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EC number: 288-284-4 | CAS number: 85711-26-8
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 March 1981 to 03 April 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (only 10 animals/group; absolute ethanol used as vehicle; possibly the highest non-irritant concentration may not have been used; positive control response ambiguous)
- GLP compliance:
- yes
- Remarks:
- Deviation from GLP regulations: No retain was obtained of the vehicle control, absolute ethanol (USP)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler/Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for fatty alcohols. Please refer to the attached document for further details.
Test material
- Reference substance name:
- Alcohols, C9-11-branched and linear
- EC Number:
- 288-284-4
- EC Name:
- Alcohols, C9-11-branched and linear
- Cas Number:
- 85711-26-8
- Molecular formula:
- C9H20O, C10H22O and C11H24O
- IUPAC Name:
- Alcohols, C9-11-branched and linear
- Reference substance name:
- C9-11 alcohols
- IUPAC Name:
- C9-11 alcohols
- Test material form:
- liquid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Camm Research Laboratories, Wayne, New Jersey, USA
- Age at study initiation: no data
- Weight at study initiation: 529 - 561 g (group means)
- Housing: Stainless steel cages, 5 animals per cage
- Diet (e.g. ad libitum): Purina Lab Guinea Pig Chow 5025, ad libitum
- Water (e.g. ad libitum): Tap water, Edstrom automatic watering system, ad libitum
- Acclimation period: at least 13 days; up to 20 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 22.5 (range 21.7 - 23.9)
- Humidity (%): average 49.6 (range 30-60)
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- Induction and challenge: 1.01%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- Induction and challenge: 1.01%
- No. of animals per dose:
- 10 (5 males, 5 females); applies to all groups
- Details on study design:
- RANGE FINDING TESTS:
1 animal/sex was treated epicutaneously (at two sites) with 1, 50 or 100% Neodol 91 (where applicable dissolved in absolute ethanol) under occlusion for 6 hours. Only the 1% solution did not elicit a reaction indicative of irritation.
MAIN STUDY - Non-adjuvant Buehler test
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 3 weeks
- Test groups: 1
- Control group: 2 (vehicle and positive controls)
- Site: back/trunk
- Frequency of applications: one day/week, on 3 consecutive weeks
- Duration: 6 hours
- Concentrations: 1.01 % (volume 0.5 ml)
- Reactions were scored approximately 24 and 48 hours after treatment (Draize grading system)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28 (i.e. 2 weeks after final induction)
- Exposure period: 6 hours
- Test groups: 1
- Control group: 3 (vehicle, positive and irritation controls)
- Site: back/trunk (two patches, on sensitized and virgin application sites)
- Concentrations: 1.01% (volume 0.5 ml)
- Evaluation (hr after challenge): 24 and 48 (Draize grading system)
No rechallenge.
OTHER: Exposure sites were shaved (48 hours) and depilated (24 hours) prior to exposure.
Each treatment involved dispensing the appropriate dose on a 1"x1" gauze pad attached to a 2" wide strip of Blenderm (R) surgical tape (Minnesota mining and Manufacturing, Saint Paul, Minnesota), then applying the patch to the anterior central portion of the back/trunk and securing with Saran wrap (Dow Chemical co., Indianapolis, Indiana). Animals were placed in a stainless steel wire restrained for the six-hour application duration for the first and second applications (for the 3rd and challenge applications, they had outgrown the restrainers and so these were not used; nevertheless the patches and wraps remained in situ). Excess test material was removed with a moistened gauze pad. - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitrochlorobenzene (0.1% solution in diethyl ether)
Results and discussion
- Positive control results:
- The positive controls showed a significant response at challenge with all test sites showing an increased degree of irritation. However, reactions were similar to those seen during induction and so were not unambiguously indicative of sensitization.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- "Barely perceptible" redness at original site (i.e. induction site) in 6/10 animals (indicative of mild irritation); no reactions at challenge site
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Reactions were similar to those seen during induction and so were not unambiguously indicative of sensitization.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% DNCB
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Clinical observations:
- One animal died (not treatment related). Reactions were similar to those seen during induction and so were not unambiguously indicative of sensitization.
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
RESULTS OF TEST
There was slight irritation in the test group during the induction period. The average Draize score was 0.38 at week 1, 0.5 at week 2 and 0.28 at week 3. By week 5 the score was zero (no irritation seen).
Average irritation at challenge for the treated group was 0, positive controls were 1.55, vehicle controls 0.08 and irritation controls
(challenge application only) 0.13.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vivo skin sensitisation study, conducted according to a protocol similar to OECD Test Guideline 406 and in compliance with GLP, Alcohols, C9-11-branched and linear (1% in ethanol) was not sensitising to the skin of guinea pigs when tested using the Buehler non-adjuvant method.
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