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EC number: 212-161-6 | CAS number: 766-09-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- use of potentially corrosive concentrations.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- use of potentially corrosive concentrations.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- EPA 712-C-03-197, March 2003
- Deviations:
- yes
- Remarks:
- use of potentially corrosive concentrations.
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Species:
- guinea pig
- Strain:
- other: Crl:HA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratory Animal Breeders, Kisslegg, Germany
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: 346 - 400 g
- Housing: two or five per cage kept in Noryl cages, Tecniplast Deutschland GmbH, Hohenpeissenberg, Germany
- Diet: "PROVIMI KLlBA 3420 - Maintenance Diet for Guinea Pigs" supplied by PROVOMI KLlBA AG, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 (possibly drifting higher at outdoor temperatures above 24°C)
- Humidity (%): 40-70
- Air changes (per hr): ≥ 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 1st induction: 6%; 2nd and 3rd induction: 3%; Challenge: 3%
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 1st induction: 6%; 2nd and 3rd induction: 3%; Challenge: 3%
- No. of animals per dose:
- 20 females (in test groups)
10 females (controls) - Details on study design:
- RANGE FINDING TESTS:
In a first dose range-finding test three concentrations and the vehicle were tested in each case on five guinea pigs (animal nos. 1-5). The suitable areas of the body were shaved one day (24 hours) before the treatment. The patches loaded with 0.5 ml of the test item formulations (25% and 50%), the test item (100%) or the vehicle were applied to each animal under occlusive conditions for 6 hours. At the end of the exposure period the animals showed following clinical signs: temporary tremor, spasmodic state and prostration.
The treated skin areas appeared corroded. Because of the clinical signs and the strong skin effects the animals were sacrificed.
In a second dose range-finding test three additional concentrations and the vehicle were tested. Each concentration and the vehicle were tested on three guinea pigs. The right flanks of the body were shaved one day (24 hours) before the treatment. The patches loaded with 0.5 ml of the test item formulations (1%; 3% and 6%) or the vehicle were applied to each animal under occlusive conditions for 6 hours. At the end of the exposure period, the remaining test item was removed with sterile physiological saline solution. Twenty-one hours later the treated areas were shorn.
The dermal reactions were evaluated 30 and 54 hours after the start of the application.
Because of the toxic effect of the test item observed during the first dose range finding study, each animal was only treated with one test item concentration in this study.
There were no skin effects in the animals treated with 1, 3, and 6 % test item at the evaluation time points of 30 and 54 hours after start of application.
Because of this negative result a 12% test item formulation was tested in a third dose range-finding test. The left flanks of 4 animals of the second dose range-finding test were shaved one day (24 hours) before the treatment. The third dose range-finding test was carried out as described for the second study. At 30 and 54 hours readings, the treatment area was black coloured and appeared corroded.
Thereafter, one further animal of the second dose rangefinding test was shaved on the right and left flank and treated with three test item concentrations to check the overall toxicity of the test item at the concentrations selected for the main study.
With the 12 % test item formulation the treatment area was black coloured in places and appeared corroded, as observed in the third range finding study. The animal showed no clinical signs.
Selection of the dose for the inductions:
Based on the results of the dose range-finding studies, the following concentration was selected for the first induction: 6%
Because of the strong skin effects after the 1st induction the dose was reduced to 3% for the 2nd and 3rd induction.
The test item concentrations for the challenge was determined in a dose range-finding study using 2 guinea pigs which were treated during the inductions in the same manner as the control animals. The patches loaded with 0.5 ml of test item formulations or the vehicle were applied to each animal under occlusive conditions for 6 hours. At the end of the exposure period, the remaining test item was removed with sterile physiological saline solution. Twenty-one hours later the treated areas were shorn. The dermal reactions were evaluated 30 and 54 hours after the start of the application.
There were no skin effects in the animals at the evaluation time points of 30 and 54 hours after treatment with 1, 3, and 6 % test item.
Based on the results of the dose range-finding study, the concentration of 3 % was selected for the challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
The animals were dermally treated with the test item three times at intervals of seven days. The suitable areas of the body were shaved one day (24 hours) before each treatment. After removal of the patches, any remaining test item was removed with sterile physiological saline solution.
- No. of exposures: 3 times at intervals of seven days
- Exposure period: 6 h
- Test groups: Hypoallergic patches loaded with the test item in pysiol. saline were held in place on the skin using "ORABAND"® adhesive plaster
- Control group: Hypoallergic patches were loaded with physiol. saline
- Site: left flank (1st induction); right flank (2nd and 3rd induction)
- Frequency of applications: every 7 days
- Duration: 0 - 21 days
- Concentrations: 6 % (1st induction); 3 % (2nd and 3rd induction)
- Volume applied per animal: 0.5 mL.
The treatment areas were visually assessed 30 hours after initiation of exposure. For this, the treatment areas were not shorn or chemically depilated.
B. CHALLENGE EXPOSURE
The challenge was performed two weeks after the last dermal induction.
For the challenge backs and right flanks of the animals were shorn 30 minutes prior to the challenge treatment.
The volume applied per animal was 0.5 mL.
At the end of the exposure period, the patches were removed and the remaining test item was rinsed away with sterile physiological saline solution.Twentyone hours later the skin of the animals was shorn in the region of the treatment sites.
- No. of exposures: 1
- Day(s) of challenge: 35
- Exposure period: 6 h
- Test groups: Hypoallergic patches loaded with the test item formulation were applied and fixed in place on the skin with a ORABAND self-adhesive tape.
- Control group: As a control, a patch loaded only with the vehicle was applied and fixed also to the right flank, cranial to the test item patch.
- Site: right flank (in test groups), right flank, cranial to the test item patch (control)
- Concentrations: 3 %
- Evaluation (hr after challenge): 30 and 54 h
OTHER:
TREATMENT PREPARATION AND ADMINISTRATION:
The test item was formulated in sterile physiological saline solution to yield a solution (1% - 3%) or an emulsion (6% - 50%).
The emulsions were continuously homogenized on a magnetic stirrer during the treatments.
The stability and homogeneity of the test item formulations in the vehicle were analytically verified for up to 2 hours.
GRADING:
0 = No reaction
1 = Slight localized redness
2 = Moderate confluent redness
3 = Severe redness and swelling
EVALUATION:
The criterion for existence of sensitization was taken to be the occurrence of skin reactions in the test item group animals at a higher incidence and greater intensity than in the control animals. A test item is interpreted to be sensitizing if by comparison with the control group 15% or more of the test group animals reacted positive. - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- alpha hexyl cinnamic aldehyde formulated in polyethylene glycol 400. Epicutaneous inductions were performed using a 40% test item formulation and challenge with 20%
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- negative control
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: negative control. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- positive control
- Dose level:
- 20 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- 40 % of the animals exhibit skin effects (grade 1).
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: positive control. Dose level: 20 %. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: 40 % of the animals exhibit skin effects (grade 1). .
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
Reference
After the first induction with 6% test item formulation 6 of 20 animals of the test item group showed severe skin effects (grey-black hardened area with red surrounding on the treatment area, size up to 1 * 0.5 cm, like corroded) and 2 of 20 animals revealed skin redness (grade 1). There were no skin effects in the animal of the control group.
After the second and third induction with 3% test item formulation no skin effects in the animals of the test item group and control group were observed.
The 1st induction was carried out on the left flank with 6% test item formulation, the 2nd and 3rd induction on the right flank with 3% test item concentration because of the strong skin effects mentioned after the 1st induction.
The skin effects mentioned were most probably due to corrosive properties of the test item.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are valid in vivo data available for the assessment of the sensitisation potential of the test item.
In the key study, a dermal sensitisation study with the test item (analytical purity: 100 %) in physiological saline in total 30 female Crl:HA guinea pigs (20 animals for the treatment group and 10 control animals) were tested using the Buehler epicutaneous patch test according to the OECD Guideline 406 (Bayer, T9075962, 2006). In a preliminary dose finding study with two animals the concentration of 6 % was identified as the maximal non-irritating concentration. Epicutaneous, occlusive induction and challenge was performed using the closed patch method. A solution of 6 % test substance was applied occlusively for a exposure period of 6 hours for the first induction. Thereafter, 8 of 20 animals of the treatment group showed severe skin effects; no effects were observed in animals of the control group treated with the vehicle alone. Due to the severe skin effects, the second and third induction every 7 days was performed with a 3 % test item formulation. Accordingly, no skin effects in animals of the treatment group and the control were observed. Challenge was performed in the same way with an exposure period of 6 hours. As a positive control alpha hexyl cinnamic aldehyde formulated in polyethylene glycol 400 were used for epicutaneous inductions (40% test item formulation) and challenge (20%).
30 and 54 hours after challenge no skin effects in the animals of the test item group and no skin effects in the control group were observed. The positive control induced the appropriate response.
The dermal sensitisation study is acceptable (reliability 1), and does satisfy the guideline requirements for a sensitization study (OECD 406) in guinea pigs.
Under the conditions of the Buehler Patch Test, the test item exhibits no dermal sensitisation potential.
Migrated from Short description of key information:
Buehler test (guinea pigs, concentration 3 % ): not sensitising, Val. 1 (GLP, OECD 406 Guideline; Bayer 2006)
Justification for selection of skin sensitisation endpoint:
Only one study available.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
There are no data available concerning the sensitisation potential to the respiratory system.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data for sensitisation are reliable and suitable for the purpose of classification under Directive 67/548/EEC. As a result the substance is not warranted to be classified for sensitisation under Directive 67/548/EEC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data for sensitisation are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. As a result the substance is not warranted to be classified for sensitisation, under Regulation (EC) No.1272/2008.
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