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EC number: 407-420-7 | 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Apr-May, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted equivalent or similar to EU Method B.6. and OECD Guideline 406 in compliance with GLP
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Barriered Animal Breeding Unit, ICI Pharmaceuticals, Alderley Park, Macclesfield, Cheshire, UK
- Age at study initiation: Young adults
- Weight at study initiation: 347-426 g females; 328-412 g males
- Housing: Individually housed in suspended cages (37cm length x 32cm width x 20cm height)
- Diet (e.g. ad libitum): Labsure RGP guinea pig diet, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period: Minimum of 6 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19±2 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- Sighting Study: intradermal injection (induction): 0.3, 1, 3 and 10 %.
Topical application (induction): 60 %
Topical application (challenge): 3, 10, 30 and 60 %
Main study: Induction: 30 and 60 %; Challenge: 30 & 60 % - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Sighting Study: intradermal injection (induction): 0.3, 1, 3 and 10 %.
Topical application (induction): 60 %
Topical application (challenge): 3, 10, 30 and 60 %
Main study: Induction: 30 and 60 %; Challenge: 30 & 60 % - No. of animals per dose:
- Sighting study: 2 or 4 guinea pigs and four dose-levels were on each group of animal
Main study: 30 females (20 test and 10 control) - Details on study design:
- RANGE FINDING TESTS: Sighting study
Intradermal injection (induction): Test substance in deionised water: 0.3, 1.0 and 10 %
Topical application (induction): Test substance in corn oil: 60 %: To determine the highest concentration which did not cause greater than a mild to moderate irritation response in animals that had been injected with Freund's Complete Adjuvant at least 14 d previously.
Topical application (challenge): Test substance in corn oil (3, 10, 30 and 60 %): To determine the highest concentration which did not produce irritation in animals that had been injected with Freund's Complete Adjuvant at least 14 d previously
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1-14 d
- Test groups: Yes
- Control group: Yes
- Site: Scapular region of each animal and a row of three injections (0.05-0.1 mL each) on each side of the mid-line
- Frequency of applications: 1 in 7 d.
- Duration: 14 d
- Concentrations: 30 & 60 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: Occlusive dressing consisted of four pieces of filter paper (1 cm x 1.5-2.0 cm) stitched to a piece of rubber sheeting (size 12cm x 5cm).
- Test groups: Yes, 30 & 60 % of test substance in corn oil( 0.05-0.1 mL)
- Control group: Yes
- Site: Scapular region of each animal and a row of three injections (0.05-0.1 mL each) on each side of the mid-line
- Concentrations: 60, 30, 10 and 3 %
- Evaluation (hr after challenge): 24 h
OTHER: As all the challenge sites were stained blue by the test sample, it was not possible to visually assess the inflammatory response and the 60% and 30% challenge sites were submitted for histopathological examination - Positive control substance(s):
- yes
- Remarks:
- 10% w/v preparation of a formaldehyde solution (40% w/v in water)
- Vehicle:
- other: Not applicable
- Concentration:
- Not applicable
- No. of animals per dose:
- Not applicable
- Details on study design:
- Not applicable
- Positive control substance(s):
- other: Not applicable
- Statistics:
- Not applicable
- Positive control results:
- Challenge with a 10 % w/v dilution of a 40 % w/v aqueous formaldehyde solution elicited an extreme skin sensitisation response in previously-induced guinea pigs
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: -.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: -.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: -.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: -.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10& 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10& 3 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: -.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10& 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10& 3 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: -.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 60 &30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60 &30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: -.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 60 &30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60 &30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: -.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10 %
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 10 %. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: -.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 10 %. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: -.
- Parameter:
- SI
- Remarks on result:
- other: Not applicable
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not applicable
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance is not a skin sensitizer in guinea pigs.
- Executive summary:
A study was conducted to assess the sensitizing potential of the test substance in guinea pigs (Magnusson & Kligman method) equivalent or similar to EU Method B.6. and OECD guideline 406.
Following challenge of previously-induced guinea pigs with 60, 30, 10 and 3% w/v suspensions of the test sample (corrected for water content) in corn oil the challenge sites were stained blue by the test sample. Skin samples were therefore submitted for histopathological examination.
Histopathological examination of the 60 and 30% w/v challenge sites indicated that the test sample was not a sensitiser. The test sample was, however, a mild skin irritant. It is considered very unlikely that histopathological examination of the 10 and 3% w/v challenge sites would have revealed evidence for a sensitisation response.
One test animal was killed due to irritation, prior to challenge, and this animal has therefore been excluded from the results.
In a positive control study, challenge of previously-induced guinea pigs with a 10% w/v dilution of a 40% w/v aqueous formaldehyde solution elicited an extreme skin sensitisation response.
Under the conditions of the present study, the test substance is not a skin sensitizer in guinea pigs (Parr-Dobrzanski R J & Leah AM, 1991).
Reference
Other observations:
Since all challenge sites were stained blue by the test sample, the inflammatory response could not be assessed visually. 60% and 30% challenge sites were examined histopathologically.
The examination showed a mild inflammatory reaction of slight focal, multifocal or diffuse acanthosis and minimal to slight focal or multifocal inflammatory cell infiltration at both challenge sites in test and control animals. The results indicate a mild skin irritation rather than sensitisation response. Results:Challenge of previously-induced guinea pigs with 60 and 30% w/v suspensions of the test sample in corn oil did not elicit a skin sensitisation response but did cause mild skin irritation.
It is considered very unlikely that histopathological examination of the 10 and 3% w/v challenge sites would have revealed evidence for a sensitisation response.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was conducted to assess the sensitizing potential of the test substance in guinea pigs (Magnusson & Kligman method) equivalent or similar to EU Method B.6. and OECD guideline 406.
Following challenge of previously-induced guinea pigs with 60, 30, 10 and 3% w/v suspensions of the test sample (corrected for water content) in corn oil the challenge sites were stained blue by the test sample. Skin samples were therefore submitted for histopathological examination.
Histopathological examination of the 60 and 30% w/v challenge sites indicated that the test sample was not a sensitiser. The test sample was, however, a mild skin irritant. It is considered very unlikely that histopathological examination of the 10 and 3% w/v challenge sites would have revealed evidence for a sensitisation response.
One test animal was killed due to irritation, prior to challenge, and this animal has therefore been excluded from the results.
In a positive control study, challenge of previously-induced guinea pigs with a 10% w/v dilution of a 40% w/v aqueous formaldehyde solution elicited an extreme skin sensitisation response.
Under the conditions of the present study, the test substance is not a skin sensitizer in guinea pigs (Parr-Dobrzanski R J & Leah AM, 1991).
Migrated from Short description of key information:
The test substance showed no evidence for sensitizing properties in guinea pigs.
Justification for classification or non-classification
The test substance was negative in in vivo skin sensitisation test and therefore no classification is required for sensitisation according to EC criteria (67/548/EEC) and CLP criteria (EC 1272/2008).
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