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EC number: 947-603-3 | 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
No responses were provoked during induction or after challenge exposure by the test chemical. Animals showed normal body weight changes and remained in good health throughout the study. Under the conditions of the study, test chemical displayed no strong allergic contact sensitization potential and it can be considered to be not sensitizing to skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Weight of evidence approach based on the available data of the read-across chemicals.
- Justification for type of information:
- Weight of evidence approach based on the available data of the read-across chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE report is based on Skin sensitization study for read across chemicals.
- GLP compliance:
- no
- Species:
- guinea pig
- Strain:
- other: 2. Dunkin-Hartley 3.Not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 2. TEST ANIMALS
- Weight at study initiation: weight range of 278 - 342 g,
- Housing: All animals were maintained in galvanized plasticized cages with solid floors
- Diet (e.g. ad libitum): complete pelleted guinea-pig diet supplemented daily with autoclaved hay, ad
libitum
- Water (e.g. ad libitum): tap water, ad libitum
3. Not specified - Route:
- epicutaneous, open
- Vehicle:
- N,N-dimethylformamide
- Concentration / amount:
- 0.1 ml of 10% w/v suspension in 50% aqueous DMF
- Day(s)/duration:
- 48 hrs
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 ml of 0.05-0.1%
- Day(s)/duration:
- 21 days
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- N,N-dimethylformamide
- Concentration / amount:
- 0.05 ml of 10,1, 0.1% w/v suspension in 50% aqueous DMF
- Day(s)/duration:
- 24 hrs
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- other: Not specified
- Vehicle:
- not specified
- Concentration / amount:
- No data available
- Day(s)/duration:
- Not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 2. 10
6 -test group
4- control group
3. Not specified - Details on study design:
- 2. MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 24 hours
- Test groups: 6
- Control group: 4
- Site: outer surface of the ears
- Frequency of applications: daily for 3 days
- Duration: 24hours
- Concentrations: 0.1ml of 10% w/v suspension in 50% aqueous dimethylformamtde (DMF)
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 1 day
- Exposure period: 24 hours
- Test groups: 6
- Control group: 4
- Site: clipped flanks
- Concentrations: 10%, 1% and 0.1% w/v suspensions in 50% aqueous DMF
- Evaluation (hr after challenge): 24 hours after exposure
OTHER: On Day 7, any erythema which develops at each site was rated on a 5-point scale. Amongst
the pre-treated animals, only erythema in excess of that present in the controls was considered to
denote sensitization; that present in the controls denotes simple primary irritation.
3. MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 doses
- Exposure period: Not specified
- Test groups: Not specified
- Control group: Not specified
- Site: Not specified
- Frequency of applications: 10 doses in 21 days
- Duration: 21 days
- Concentrations: 1 ml 0.05-0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: Not specified
- Day(s) of challenge: 1
- Exposure period: Not specified
- Test groups: Not specified
- Control group: Not specified
- Site: Not specified
- Concentrations: Not specified
- Evaluation (hr after challenge ): Not specified
OTHER: Challenge was provided 14 days after induction - Challenge controls:
- 2. no data available
3.Not specified - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%, 1% and 0.1% w/v suspensions in 50 0/1 aqueous DMF
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 2.
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 1 ml 0.05-0.1%
- No. with + reactions:
- 0
- Clinical observations:
- No skin allergic reactions were observed.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 3.
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No responses were provoked during induction or after challenge exposure by the test chemical. Animals showed normal body weight changes and remained in good health throughout the study. Under the conditions of the study, test chemical displayed no strong allergic contact sensitization potential and it can be considered to be not sensitizing to skin.
- Executive summary:
The allergic contact sensitization potential of the test chemical was assessed by the ear/flank method in the guinea-pigs. Ten Dunkin-Hartley male and female guinea-pigs were used for this test. On Days 0, 1, and 2 of the test, 0.1ml of 10% w/v suspension in 50% aqueous dimethylformamtde (DMF) was applied to the outer surface of the ears of six animals only. On Day 6, 0.05 ml of 10%, 1% and 0.1% w/v suspensions in 50% aqueous DMF was applied topically to the clipped flanks of all ten animals. On Day 7, any erythema which develops at each site was rated on a 5-point scale. Amongst the pre-treated animals, only erythema in excess of that present in the controls was considered to denote sensitization; that present in the controls denotes simple primary irritation. No responses were provoked during induction or after challenge exposure by the test chemical. Animals showed normal bodyweight changes and remained in good health throughout the study. Under the conditions of the study, test chemical displayed no strong allergic contact sensitization potential and it can be considered to be not sensitizing to skin.
In another study, The test chemical was used as a test material to evaluate skin sensitization potential on guinea pig skin .The test material was given sub-cuteneously in the concentration 1 ml 0.05-0.1% in isotonic saline , 10 doses for 21 days . Challenge test was provided 14 days after induction . No skin allergic reactions were observed. Hence , the test chemical was considered to be not sensitizing to guinea pig skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The allergic contact sensitization potential of the test chemical was assessed by the ear/flank method in the guinea-pigs. Ten Dunkin-Hartley male and female guinea-pigs were used for this test. On Days 0, 1, and 2 of the test, 0.1ml of 10% w/v suspension in 50% aqueous dimethylformamtde (DMF) was applied to the outer surface of the ears of six animals only. On Day 6, 0.05 ml of 10%, 1% and 0.1% w/v suspensions in 50% aqueous DMF was applied topically to the clipped flanks of all ten animals. On Day 7, any erythema which develops at each site was rated on a 5-point scale. Amongst the pre-treated animals, only erythema in excess of that present in the controls was considered to denote sensitization; that present in the controls denotes simple primary irritation. No responses were provoked during induction or after challenge exposure by the test chemical. Animals showed normal bodyweight changes and remained in good health throughout the study. Under the conditions of the study, test chemical displayed no strong allergic contact sensitization potential and it can be considered to be not sensitizing to skin.
In another study, The test chemical was used as a test material to evaluate skin sensitization potential on guinea pig skin .The test material was given sub-cuteneously in the concentration 1 ml 0.05-0.1% in isotonic saline , 10 doses for 21 days . Challenge test was provided 14 days after induction . No skin allergic reactions were observed. Hence , the test chemical was considered to be not sensitizing to guinea pig skin.
Justification for classification or non-classification
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
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