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EC number: 453-480-2 | 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
- 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
The read across for substance, CAS: 70851-04-6; EC: 453-480-2; is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint skin sensitisation. Based on the information available for the read across substances, the substance is not expected to be a skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Composition of test substance unclear.
- Principles of method if other than guideline:
- Local Lymph Node Assay was performed in mice to investigate the skin sensitizing potential of the test substance.
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Vehicle:
- other: Acetone
- Concentration:
- 3%, 10% and 30%
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
- Name of test method: ß-scintillation counting
- Criteria used to consider a positive response:
1. The increase in isotope incorporation for at least one concentration tested must be three-fold or more compared to the control (vehicle treated) mice.
2. The data generated must be compatible with the biological dose response.
TREATMENT PREPARATION AND ADMINISTRATION:
Samples were administered to the dorsum of both ears using a micro-pipette.
Groups of 4 female mice were dosed with 25 µl of either vehicle (acetone) or a 30%, 10% or 3% preparation of the test item on three consecutive days on the dorsum of both ears. Five days after initial dosing, the animals received approx. 20 µCi of 3H-methyl thymidine, were sacrificed 5 h later and radioactive counts/lymph node were measured. - Key result
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index was 0.45 for the 3% application, 2.05 for 10% and 1.21 for the 30% application.
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: No significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) was 0.0022 Cpm and 0.0047 for the vehicle controls and 0.001, 0.0045 and 0.0057 for 3%, 10% and 30%, respectively.
- Interpretation of results:
- other: inconclusive
- Remarks:
- Criteria used for interpretation of results: EU
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Significant methological deficiencies (only basic study data reported, no positive control, only 2 concentrations tested, test substance not defined).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- (only basic study data reported, no positive control, only 2 concentrations tested, test substance not defined)
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- No Data
- Vehicle:
- other: Acetone
- Concentration:
- 3% or 10%
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
- Name of test method: ß-scintillation counting
- Criteria used to consider a positive response:
1. The increase in isotope incorporation for at least one concentration tested must be three-fold or more compared to the control (vehicle treated) mice.
2. The data generated must be compatible with the biological dose response.
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of 4 female mice were dosed with 25 µl of either vehicle (acetone) or a 10% or 3% preparation of the test item on three consecutive days on the dorsum of both ears. Five days after initial dosing, the animals received approx. 20 µCi of 3H-methyl thymidine, were sacrificed 5 h later and radioactive counts/lymph node were measured. - Key result
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index was 3.13 for the 3% application and 6.87 for the 10% application.
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: A significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) increased dose-dependently from 0.0015 Cpm (Vehicle) to 0.0047 and 0.0103 for 3% and 10%, respectively.
- Interpretation of results:
- other: inconclusive
- Remarks:
- Criteria used for interpretation of results: EU
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only short summary available (no data on test substance purity).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- Only summary provided, no data on test substance purity
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- other: No Data
- Strain:
- not specified
- Sex:
- not specified
- Vehicle:
- not specified
- Concentration:
- 1%, 3% and 10%
- No. of animals per dose:
- No Data
- Key result
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index was 1.3 for the 1% application, 1.19 for 3% and 1.54 for the 10% application.
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: No significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute)/Lymph node was 0.011 Cpm for the vehicle control and 0.0143, 0.0131 and 0.017 for 1%, 3% and 10%, respectively.
- Interpretation of results:
- other: inconclusive
- Remarks:
- Criteria used for interpretation of results: EU
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (no information on purity of the test material; both flanks were exposed during challenge, no reliability check done, no positive control used. Method given in very summarized form).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no information on purity of the test material; both flanks were exposed during challenge, no reliability check done, no positive control used. Method given in very summarized form.
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A valid test was available from 1991 (before REACH came into force), therefore no additional LLNA test was performed.
- Species:
- guinea pig
- Strain:
- other: Albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 344 - 441 g - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction: 100%
Challenge: 30% and 100% - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction: 100%
Challenge: 30% and 100% - No. of animals per dose:
- 20 (10 for the controls)
- Details on study design:
- RANGE FINDING TESTS: No Data
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: Undiluted test sample
- Control group: not stated
- Site: scapular region
- Frequency of applications: 7 d interval
- Duration: 14 d
- Concentrations: undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28, 14 d after final induction
- Exposure period: 6 h
- Test groups: undiluted (100%) and 30% (w/v in corn oil)
- Control group: undiluted (100%) and 30% (w/v in corn oil)
- Site: undiluted (100%) on left flank and 30% on right flank
- Concentrations: undiluted (100%) and 30% (w/v in corn oil)
- Evaluation (hr after challenge): 24 h and 48 h - Challenge controls:
- No
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- not sensitising
- Conclusions:
- CLP: not classified
DSD: not classified - Endpoint:
- skin sensitisation
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- QSAR prediction
- Guideline:
- other: REACH guidance on QSARs R.6, May/July 2008
- Principles of method if other than guideline:
- (Q)SAR conducted with OECD Application Toolbox; Version 1.1.02
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- skin sensitisation, other
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- 1 substances available for read-across
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- see the attached justification in Section 13 for full details
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Remarks:
- CAS 68424-31-7 (1991a)
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Remarks:
- CAS 68424-31-7 (1991a)
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Remarks:
- CAS 68424-31-7 (1991a)
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Remarks:
- CAS 68424-31-7 (1991a)
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Remarks:
- CAS 68424-31-7 (1991a)
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- CAS 68424-31-7 (1991a)
- Key result
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index was 0.45 for the 3% application, 2.05 for 10% and 1.21 for the 30% application.
- Remarks:
- (1991b)
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: No significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) was 0.0022 Cpm and 0.0047 for the vehicle controls and 0.001, 0.0045 and 0.0057 for 3%, 10% and 30%, respectively.
- Remarks:
- (1991b)
- Key result
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index was 1.3 for the 1% application, 1.19 for 3% and 1.54 for the 10% application.
- Remarks:
- CAS 68424-31-7 (1992)
- Key result
- Parameter:
- other: disintergrations per minute (DPM)
- Remarks on result:
- other: No significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute)/Lymph node was 0.011 Cpm for the vehicle control and 0.0143, 0.0131 and 0.017 for 1%, 3% and 10%, respectively.
- Key result
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index was 3.13 for the 3% application and 6.87 for the 10% application.
- Remarks:
- CAS 68424-31-7 (1991c)
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: A significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) increased dose-dependently from 0.0015 Cpm (Vehicle) to 0.0047 and 0.0103 for 3% and 10%, respectively.
- Remarks:
- CAS 68424-31-7 (1991c)
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The read across for substance,CAS: 70851-04-6; EC: 453-480-2; is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint skin sensitisation. Based on the information available for the read across substances, the substance is not expected to be a skin sensitiser.
Referenceopen allclose all
Table 1: Results of the ß-scintillation counting
Test Concentration |
Cpm/Lymph Node (x 10-2) |
Test/Control Ratio |
Vehicle |
0.22 |
- |
3% w/v |
0.10 |
0.45 |
10% w/v |
0.45 |
2.05 |
Vehicle |
0.47 |
- |
30% w/v |
0.57 |
1.21 |
Table 1: Results of the ß-scintillation counting
Test Concentration |
Cpm/Lymph Node (x 10-2) |
Test/Control Ratio |
Vehicle |
0.15 |
- |
3% w/v |
0.47 |
3.13 |
10% w/v |
1.03 |
6.87 |
The increase in radioactive counts/lymph node seen between vehicle and 3% and 10% of the test compound implies a sensitizing potential. Only two concentrations were tested preventing a conclusive interpretation.
Table 1: Results of the ß-scintillation counting
Test Concentration |
Cpm/Lymph Node (x 10-2) |
Test/Control Ratio |
Vehicle |
1.1 |
- |
1% w/v |
1.43 |
1.3 |
30% w/v |
1.31 |
1.19 |
10% w/v |
1.7 |
1.54 |
The test substance is unlikely to be a sensitiser under the conditions of the test.
Reading: other: QSAR prediction. Group: other: QSAR prediction. Clinical observations: negative for skin sensitization .
Reading: other: QSAR prediction. Group: other: QSAR prediction. Clinical observations: negative for skin sensitization . (CAS 68424 -31 -7 OECD Toolbox 2010)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The read across for substance, CAS: 70851-04-6; EC: 453-480-2 is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint skin sensitisation. Based on the information available for the read across substances, the substance is not expected to be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
All available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) 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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