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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
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Solubility in organic solvents / fat solubility
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- Auto flammability
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- Endpoint summary
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- Environmental data
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
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- Specific investigations
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
In the key 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 (Shell, 1981c).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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.
- 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 - Route:
- epicutaneous, occlusive
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- Induction and challenge: 1.01%
- 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)
- 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.
- 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
- 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
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 (Shell, 1981c).
During epicutaneous induction, the test material was diluted in absolute ethanol to concentration of 1.01 % and applied onto the skin under occlusive dressing for 6 hours. Skin reactions were assessed at 24 and 48 hours post-exposure. The epicutaneous induction was repeated 3 times in three consecutive weeks.
During challenge, which was conducted two weeks after the last induction, the test material was diluted in absolute ethanol to achieve concentration of 1.01 %. The test item was applied onto the skin under occlusive dressing for 6 hours and skin reactions were assessed at 24 and 48 hours post-exposure. No skin reactions were seen in the test group but the guideline requirement for the use of the highest non-irritating concentration may not have been achieved since the next highest concentration tested in the pre-screen, which produced irritation, was 50 %. The positive control gave an ambiguous sensitisation response.
The conclusion of the key study is supported by the in vivo skin sensitisation study for the analogue Alcohols, C9-11. The study was conducted according to a protocol similar to OECD Test Guideline 406, but prior to GLP and concluded Alcohols, C9-11 to be not a skin sensitiser in guinea pigs after a topical challenge with 5% test item (Shell, 1978). Corn oil was used as the vehicle for the test material and induction applications were 0.1 % intradermal and 10 % occlusive epicutaneous. Challenge application was 5 % occlusive epicutaneous. No skin reactions were seen after challenge.
Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:
There is evidence throughout the carbon number range C6-C24 that long chain alcohols are not sensitising; this conclusion does not vary with carbon number within the Category: read-across substances are chosen based on carbon chain length and similarity of physicochemical properties.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
The test material contains no structural groups suggestive of respiratory sensitisation and, together with the lack of skin sensitising potential, it is unlikely to be a respiratory sensitiser.
Justification for classification or non-classification
Based on the available data, Alcohols C9-11 linear and branched would not be classified as a skin or respiratory sensitiser according to Regulation (EC) No. 1272/2008 . Tests on similar substances included in this category are also supportive of these results, which do not warrant classification for sensitisation under DSD or GHS criteria.
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