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EC number: 406-670-4 | CAS number: 61203-83-6
- 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:
A study was performed according to OECD 404 under GLP conditions. To test for primary skin irritation the test item was applied to intact skin of rabbits for a 4 hour period under occlusive conditions. Under the conditions of the study, the test item did show slight irritation to the skin. However, the test item is not requiring classification for skin irritation according to (EC) No 1272/2008 (reference 7.3.1 -1).
Eye irritation:
A study was performed according to OECD 405 under GLP conditions. To test for primary eye irritation the test item was instilled into the conjunctival sac of rabbits. In the primary eye irritation test no irritation of the cornea was observed. The conjunctivae showed redness and discharge at the first reading up to day 4, maximally. The test item is not requiring classification for skin irritation according to (EC) No 1272/2008 (reference 7.3.2 -1).
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:
- February 12 until February 26, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAVO-lvanovas, Kisslegg
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: mean 2.87 (2.77 - 2,98) kg
- Housing: kept separately in cages type KK 017
- Diet: ad libitum, acidified, fully demineralized water from an automatic drinking device
- Water: ad libitum, Altromin Standard Diet TPF 2113
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 38-56
- Photoperiod (hrs dark / hrs light):12/12
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- 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:
- 14 days
- Number of animals:
- 3 (1m and 2f )
- Details on study design:
- TEST SITE
- Area of exposure: 24 hours before the start of the study the backs and flanks of the animals were cautiously shaved with an electronic clipper so that the skin stayed intact.
- Type of wrap: The application sites were wrapped with polyethylene foil which was kept in place by leather sleeve.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: After 4 hours of occlusive exposure the patches were removed and any test material left was wiped off.
OBSERVATION TIME POINTS
The rabbits were investigated for skin alterations, behavior, and general condition 1 hour after removal of the patches, and then daily for a period of further 14 days.
All rabbits were weighed before start of the study and on days 5, 8, 11 and 15.
SCORING SYSTEM:
- Method of calculation: Skin changes at the application site were evaluated according to the DRAIZE and OECD recommendations. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- - Other adverse local effects:
Single application of 0.5 mL test item to the intact dorsal skin of rabbits led to irritation of the skin.
Beginning from day 2, and then up to day 7 of the study, erythema and edema were observed. They were followed by other irritation symptoms i.e. formation of large scales and smaller scales from day 5 up to day 12.
- Other adverse systemic effects:
No signs of systemic toxicity were detected. The body weight development was normal. All rabbits survived the 15 day observation period. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, the test item did show slight irritation to the skin. However, the test item is not requiring classification for skin irritation according to (EC) No 1272/2008.
- Executive summary:
A study was performed according to OECD 404 under GLP conditions. To test for primary skin irritation the test item was applied to intact skin (for a 4 hour period under occlusive conditions) of rabbits. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then examinations were performed daily for a further 14 days. The skin irritation test revealed slight irritation. Beginning at the second reading, up to day 7 of the study, erythema and edema occurred (max. score 1), which from day 5 up to 12 were followed by other irritation symptoms, i.e. formation of large scales and smaller scales. Under the conditions of the present study, the test item did show slight irritation to the skin. However, the test item is not requiring classification for skin irritation according to (EC) No 1272/2008.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
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:
- February 12 until February 26, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: SAVO-lvanovas, Kisslegg
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: mean 2.73 (2.66 - 2.80) kg
- Housing: kept separately in cages type KK 017
- Diet: ad libitum, acidified, fully demineralized water from an automatic drinking device
- Water: ad libitum, Altromin Standard Diet TPF 2113
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 38-56
- Photoperiod (hrs dark / hrs light):12/12
To ensure that only rabbits without ocular abnormalities were included in the study, 24 hours before treatment ophthalmological examinations were performed after instillation of 0.15 % fluorescein solution using an ophthalmoscope after Eisenhut. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 (1m and 2f)
- Details on study design:
- The rabbits were investigated for eye irritation and for changes in behavior and general condition 1 hour after treatment and then daily for a period of further 7 days. All rabbits were weighed before the start of the study and on days 5 and 8.
- Washing: no
SCORING SYSTEM: Local changes of the eye were evaluated according to the recommendations of the OECD
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- other: discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- other: discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- other: discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1-3
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Other effects:
- - Ophthalmoscopic findings:
No irritation of the cornea was observed. At one reading (animal No. 90013, day 3) congestion of the iris was observed. Examination of the conjunctivae revealed redness and discharge beginning at the first reading up to day 4, maximally.
- Other observations:
No signs of systemic toxicity were seen. The body weight development was normal. All animals survived the 8 day observation period. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the results of this study the test material is not to be classified as an irritant for eyes.
- Executive summary:
A study was performed according to OECD 405 under GLP conditions. To test for primary eye irritation the test item was instilled into the conjunctival sac of rabbits (left eye). The right eye served as untreated control. The first examination of the eyes was performed 1 hour after instillation. Then examinations were performed daily for 7 days. In the primary eye irritation test no irritation of the cornea was observed. Congestion of the iris (value 1) was seen in one rabbit on day 3. The conjunctivae showed redness and discharge at the first reading up to day 4, maximally.The test item is not requiring classification for skin irritation according to (EC) No 1272/2008.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
A study was performed according to OECD 404 under GLP conditions. To test for primary skin irritation the test item was applied to intact skin (for a 4 hour period under occlusive conditions) of rabbits. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then examinations were performed daily for a further 14 days.The skin irritation test revealed slight irritation. Beginning at the second reading, up to day 7 of the study, erythema and edema occurred (max. score 1), which from day 5 up to 12 were followed by other irritation symptoms, i.e. formation of large scales and smaller scales.Under the conditions of the present study, the test item did show slight irritation to the skin. However, the test item is not requiring classification for skin irritation according to (EC) No 1272/2008 (reference 7.3.1 -1).
Eye irritation:
A study was performed according to OECD 405 under GLP conditions. To test for primary eye irritation the test item was instilled into the conjunctival sac of rabbits (left eye). The right eye served as untreated control. The first examination of the eyes was performed 1 hour after instillation. Then examinations were performed daily for 7 days. In the primary eye irritation test no irritation of the cornea was observed. Congestion of the iris (value 1) was seen in one rabbit on day 3. The conjunctivae showed redness and discharge at the first reading up to day 4, maximally. The test item is not requiring classification for skin irritation according to (EC) No 1272/2008 (reference 7.3.2 -1).
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data for skin irritation and eye irritation are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is neither considered to be classified for skin irritation nor for eye irritation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) No 2019/521.
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