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EC number: 443-860-6 | CAS number: 302776-68-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-04-18 until 2000-05-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF guideline, 59 Noh San No. 4200, January 28,1985
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed before LLNA was formally validated and available as OECD guideline in 2002.
Test material
- Reference substance name:
- -
- EC Number:
- 443-860-6
- EC Name:
- -
- Cas Number:
- 302776-68-7
- Molecular formula:
- C24 H31 N O4
- IUPAC Name:
- hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, FRG.
- Age at study initiation: Young adult animals
- Weight at study initiation: 327 - 375 g
- Housing: 5 animals per cage. Stainless steel wire mesh cages with plastic-coated grating. Minimum floor area: 2000 cm2.
- Diet: Kliba Labordiät (Kaninchen-Meerschweinchen-Haltungsdiät) ad libitum. Provimi Kliba SA, Kaiseraugst, Switzerland.
- Water: Tap water ad libitum
- Acclimation period: 7 days before the beginning of the study in the laboratory
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- For the intradermal induction: 5% of test substance
For the epicutaneous induction: 25% of test substance
For the challenge: 25% of the test substance
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- For the intradermal induction: 5% of test substance
For the epicutaneous induction: 25% of test substance
For the challenge: 25% of the test substance
- No. of animals per dose:
- Main test:
Number of animals per control group: 5
Number of animals of the test group: 10 - Details on study design:
- RANGE FINDING TESTS:
The concentrations of the test substance suitable for use in the main experiment were determined in a pretest (intradermal and epicutaneous):
- Intradermal Pretest
Amount applied:
6 intradermal injections in groups of two per animal were applied to each animal.
A) front row 2 injections each of 0.1 mL Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1: 1
B) middle row. 2 injections each of 0.1 mL of a test substance formulation in an appropriate vehicle (olive oil) at the selected concentration (5%)
C) back row 2 injections each of 0.1 mL Freund's adjuvant /0.9% aqueous NaCl-solution (1: 1) with test substance at the selected concentration (5%)
Site of application: shoulder
No. of animals: 2 per test substance concentration
Reading: 24 h after the beginning of application
- Epicutaneous Pretest
Amount applied:
2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing 0.5 mL of the test substance formulation were applied to the skin of the flanks under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (5 x 5 cm from Pfaelzische Verbandstoff-Fabrik) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
Exposure period:
The test substance was applied 2 times for 24 hours within a period of 96 hours
Site of application: flank, on the same area respectively
Number of test animals: 5 per test concentration
Readings: 24 h and 48 h after the beginning of application
Concentrations applied: 10%, 25% in olive oil
Applicability:
- After injection of 5% test substance preparation in olive oil or in Freund's adjuvant / 0.9% aqueous NaCl-solution (1 :1) with a syringe the concentration was well-tolerated locally and systemically.
- The application of a 25% test substance preparation in olive oil did not cause any skin reaction (48 hours after beginning of application).
The following concentrations for induction and the challenge were selected on the basis of the pretest:
Intradermal induction: Test substance 5% in olive oil or 5% in Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1)
Epicutaneous induction: Test substance 25% in olive oil
Challenge test substance: Test substance 25% in olive oil
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures and concentrations: 2 exposures:
1. Intradermal induction that included 6 injections to each animal of the test group as follows:
A) front row: 2 injections each of 0.1 mL Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCI-solution in a ratio of 1: 1
B) middle row: 2 injections each of 0.1 mL of 5% test substance in olive oil
C) back row: 2 injections each of 0.1 mL Freund's adjuvant /0.9% aqueous NaCl-solution (1: 1) with test substance- 5%.
Site of application: shoulder
Reading: 24 h after the beginning of application
2. Epicutaneous induction: 2 x 4 cm gauze containing 25 % test substance in olive oil (1 mL of the test substance formulation was applied to each animal) under occlusive dressing.
- Dressing: 2 x 4 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test substance formulation were applied to the skin of the shoulder under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 6 cm from Russka) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
- Exposure period: The epicutaneous induction was carried out one week after the intradermal induction. 14 days after the intradermal induction, the challenge exposure was performed.
- Test groups: One test group that contains 10 animals
- Control group: 2 control groups (5 animals per group). Each animal in these control groups got the same induction exposure (intradermal and epicutaneous) treatments as written above but without the test substance.
- Site: The site of the injections (intradermal induction) and the gauze patches (epicutaneous induction) were at the same area on the shoulder. For the exact location of the different injections see above.
- Frequency of applications and duration: One time 6 injections for each animal (intradermal induction) and one time application of the patches in the epicutaneous induction which lasted 48 hours.
B. CHALLENGE EXPOSURE
- No. of exposures: One time challenge exposure
- Day(s) of challenge: 14 days after the epicutaneous induction.
- Site of application:
test substance formulation: posterior right flank
vehicle: posterior left flank
- Application / amount applied:
- Dressing: 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. ) containing the test substance formulation were applied to the skin of the flank under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG. 0.5 mL l of the test substance formulation was applied to each animal.
- Concentrations: 25% of the test substance in olive oil (0.5 mL on 2x2 cm gauze patches-occlusive dressing)
- Exposure period: The challenge exposure lasted 24 hours
- Test groups: 1 test group
- Control group: One control test (control group 1) was treated with the test substance as the test group (in both groups each animal was also applied with olive oil as a vehicle control on the other side of the flank). Whereas the other control group (control group 2) received only olive oil ( no challenge exposure).
- Evaluation (hr after challenge): 24 and 48 hours after the removal of the patch. - Challenge controls:
- Control group 1 which had induction exposure without the test substance but a challenge exposure like the test group, i.e. with the test substance. In case of a borderline results at the (first) challenge exposure the control group 2 (which had no exposure induction and no challenge induction) were kept for a potential second challenge.
- Positive control substance(s):
- yes
- Remarks:
- A positive control with a known sensitizer is performed in separate study ttwice a year with Alpha-Hexylcinnamaldehyde techn. 85%. The test system proved to be able to detect sensitizing compounds under the laboratory conditions chosen.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- This data refers to control group 1 (see below).
- 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: This data refers to control group 1 (see below)..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- This data refers to control group 1 (see below).
- 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: This data refers to control group 1 (see below)..
Applicant's summary and conclusion
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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