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EC number: 213-584-9 | CAS number: 989-38-8
- 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: The test substance is not irritating to the skin.
Eye irritation: The test substance causes serious eye damage.
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Refer to section 'Principles of method if other than guideline'
- Principles of method if other than guideline:
- Deviation from OECD guideline 404:
- BASF-method, 20h exposure
- Occlusive type of coverage instead of semi-occlosive.
- Exposure period of 20 h instead of 4 hours.
- Observation period of 8 days instead of 14 days.
The named deviations from the OECD guideline 404 represents a tightening of the test conditions. - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.24 and 3.04 kg - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: 50% solution - Duration of treatment / exposure:
- 20 hours
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: Back and ear of the rabbits
- % coverage: Back: 2.5 x 2.5 cm
OBSERVATION TIME POINTS: 24 hours and 8 days
SCORING SYSTEM:
- Method of calculation: Draize method - Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #2
- Time point:
- other: 20 hours
- Remarks on result:
- no indication of irritation
- Remarks:
- red substance residues
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #2
- Time point:
- other: 20 hours
- Remarks on result:
- no indication of irritation
- Remarks:
- red substance residues
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test material is not considered to cause corrosion or irritation to the skin.
- Executive summary:
An skin irritation potential of the test substance was investigated in an in vivo study performed equivalent to OECD guideline 404. A 50% solution of the test substance in water was applied to the shaved skin of two Vienna White rabbits. The test was performed under occlusive conditions for an exposure period of 20 hours. The skin was scored for signs of irritation after 24 hours and 8 days. Under the conditions of this test no indication of skin irritation was observed.
The performed skin irritation test showed some deviations from the OECD guideline 404. For example the test item was tested under occlusive instead of semi-occlusive conditions. Further, an exposure period of 20 hours instead of 4 hours was applied. The named deviations from the OECD guideline 404 represents a tightening of the test conditions. Based on the results of this test, the test substance is considered not irritating to the skin.- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Refer to section 'Principles of method if other than guideline'
- Principles of method if other than guideline:
- Deviation from OECD guideline 405:
- End of the observation period after 8 days.
- No test substance removal. - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 mg
- Observation period (in vivo):
- 10 min, 1 h, 2 h, 24 h, 48 h, 96 h, 7d and 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: Draize method
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 3 - ca. 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #2
- Time point:
- 48 h
- Max. score:
- 4
- Remarks on result:
- other: This time point was not measured
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 1 and #2
- Time point:
- 72 h
- Remarks on result:
- other: This time point was not measured
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 8 d
- Score:
- ca. 3 - ca. 4
- Max. score:
- 4
- Remarks on result:
- other: corrosion, ulceration
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 3 - ca. 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 8 d
- Score:
- ca. 3 - ca. 4
- Max. score:
- 4
- Remarks on result:
- other: corrosion, ulceration
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 and #2
- Time point:
- 48 h
- Max. score:
- 4
- Remarks on result:
- other: This time point was not measured
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 and #2
- Time point:
- 72 h
- Max. score:
- 4
- Remarks on result:
- other: This time point was not measured
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 8 d
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: corrosion, ulceration
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 8 days
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: corrosion, ulceration
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Max. score:
- 2
- Remarks on result:
- other: Not indicated in study report
- Irritation parameter:
- iris score
- Basis:
- animal: #1 and #2
- Time point:
- 48 h
- Max. score:
- 2
- Remarks on result:
- other: This time point was not measured
- Irritation parameter:
- iris score
- Basis:
- animal: #1 and #2
- Time point:
- 72 h
- Max. score:
- 2
- Remarks on result:
- other: This time point was not measured
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 8 d
- Max. score:
- 2
- Remarks on result:
- other: Not indicated in study report
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Max. score:
- 2
- Remarks on result:
- other: Not indicated in study report
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 8 d
- Max. score:
- 2
- Remarks on result:
- other: Not indicated in study report
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Max. score:
- 3
- Remarks on result:
- other: Not indicated in study report
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 8 d
- Max. score:
- 3
- Remarks on result:
- other: Not indicated in study report
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Max. score:
- 3
- Remarks on result:
- other: Not indicated in study report
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 8 d
- Max. score:
- 3
- Remarks on result:
- other: Not indicated in study report
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #2
- Time point:
- 48 h
- Max. score:
- 3
- Remarks on result:
- other: This time point was not measured
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #2
- Time point:
- 72 h
- Max. score:
- 3
- Remarks on result:
- other: This time point was not measured
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions of this test, test substance causes serious eye damage.
- Executive summary:
The eye irritation potential of the test substance was investigated in a study performed equivalent to OECD guideline 405. The unchanged test substance (50 mg) was applied to the eyes of two Vienna White rabbits. The test substance was not removed and the eyes were assessed for irritation after 10 min, 1 h, 2 h, 24 h, 48 h, 96 h, 7d and 8 days. The application of the undiluted substance caused irreversible damage to the eyes of the rabbits. After 8 days the eyes of both animals showed severe edema, as well as corrosion and ulceration were observed. Based on the study results, the test substance causes serious eye damage and has to be classified as eye damaging cat. 1, H318.
- 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:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
An skin irritation potential of the test substance was investigated
in an in vivo study performed equivalent to OECD guideline 404. A 50%
solution of the test substance in water was applied to the shaved skin
of two Vienna White rabbits. The test was performed under occlusive
conditions for an exposure period of 20 hours. The skin was scored for
signs of irritation after 24 hours and 8 days. Under the conditions of
this test no indication of skin irritation was observed.
The performed skin irritation test showed some deviations from the OECD
guideline 404. For example the test item was tested under occlusive
instead of semi-occlusive conditions. Further, an exposure period of 20
hours instead of 4 hours was applied. The named deviations from the OECD
guideline 404 represents a tightening of the test conditions. Based on
the results of this test, the test substance is not considered
irritating to the skin.
Additionally, a disseminated dossier for the characteristically similar
substance,
3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium
chloride (CAS 3068-39-1) is available on the ECHA Homepage. Based on the
QSAR Toolbox (version 4.2) similarity options, both substances share a
very high degree of similarity with a similarity value of 92.54%. For
CAS 3068-39-1 a primary skin irritation study according to OECD
guideline 404 is available. Under the conditions of this study, the test
material is not considered to cause corrosion or irritation to the skin.
Thus, the skin irritation data of CAS 3068-39-1 supports the skin
irritation result for the test substance (CAS 989-38-8).
Eye irritation:
The eye irritation potential of the test
substance was investigated in a study performed equivalent to OECD
guideline 405. The unchanged test substance (50 mg) was applied to the
eyes of two Vienna White rabbits. The test substance was not removed and
the eyes were assessed for irritation after 10 min, 1 h, 2 h, 24 h, 48
h, 96 h, 7d and 8 days. The application of the undiluted substance
caused irreversible damage to the eyes of the rabbits. After 8 days the
eyes of both animals showed severe edema, as well as corrosion and
ulceration were observed. Based on the study results, the test substance
causes serious eye damage and has to be classified as eye damaging cat.
1, H318.
Additionally, a disseminated dossier for the characteristically similar
substance,
3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium
chloride (CAS 3068-39-1) is available on the ECHA Homepage. Based on the
QSAR Toolbox (version 4.2) similarity options, both substances share a
very high degree of similarity with a similarity value of 92.54%.
According to study data with CAS 3068-39-1, the substance is also
damaging to the eyes. Thus, the eye irritation data of CAS 3068-39-1
supports the eye irritation result for the test substance (CAS 989-38-8).
Justification for classification or non-classification
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The available experimental test
data are reliable and suitable for classification purposes under
Regulation (EC) No 1272/2008. Based on available data on skin and eye
irritation/corrosion, the test item is classified as eye damaging cat.
1, H318 (Causes serious eye damage) according to Regulation (EC) No
1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No
2017/776.
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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