (scores 1 and 2) was seen in two animals at the first reading. Later on, no signs of irritation were seen.
Clinical findings
No signs of irritation were observed at the cornea and iris. The conjunctivae showed redness (score 1) on day 1 of the study. Later on no signs of irritation were observed. The untreated eyes were unchanged.
No signs of clinical toxicity were detected.
Mortality
All animals survived the observation period.
Body weight
Body weight development of the treated rabbits was inconspicuous.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Acute Dermal Irritation / Corrosion test, OECD 404
The registered substance was tested for skin irritation in an Acute Dermal Irritation / Corrosion test according to OECD Guideline 404 following GLP.
Purpose
The purpose of this assay was to identify the skin irritation/corrosion potential of the test item when applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. This study should provide a rational basis for risk assessment to the irritating potential of the test item in human.
Study design
To test for primary skin irritation, the test substance was mixed with some drops of aqua pro injectione to ensure good contact to the skin. Afterwards the test material was spread onto patches and applied to the intact skin of three previously shaven rabbits for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then, examinations were performed daily for further 7 days.
Results
Under the conditions of the present study no signs of irritation were seen. The evaluation of all animals yields a zero mean score.
Conclusion
According to the result, the test material is not irritant for the skin.
Eye irritation
Acute Eye Irritation / Corrosion, OECD 405
The registered substance was tested for eye irritation in an Acute Eye Irritation / Corrosion test according to OECD Guideline 405 following GLP.
Purpose
The purpose of this primary eye irritation assay was to
provide information on possible health hazards in case of acute eye
contact with a test material and serve as a a rational basis for risk
assessment to the eye irritating potential of the test item in human.
Study design
The test material was tested for eye irritation potential.
0.1 g of the test material was applied into the conjunctival sac of
rabbits. The first examination of the eyes followed 1 hour after
instillation. The examinations were performed daily for further 7 days.
Results
No signs of irritation concerning to cornea and iris were
observed. The conjunctivae showed redness (score 1), and chemosis
(scores 1 and 2) at the first and second readings, maximally. This is a
common finding in the case of powder. The untreated eyes were unchanged.
The cumulative mean scores/group for cornea,
iris, and conjunctivae were:
Study day (hours) |
1 (1) |
2 (24) |
3 (48) |
4 (72) |
Cornea | 0.0 | 0.0 | 0.0 | 0.0 |
Iris | 0.0 | 0.0 | 0.0 | 0.0 |
Conjunctivae redness chemosis |
1.0 1.0 |
0.3 0.0 |
0.0 0.0 |
0.0 0.0 |
The scores/animal (24, 48, 72 hours)
were:
Mean | Max | |||||
Animal No. | 14 | 13 | 12 | 14 | 13 | 12 |
Cornea | 0.0 | 0.0 | 0.0 | 0 | 0 | 0 |
Iris | 0.0 | 0.0 | 0.0 | 0 | 0 | 0 |
Conjunctivae redness chemosis |
0.3 0.0 |
0.0 0.0 |
0.0 0.0 |
1 0 |
0 0 |
0 0 |
Conclusion
According to the result of the irritation scores, the test material has not to be classified as an eye irritant.
Justification for classification or non-classification
Based on the results of the key studies for in vivo skin and eye irritation, no classification for irritation is triggered in accordance with Regulation (EC) No 1272/2008.
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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