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EC number: 203-897-9 | CAS number: 111-70-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 May 2011 - 22 July 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guidelines; adequate coherence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- two animals were evaluated for skin reactions at 44.25h after removal of dressing instead of 48h
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- idem above
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A magnusson and Kligman was performed in order to verify the result obtained in the LLNA study as it is a maximization test..
Test material
- Reference substance name:
- Heptan-1-ol
- EC Number:
- 203-897-9
- EC Name:
- Heptan-1-ol
- Cas Number:
- 111-70-6
- Molecular formula:
- C7H16O
- IUPAC Name:
- heptan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): N-HEPTANOL
- Physical state: colorless liquid
- Analytical purity: 99.73%
- Lot/batch No.: 1103016
- Expiration date of the lot/batch: 09 December 2011
- Storage conditions of test material: at room temperature, well-ventilated place.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Charles River Laboratories France, L’Arbresle, France
- Age at study initiation: at the beginning of the treatment period, the animals of the main test were 1-2 months old
- Weight at study initiation: 307 g ± 10 g for the males and 304 g ± 10 g for the females
- Housing: individually housed in polycarbonate cages with stainless steel lid
- Diet (e.g. ad libitum): free access to 106 pelleted diet
- Water (e.g. ad libitum): tap water (filtered with a 0.22 µm filter)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h (7:00 - 19:00).
IN-LIFE DATES: From: 07 June 2011 To: 22 July 2011
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: corn oil (intradermal); ethanol/drinking water (topical induction); acetone (topical challenge)
- Concentration / amount:
- 1% intradermal, 100% topical induction, 10% topical challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: corn oil (intradermal); ethanol/drinking water (topical induction); acetone (topical challenge)
- Concentration / amount:
- 1% intradermal, 100% topical induction, 10% topical challenge
- No. of animals per dose:
- in treated groups of main test:
10 males and 10 females - Details on study design:
- RANGE FINDING TESTS:
Performed to determine maximum concentrations tested in the main test
MAIN STUDY
See executive summary - Challenge controls:
- left flank: vehicle only
- Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% (challenge)
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% (challenge). No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: discrete erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% (challenge)
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema; dryness of skin
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% (challenge). No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: discrete erythema; dryness of skin.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item did not induce delayed contact hypersensitivity in guinea pigs.
- Executive summary:
The objective of this study was to evaluate the potential of the test item, n-HEPTANOL (batch No. 1103016), to induce delayed contact hypersensitivity in guinea pigs.
This study was conducted in compliance with the principles of Good Laboratory Practice.
Methods
A preliminary test was first performed in order to determine the test item concentrations to be used in the main test.
In the main test, one group of 10 males and 10 females received the test item:
. on day 1 by intradermal injections in the interscapular region at the concentration of 1%,
. on day 8 by topical application to the clipped interscapular region at 100%,
. on day 22 by topical application to the posterior right flank at 10%. The posterior left flank of the animals received the vehicle.
Another control group of five males and five females received the vehicles:
. corn oil on day 1 in the interscapular region,
. drinking water treated by reverse osmosis on day 8 in the interscapular region,
. acetone on day 22 to the posterior left flank. The posterior right flank of animals received the test item at 10%.
On day 1, three pairs of intradermal injections were performed in the interscapular region of animals:
. Freund's complete adjuvant (FCA) diluted to 50% (v/v) with 0.9% NaCl,
. test item in vehicle or vehicle alone,
. test item in FCA/0.9% NaCl (50/50, w/w) or vehicle at 50% (w/v) in FCA/0.9% NaCl (50/50, v/v).
On day 8, a filter paper (approximately 8 cm2) was fully-loaded with the dosage forms and then applied to the clipped interscapular region, over the intradermal injection sites. The filter paper was held in place by means of an occlusive dressing for 48 hours. The presence of local irritation was checked (but not scored).
The induction phase was followed by a 14-day rest period.
On day 22, a Finn Chamber filter paper was fully-loaded with the dosage forms. The chamber was held in contact with the skin by an occlusive dressing for 24 hours. Cutaneous reactions were evaluated before treatment and 24 and 48 hours after removal of the dressing.
Each animal was observed at least once a day for mortality and clinical signs during the treatment and observation periods. Body weight was recorded on day 1 and at the end of each observation period.
On completion of the observation period, the animals were sacrificed then discarded without macroscopic post-mortem examination. No skin samples were preserved.
Results
After the challenge application, in the control group, at the 24-hour reading, a discrete erythema was observed at right flank treated with test item of 1/10 animals. At the 48-hour reading, a discrete erythema was observed at left flank treated with vehicle of 1/10 animals.
In the test item-treated group, at the 24-hour reading, a discrete erythema was noted at right flank treated with test item of 1/20 animals.
At the 48-hour reading, a discrete erythema was observed at left flank treated with vehicle of 1/20 animals and at right flank treated with test item of 4/20 animals. In addition, dryness of the skin was noted at right flank of 1/20 animals.
As the cutaneous reactions were similar at right flank treated with test item and at left flank treated with vehicle, they were considered not to be attributed to delayed contact hypersensitivity.
Conclusion
The test item did not induce delayed contact hypersensitivity in guinea pigs.
Therefore, the test item should not be considered as sensitizing.
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