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EC number: 241-629-2 | CAS number: 17647-86-8
- 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 (BASF internal Standard, 4h): not irritating (BASF, 1979)
skin irritation (Draize Test, 24 h): slightly irritating (BASF, 1979)
eye irritation (BASF internal Standard): irreversible damage after 8 days (BASF, 1979)
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable study report
- Principles of method if other than guideline:
- according to Fed. Reg. 38, No. 187, § 1500.41, 1973
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- The animals were offered a standardized animal laboratory diet
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin served as control
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 8 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
The substance was not washed off after application - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Skin scales formation after 72 h to the end of the observation periode (8 days)
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Skin scales formation after 72 h to the end of the observation periode (8 days)
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Skin scales formation at the end of the observation periode (8 days)
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Skin scales formation after 72 h to the end of the observation periode (8 days)
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24, 72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: within 8 days
- Remarks on result:
- other: Skin scales formation after 72 h to the end of the observation periode (8 days)
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24, 72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Skin scales formation after 72 h to the end of the observation periode (8 days)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 3.75
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 1.85
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: abraded skin
- Irritant / corrosive response data:
- All animals showed slight erythema after treatment. Four out of six animals developed slight edema. After 8 days (intact skin) all animals showed scaling of the skin but no erythema or edema.
- Other effects:
- The skin findings were pathologically confirmed.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable study report
- Principles of method if other than guideline:
- according to Fed. Reg. 38, No. 1987, § 1500.42, 1973 (Draize test)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- The animals were offered a standardized animal laboratory diet.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent eye served as control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The test substance was not washed out.
SCORING SYSTEM: Draize Scale - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: Cornea score after 8 days: 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Animal #1 developed iritis with a score of 1 after 8 days.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Following the experimental design
according to Federal Register 38, No. 187, § 1500.41, S. 27019, 27.
Sept. 1973 0.5 mL of a 45 % solution of the test substance with water
was applied to the intact and abraded skin of six rabbits (BASF, 1979).
The application to the intact skin resulted in slight irritation after
24 hours (4/6 slight erythema and oedema; 2/6 questionable erythema) and
after 72 hours (3/6 questionable; 1/6 slight; 2/6 no erythema; 5/6 no
oedema). After 8 days (intact skin) all animals showed scalling of the
skin but no erythema or oedema.
For the abraded skin slight to severe irritation was observed after 24
hours (6/6 slight oedema; 1/6 slight erythema; 1/6 marked erythema; 4/6
severe erythema). After 72 hours all animals had developed severe
erythema in the form of necrosis. Slight oedema was only observed in 1
out 6 animals after 72 hours. The erythema effects still existed after 8
days. No oedema was observed at the end of the study period. Based on
the findings on the intact skin, the test substance is slightly skin
irritating.
The skin irritation potential of the test substance was also assessed in
a study comparable to OECD guideline 404 (BASF, 1979). 1 mL of the test
substance was applied to the intact skin of two rabbits under an
occlusive dressing for 4 hours. The test substance was washed off with
water after the exposure time. No oedema was observed over the entire
observation period (8 days). One animal developed very slight erythema
which dissolved by the end of the observation period. According to the
results of this study, the substance is not irritating to the intact
skin of rabbits.
Eye irritation
Following the experimental design according to Federal Register 38,
No. 187, § 1500.42, S. 27019, 27. Sept. 1973, 0.1 mL of the test
substance was instilled in the conjunctival sac of six rabbits (BASF,
1979). The eyes were not washed after 24 hours of exposure. Animals were
observed for 8 days. Irritation was scored by the method of Draize et
al..
The application to the intact eye resulted in marked redness of the
conjunctivae in all 6 animals lasting up to day 8. Slight to marked
chemosis was observed in all animals but was reversible in 5/6 animals
until day 8. Iritis was not observed in all animals. Two animals
developed questionable symptoms after 24 hours which were resolved after
48 hours. Very slight symptoms of corneal opacity were observed in 3/6
animals which lasted up to the end of the observation period in two
animals with increasing symptoms (marked opacity).
According to the above findings, the substance causes serious eye damage.
Justification for selection of skin irritation / corrosion endpoint:
scientifically acceptable study report
Justification for selection of eye irritation endpoint:
scientifically acceptable study report
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: highly irritating
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance needs to be classified and labelled as eye damage cat. 1, H318 "Causes serious eye damage" under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221.
The test substance showed a slight skin irritating potential, but does not need to be classified and labelled under Regulation (EC) No 1272/2008, as ammended for the seventh time in Regulation (EC) No 2015/1221.
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