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EC number: 229-542-8 | CAS number: 6600-31-3
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 528.9 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 146.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.16 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4.16 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Vulkazon AFS (CAS 6600-31-3)
(3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5,5]undecane)
DNELs (worker)
Repeated dose toxicity
A subacute oral gavage study rats was evaluated for the derivation of DNELs of Vulkazon AFS.
Basis for delineation of the DNEL:
Study (rat study) Repeated dose study rat, male, female, subacute oral gavage study for 28 days rat: 0 (control), 100, 300 or 1000 mg/kg bw/d – male, female via gavage
Effects, NOAEL
NOEL = 300 mg/kg bw/d (male + female rats)
Effects: Body weights were unaffected up to 300 mg/kg body weight in males and in all female dose groups. At 1000 mg/kg body weights of male rats were transiently significantly reduced. The test item had no effect on food and water intake of all treated females and of low and mid dose males. High dose males consumed more food and water related to body weight.
Reference
Wirnitzer U (2012 draft) Repeated Dose Systemic Toxicity Study in Wistar Rats (4-Weeks Daily Administration by Gavage)
Bayer Pharma AG GDD-GED General Toxicology 42096 Wuppertal Germany
Study n°: T3082698
1.) Long-term tocixity – systemic effects (worker)
Long-term oral or dermal route-systemic effects (worker) using default extrapolation factors:
NOEL(rat, male) from a subacute toxicity study: 300 mg/kg bw/day
Penetration oral compared to dermal: 1
For interspecies rat vs. human: 4
For remaining interspecies differences: 1*
For intraspecies differences in workers: 3**
For extrapolation of exposure duration subacute to chronic: 6
For reliability of dose-response: 1
For quality of whole database: 1
Overall factor: 72
Worker DNEL long-term for oral or dermal route-systemic: 4.16 mg/kg bw/day
* An assessment factor of 1 is used for “remaining interspecies differences” because of the low absorption potential of the compound (see chapter toxicokinetic) and the low toxicity profile. Overall it is likely that bioavailability is very low and consequently toxicodynamic parameters are of minor significance.
** An assessment factor of 3 is used due because of the low absorption potential of the compound (see chapter toxicokinetic) and the low toxicity profile. Overall it is likely that bioavailability is very low and intraspecies differences in humans based on differences in human toxicokinetoc and metabolism is of limited significance.
Long-term inhalation route-systemic effects (worker):
NOEL(rat) from a subacute toxicity study:300 mg/kg bw/day Correction of the starting point according TGD Figure R.8-3: Corrected inhalatory NOEC = Oral NOEL (300 mg/kg) x 1/0.38 m³/kg x 6.7 m³/10m³ => NOEC worker = 528.9 mg/m³
For interspecies differences rat vs. human:1 (according TGD Table R.8-4. already covered by correction of starting point)
For remaining interspecies differences: 1*
For intraspecies differences in workers: 3**
For extrapolation of exposure duration subacute to chronic: 6
For reliability of dose-response: 1
For quality of whole database: 1
Overall factor: 18
Worker DNEL long-term for inhalation exposure: 29.3 mg/m³
* An assessment factor of 1 is used for “remaining interspecies differences” because of the low absorption potential of the compound (see chapter toxicokinetic) and the low toxicity profile. Overall it is likely that bioavailability is very low and consequently toxicodynamic parameters are of minor significance.
** An assessment factor of 3 is used due because of the low absorption potential of the compound (see chapter toxicokinetic) and the low toxicity profile. Overall it is likely that bioavailability is very low and intraspecies differences in humans based on differences in human toxicokinetoc and metabolism is of limited significance.
2.) Short-term toxicity – systemic effects (workers)
Concerning the systemic effects an exceeding factor of 5 based on the DNEL for long term exposure seems justified.
Worker DNELshort-term for oral or dermal route-systemic: 20.8 mg/kg bw/day
Worker DNEL short-term for inhalation exposure: 146.5 mg/m³
Conclusion (systemic effects):
Worker DNEL long-term for oral or dermal route-systemic: 4.16 mg/kg bw/day
Worker DNEL long-term for inhalation exposure: 29.3 mg/m³
Worker DNELshort-term for oral or dermal route-systemic: 20.8 mg/kg bw/day
Worker DNEL short-term for inhalation exposure: 146.5 mg/m³
3.) Reproductive Toxicity – systemic effects (worker)
There was no fertility study with Vulkazon AFS (3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5,5]undecane) available. No effects on reproductive organs were observed in a 28 day study in rats. The pathologic evaluation consisted of organ weight, gross and microscopic examination of reproductive organs, incl. testes, epididymis, prostate gland, seminal vesicle, vagina, cervix, uterus, ovary, and oviduct. No treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination of all major organs (NOAEL, rat: 1000 mg/kg bw/day; males and females). On the basis of this study no effects on fertility were expected (NOAEL, rat: 1000 mg/kg bw/day).
In a OECD TG 414 study (pre-natal development toxicity study) in rats no adverse effects were reported and, consequently, the NOAEL for maternal, reproductive and developmental toxicity was found to be 1000 mg/kg/day (highest dose tested).
As no hazard for reproductive toxicity was reported the the NOAEL for reproductive toxicity (1000 mg/kg bw/day; highest dose tested) is higher than the NOAEL for repeated dose toxicity (300 mg/kg bw/day), the derivation of a separate DNEL for reproductive toxicity is not necessary, because the DNEL for repeated dose toxicity covers both endpoints.
4. Long-term and short-term dermal or inhalation route - local effects (worker)
In rabbits, Vulkazon AFS (3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5,5]undecane) is not irritating to the skin, and not irritating to the eyes. 5. Sensitization Vulkazon AFS (3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5,5]undecane) was not sensitising in a LLNA. Vulkazon AFS (3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5,5]undecane) is not sensitizing and not irritating to the skin and eyes. Therefore a DNEL for local effects is not applicable.
Conclusion (systemic and local effects - worker):
Route of exposureDNEL; local effectDNEL; systemic effect
Oral (long term) not applicable 4.16 mg/kg
Oral (short term) not applicable 20.8 mg/kg
Dermal (long term) not applicable 4.16 mg/kg
Dermal (short term) not applicable 20.8 mg/kg
Inhalation (long term) not applicable 29.3 mg/m³
Inhalation (short term) not applicable 146.5 mg/m³
References:
• Wirnitzer U, 3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5.5]undecane - Repeated Dose Systemic Toxicity Study in Wistar Rats (4-Weeks Daily Administration by Gavage) (draft), Bayer Pharma AG, GDD-GED General Toxicology, 42096 Wuppertal, Germany (2012)
•Loeser E, Kimmerle G, Ozonschutzmittel KAC 4196 - Akute toxikologische Untersuchungen, Bayer AG - Institut fuer Toxikologie, Wuppertal-Elberfeld, Germany, Report n° 6400, 1976
•Vohr HW, 3,9-Di-3-cyclohexen-1- yl-2,4,8,10-tetraoxaspiro (5.51 undecane - Local lymph node assay in mice (LLNA/IMDS Bayer Pharma AG - GDD-GED-Toxicology - 42096 Wuppertal, Germany, Report n° AT06363 (2012)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 mg/m³
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 260.8 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- see 'Discussion'
- AF for differences in duration of exposure:
- 6
- Justification:
- see 'Discussion'
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- see 'Discussion'
- AF for other interspecies differences:
- 1
- Justification:
- see 'Discussion'
- AF for intraspecies differences:
- 5
- Justification:
- see 'Discussion'
- AF for the quality of the whole database:
- 1
- Justification:
- see 'Discussion'
- AF for remaining uncertainties:
- 1
- Justification:
- see 'Discussion'
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 43.5 mg/m³
- Route of original study:
- Oral
DNEL related information
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/kg bw/day
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- see 'Discussion'
- AF for differences in duration of exposure:
- 6
- Justification:
- see 'Discussion'
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- see 'Discussion'
- AF for other interspecies differences:
- 1
- Justification:
- see 'Discussion'
- AF for intraspecies differences:
- 5
- Justification:
- see 'Discussion'
- AF for the quality of the whole database:
- 1
- Justification:
- see 'Discussion'
- AF for remaining uncertainties:
- 1
- Justification:
- see 'Discussion'
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 mg/kg bw/day
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Justification:
- see 'Discussion'
- Justification:
- see 'Discussion'
- Justification:
- see 'Discussion'
- Justification:
- see 'Discussion'
- Justification:
- see 'Discussion'
- Justification:
- see 'Discussion'
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/kg bw/day
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 mg/kg bw/day
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Vulkazon AFS (CAS 6600-31-3)
(3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5,5]undecane)
DNELs (general population)
Repeated dose toxicity
A subacute oral gavage study rats was evaluated for the derivation of DNELs of Vulkazon AFS.
Basis for delineation of the DNEL:
Study (rat study)
Repeated dose study
rat, male, female,
subacute oral gavage study for 28 days
rat: 0 (control), 100, 300 or 1000 mg/kg bw/d – male, female via gavage
NOEL = 300 mg/kg bw/d (male + female rats)
Effects, NOAEL
Effects:
Body weights were unaffected up to 300 mg/kg body weight in males and in all female dose groups. At 1000 mg/kg body weights of male rats were transiently significantly reduced.
The test item had no effect on food and water intake of all treated females and of low and mid dose males. High dose males consumed more food and water related to body weight.
Reference
Wirnitzer U (2012 draft)
Repeated Dose Systemic Toxicity Study in Wistar Rats (4-Weeks Daily Administration by Gavage)
Bayer Pharma AG
GDD-GED General Toxicology
42096 Wuppertal
Germany
Study n°: T3082698
1.) Long-term tocixity – systemic effects (general population)
Long-term oral or dermal route-systemic effects (general population) using default extrapolation factors:
NOEL(rat, male) from a subacute toxicity study: 300 mg/kg bw/day
Penetration oral compared to dermal: 1
For interspecies rat vs. human: 4
For remaining interspecies differences: 1*
For intraspecies differences in general population: 5**
For extrapolation of exposure duration subacute to chronic: 6
For reliability of dose-response: 1
For quality of whole database: 1
Overall factor: 120
DNEL long-term for oral or dermal route-systemic: 2.5 mg/kg bw/day
* An assessment factor of 1 is used for “remaining interspecies differences” because of the low absorption potential of the compound (see chapter toxicokinetic) and the low toxicity profile. Overall it is likely that bioavailability is very low and consequently toxicodynamic parameters are of minor significance.
** An assessment factor of 5 is used due because of the low absorption potential of the compound (see chapter toxicokinetic) and the low toxicity profile. Overall it is likely that bioavailability is very low and intraspecies differences in humans based on differences in human toxicokinetic and metabolism is of limited significance.
Long-term inhalation route-systemic effects (general population):
NOEL(rat) from a subacute toxicity study: 300 mg/kg bw/day
Correction of the starting point according TGD Figure R.8-3:
Corrected inhalatory NOEC = Oral NOEL (300 mg/kg) x 1/1.15 m³/kg x 1.0
=> NOEC worker = 260.8 mg/m³
For interspecies differences rat vs. human: 1 (according TGD Table
R.8-4. already covered by correction of starting point)
For remaining interspecies differences: 1*
For intraspecies differences in general population: 5**
For extrapolation of exposure duration subacute to chronic: 6
For reliability of dose-response: 1
For quality of whole database: 1
Overall factor: 30
DNEL long-term for inhalation exposure: 8.7 mg/m³
* An assessment factor of 1 is used for “remaining interspecies differences” because of the low absorption potential of the compound (see chapter toxicokinetic) and the low toxicity profile. Overall it is likely that bioavailability is very low and consequently toxicodynamic parameters are of minor significance.
** An assessment factor of 5 is used due because of the low absorption potential of the compound (see chapter toxicokinetic) and the low toxicity profile. Overall it is likely that bioavailability is very low and intraspecies differences in humans based on differences in human toxicokinetic and metabolism is of limited significance.
2.) Short-term toxicity – systemic effects (general population)
Concerning the systemic effects an exceeding factor of 5 based on the DNEL for long term exposure seems justified.
General population DNEL short-term for oral or dermal route-systemic: 12.5 mg/kg bw/day
General population DNEL short-term for inhalation exposure: 43.5 mg/m³
Conclusion (systemic effects):
General population DNEL long-term for oral or dermal route-systemic: 2.5 mg/kg bw/day
General population DNEL long-term for inhalation exposure: 8.7 mg/m³
General population DNEL short-term for oral or dermal route-systemic: 12.5 mg/kg bw/day
General population DNEL short-term for inhalation exposure: 43.5 mg/m³
3.) Reproductive Toxicity – systemic effects (worker)
There was no fertility study with Vulkazon AFS (3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5,5]undecane) available. No effects on reproductive organs were observed in a 28 day study in rats. The pathologic evaluation consisted of organ weight, gross and microscopic examination of reproductive organs, incl. testes, epididymis, prostate gland, seminal vesicle, vagina, cervix, uterus, ovary, and oviduct. No treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination of all major organs (NOAEL, rat: 1000 mg/kg bw/day; males and females). On the basis of this study no effects on fertility were expected (NOAEL, rat: 1000 mg/kg bw/day).
In a OECD TG 414 study (pre-natal development toxicity study) in rats no adverse effects were reported and, consequently, the NOAEL for maternal, reproductive and developmental toxicity was found to be 1000 mg/kg/day (highest dose tested).
As no hazard for reproductive toxicity was reported the the NOAEL for reproductive toxicity (1000 mg/kg bw/day; highest dose tested) is higher than the NOAEL for repeated dose toxicity (300 mg/kg bw/day), the derivation of a separate DNEL for reproductive toxicity is not necessary, because the DNEL for repeated dose toxicity covers both endpoints.
4. Long-term and short-term dermal or inhalation route - local effects (general population)
In rabbits, Vulkazon AFS (3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5,5]undecane) is not irritating to the skin, and not irritating to the eyes.
5. Sensitization
Vulkazon AFS (3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5,5]undecane) was not sensitising in a LLNA.
Vulkazon AFS (3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5,5]undecane) is not sensitizing and not irritating to the skin and eyes. Therefore no hazard was identified.
Conclusion (systemic and local effects – general population):
Route of exposure DNEL; local effect DNEL; systemic effect
Oral (long term) No hazard identified 2.5 mg/kg
Oral (short term) No hazard identified 12.5 mg/kg/day
Dermal (long term) No hazard identified 2.5 mg/kg
Dermal (short term) No hazard identified 12.5 mg/kg/day
Inhalation (long term) No hazard identified 8.7 mg/m³
Inhalation (short term) No hazard identified 43.5 mg/m³
References:
• Wirnitzer U, 3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5.5]undecane - Repeated Dose Systemic Toxicity Study in Wistar Rats (4-Weeks Daily Administration by Gavage) (draft), Bayer Pharma AG, GDD-GED General Toxicology, 42096 Wuppertal, Germany (2012)
• Loeser E, Kimmerle G, Ozonschutzmittel KAC 4196 - Akute toxikologische Untersuchungen, Bayer AG - Institut fuer Toxikologie, Wuppertal-Elberfeld, Germany, Report n° 6400, 1976
• Vohr HW, 3,9-Di-3-cyclohexen-1- yl-2,4,8,10-tetraoxaspiro (5.51 undecane - Local lymph node assay in mice (LLNA/IMDS Bayer Pharma AG - GDD-GED-Toxicology - 42096 Wuppertal, Germany, Report n° AT06363 (2012)
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