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EC number: 216-885-3 | CAS number: 1689-99-2
- 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:
- 22 Jun - 16 Jul 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 2021
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- 2,6-dibromo-4-cyanophenyl octanoate
- EC Number:
- 216-885-3
- EC Name:
- 2,6-dibromo-4-cyanophenyl octanoate
- Cas Number:
- 1689-99-2
- Molecular formula:
- C15H17Br2NO2
- IUPAC Name:
- 2,6-dibromo-4-cyanophenyl octanoate
- Test material form:
- liquid: viscous
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Crl: (HA) BR
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France (Saint-Aubin-les-Elbeuf, France)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 3 months
- Weight at study initiation: 342 ± 10 g (males), 345 ± 10 g (females)
- Housing: individually in polycarbonate cages equipped with dust-free sawdust (SICSA, Alfortville, France)
- Diet: 106 pelleted diet (UAR, Villemoisson-sur-Orge, France), ad libitum
- Water: filtered drinking water (0.22 µm FG Millipore membrane), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 12
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: From: 22 Jun 1999 To: 16 Jul 1999
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 0.1 mL at a concentration of 5% (w/w)
- Day(s)/duration:
- single injection on Day 1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 0.5 mL at a concentration of 50% (w/w)
- Day(s)/duration:
- starting on Day 8 for 48 h
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 0.5 mL at a concentration of 50% (w/w)
- Day(s)/duration:
- starting on Day 22 for 24 h
- No. of animals per dose:
- 10 (control, 5 per sex), 20 (treatment group, 10 per sex)
- Details on study design:
- RANGE FINDING TESTS
A. INDUCTION EXPOSURE
For intradermal induction: One male and one female guinea pig were each given intradermal injections of the following test item concentrations: 5% with or without FCA. The injection sites were evaluated 24 and 48 h and 6 days after the injections.
For topical induction: Two concentrations (25% and 50%) were tested on two guinea pigs. 0.5 mL of test substance formulation were placed on a dry gauze pad and applied to the skin by means of an occlusive dressing for 24 h. The skin reactions were evaluated 24 and 48 h after removal of the dressing. No skin reactions were recorded for both time points after topical application of the test formulations (25 - 50%).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) Freund's Complete Adjuvant (FCA)/sterile physicological saline solution
Injection 2: 5% test substance in corn oil
Injection 3: 5% test substance in corn oil in a 1:1 mixture of (v/v) FCA/0.9% NaCl
Epicutaneous: 50% test substance in corn oil
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/sterile physicological saline solution
Injection 2: corn oil
Injection 3: corn oil in a 1:1 mixture (v/v) FCA/0.9% NaCl
Epicutaneous: corn oil
- Site: interscapular region (intradermal + epicutaneous)
- Frequency of applications: once (each)
- Duration: intradermal induction was performed on Day 1, topical induction was performed on Day 8-10
- Concentrations: intradermal 5%, epicutaneous 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (challenge)
- Day(s) of challenge: challenge was performed three weeks after intradermal induction on Day 22
- Exposure period: 24 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: posterior flanks (right: test substance; left: vehicle)
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h after removal of dressing
OTHER:
The animals were observed for clinical signs and mortality at least once daily throughout the entire study period. Individual body weights were recorded on the day of allocation into the groups and on Days 1, 8, 15 and 25 of the study. - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- The GPMT was checked for reliability in a separate study on female guinea pigs using DNCB as a positive control substance.
Results and discussion
- Positive control results:
- The positive control DNCB at a concentration of 1% (w/w) induced positive skin sensitization reactions in 9/10 (90%) guinea-pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 5% (intradermal), 50% (epicutaneous); challenge: 50% (epicutaneous)
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0% (intradermal), 0% (epicutaneous); challenge: 50% (epicutaneous)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 5% (intradermal), 50% (epicutaneous); challenge: 50% (epicutaneous)
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0% (intradermal), 0% (epicutaneous); challenge: 50% (epicutaneous)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- induction: 0.1% (intradermal), 1% (epicutaneous); challenge: 1% (epicutaneous)
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group for positive control
- Dose level:
- induction: 0% (intradermal), 0% (epicutaneous); challenge: 0% (epicutaneous)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- induction: 0.1% (intradermal), 1% (epicutaneous); challenge: 1% (epicutaneous)
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group for positive control
- Dose level:
- induction: 0% (intradermal), 0% (epicutaneous); challenge: 0% (epicutaneous)
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
An ocular lesion recorded in one animal of the treated group (male no. 36), from Day 23, was not considered to be a consequence of treatment with the test substance. No other clinical signs and no mortality were observed during the study. The body weight gain of the treated animals was similar to that of the control animals. No cutaneous reactions were observed in the animals of the control group. In the treated group, a well-defined or moderate erythema (grade 2 or 3) was noted in all animals at the 24 and 48-hour readings. A very slight or slight oedema (grade 1 or 2) was recorded in 6/20 animals at the 24-hour reading and in 15/20 animals at the 48-hour reading. Dryness of the skin was observed in all animals at the 48-hour reading.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The study was conducted according to OECD guideline 406, under GLP and is considered valid and reliable. Under the test conditions, the test substance produced a sensitizing reaction to the skin of guinea pigs.
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