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EC number: 700-893-3 | 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
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:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- 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: Charles River France
- Age at study initiation: 4 w
- Weight at study initiation: 256 - 295 g
- Housing: groups of 2 or individually
- Environmental enrichment: tunnel
- Diet (ad libitum): SDS – FD1 guinea pig breeding and maintenance diet
- Water (ad libitum): tap water
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): ca. 15
- Photoperiod (light): 7:00 - 19:00 - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- The test substance was prepared in isotonic saline for the intradermic injections and in distilled water for the topical applications. At 50 % a homogeneous white paste was obtained.
Intradermal induction, applying to 2 injections of 0.1 mL each of:
- Freund's Complete Adjuvant diluted by 50 % in isotonic NaCl
- test substance at 3.125 % in isotonic NaCl
- a mixture 1 + 1 v/v of Freund's Complete Adjuvant at 50 % and test substance at 6.25 % in isotonic NaCl
For the negative control the test substance was replaced by isotonic NaCl
Topical induction:
0.5 mL of the test substance diluted at 50 %.
For the negative control: distilled water.
Challenge exposure:
50 % and 25 % test substance for both groups. - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- The test substance was prepared in isotonic saline for the intradermic injections and in distilled water for the topical applications. At 50 % a homogeneous white paste was obtained.
Intradermal induction, applying to 2 injections of 0.1 mL each of:
- Freund's Complete Adjuvant diluted by 50 % in isotonic NaCl
- test substance at 3.125 % in isotonic NaCl
- a mixture 1 + 1 v/v of Freund's Complete Adjuvant at 50 % and test substance at 6.25 % in isotonic NaCl
For the negative control the test substance was replaced by isotonic NaCl
Topical induction:
0.5 mL of the test substance diluted at 50 %.
For the negative control: distilled water.
Challenge exposure:
50 % and 25 % test substance for both groups. - No. of animals per dose:
- 5 in the negative control group + 10 in the test substance group
- Details on study design:
- The animals were carefully shorn before each item application:
- on the inter-scapular zone for the induction phase.
- on the dorso-lumbar zone for the challenge phase.
At least 3 hours before the first reading (challenge phase) they were shorn a second time in this dorsolumbar zone.
The animals were weighed at the beginning and at the end of the main test.
RANGE FINDING TESTS:
For the results: see the attachment.
To determine the maximal non-necrotizing concentration after intradermal injection: No necrosis was observed at 3.125 %.
To determine the pre-maximal non-irritant concentration after topical application: No cutaneous reaction, except for depilation in one animal, was observed at 50 %.
To determine the maximal non-irritant concentration after topical application: No cutaneous reaction was observed at 50 %.
MAIN STUDY
A. INDUCTION EXPOSURE
1st Intradermal Induction on Day 0. After shearing the scapular zone, three pairs of intradermal injections (ID) of 0.1 mL were performed on the scapular zone in such a way as an injection on each pair is placed to either side of the spine.
2nd Topical induction on Day 6 the scapular zone of all the animals in each group, shorn beforehand, was brushed with 0.5 mL of a
solution of sodium lauryl sulfate at 10 % in thick vaseline, in order to create a local irritation. On Day 7 a topical application under occlusive dressing for 48 hours was performed on the injection sites of each animal. Day 9: Removal of the occlusive dressing.
B. CHALLENGE EXPOSURE
Day 20: The experimental procedure of this phase is identical for both groups (Negative control and (Treated). On the previously shorn dorso-lumbar zone, an application on either side of the spine, under occlusive dressing, is performed during 24 hours:
- 1 sample cup containing the test item diluted at 50 % and 1 sample cup containing the test item at 25 %. Day 21: Removal of the occlusive dressing. - Positive control results:
- Historical positive control data with hexylcinnamaldehyde are presented in the report.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No abnormalities.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No abnormalities..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Depilation was noted 3/5 animals. Otherwise: no abnormalities.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Depilation was noted 3/5 animals. Otherwise: no abnormalities..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No abnormalities.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No abnormalities..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Depilation was noted 3/5 animals. Otherwise: no abnormalities.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Depilation was noted 3/5 animals. Otherwise: no abnormalities..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No abnormalities..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Slight erythema in 1/10 animals. Dryness of the skin of 1/10 animals, otherwise no abnormalities.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Slight erythema in 1/10 animals. Dryness of the skin of 1/10 animals, otherwise no abnormalities..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No abnormalities..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Dryness of the skin of 1/10 animals, otherwise no abnormalities.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Dryness of the skin of 1/10 animals, otherwise no abnormalities..
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not considered to be a sensitiser.
- Executive summary:
A possible allergic activity of the test substance was investigated in the Guinea Pig Maximisation Test. A slight erythema was noted in 1/10 treated animals at 50 % test substance concentration in water, but not at 25 %. No other cutaneous reactions were recorded in the treated and the negative control groups at the challenge exposure. The test substance is not considered to be a sensitiser.
Reference
The mean and the summary results are presented in the attachment.
No cutaneous reaction was recorded after the first induction. During the second induction, dryness was noted in 8/10 treated and 3/5 control animals and scab was noted in 1/5 control animals, 24 h after the removal of the dressing.
The body weight development was inconspicuous. No mortality was noted.
Historical positive control data with hexylcinnamaldehyde are presented in the report.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Justification for selection of skin sensitisation endpoint:
Key study.
Justification for classification or non-classification
There is no justification which would justify a classification.
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