Registration Dossier
Registration Dossier
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EC number: 271-832-1 | CAS number: 68609-68-7 The complex combination of products produced by the distillation of products from a 2-ethyl-1-hexanol manufacturing process. It consists predominantly of organic compounds such as alcohols, aldehydes, esters, carboxylic acids and acetals having carbon numbers predominantly in the range of C4 through C16 and boiling in the range of 150°C to 308°C (302°F to 586°F).
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The OECD Test Guideline for LLNA was not available at time of study implementation. Existing data from GPMT study scientifically adequate.
Test material
- Reference substance name:
- 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues
- EC Number:
- 271-832-1
- EC Name:
- 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues
- Cas Number:
- 68609-68-7
- Molecular formula:
- UVCB, not applicable, see section 1.2 for information on constituents
- IUPAC Name:
- 2,4-diethyl-3-propylpentane-1,5-diol; 2,4-diethyloctan-1-ol; 2-ethylhexan-1-ol; 2-ethylhexane-1,3-diol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Stolzenseeweg 32, 88353 Kissleg, Germany
- Age at study initiation: young adult
- Weight at study initiation: 345-366 g
- Housing: Macrolon type-III cages with 2-3 animals/cage
- Diet: Purina Base - Lap gr diet for rabbit (Agribrands Europe Hungary PLC, H-5300 Karcag, Madarasi Road, Hungary), ad libitum; suitable for guinea pigs and also used by the breeder
- Water: tap water with ascorbic acid 0.5 mg/mL, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Air changes: 15-20 air changes/hour
- Photoperiod: 12 hours dark / 12 hours light
IN-LIFE DATES: From: 30-Sep-2009 To: 25-Oct-2009
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Sesame oil
- Concentration / amount:
- Intradermal induction exposure: 5 %
Dermal induction exposure: 100 %
Challenge exposure: 25 % (with 12.5 % applied on the other flank of each animal as safeguard dose)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sesame oil
- Concentration / amount:
- Intradermal induction exposure: 5 %
Dermal induction exposure: 100 %
Challenge exposure: 25 % (with 12.5 % applied on the other flank of each animal as safeguard dose)
- No. of animals per dose:
- 10 test animals, 5 control animals
- Details on study design:
- RANGE FINDING TESTS:
For the intra-dermal application, 0.1 mL of formulated test item was injected at concentrations of 0.01, 0.1, 1.0, 5.0, 10 and 25 % (all w/v) into the hair free skin. The treated areas were covered for 24 hours with porous gauze fastened with "Clinipore-silk". For the dermal application, animals pre-treated with Freund’s Adjuvant were used. On day 1, each animal received 2 injections of 0.1 mL Freund's Adjuvant mixed with physiological saline (1:1 v/v). On day 8, 0.5 mL per concentration (25, 50, 75 (all w/v) and 100 %) was applied onto hair free skin of the animals. A closed patch exposure was applied by means of an occlusive bandage
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal
- No. of exposures: 1
- Exposure time: day 1 (6 injections/animal)
- Test groups: 1
- Control group: 1
- Site: dorsal, flank
- Frequency of applications: single application
- Concentration: 5 % (w/v)
Dermal
- No. of exposures: 1
- Exposure time and duration: day 8 (closed patch), for 48 hours
- Site: dorsal, flank
- Frequency of applications: single application
- Concentration: 100 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 22
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: dorsal, flank
- Concentration: 25 % (with 12.5 % applied on the other flank of each test animal as safeguard dose)
- Evaluation: Magnusson and Kligman grading scale
The sensitivity and reliability of the experimental procedure was assessed by use of the reference item 2 -Mercaptobenzothiazole under LAB Research Ltd. study number 09/141 -104T (29-Jun-2009 to 24-Jul-2009). - Challenge controls:
- Control animals were treated similarly to test animals, except that during the induction phase the test item was omitted.
- Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- See "Any other information on results incl. tables"
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- peeling of the skin in 6/10 animals
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- See "Any other information on results incl. tables"
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 12.5 % (safeguard dose)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 12.5 % (safeguard dose)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12.5 % (safeguard dose)
- 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:
- 72
- Group:
- test chemical
- Dose level:
- 12.5 % (safeguard dose)
- 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:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Challenge with a concentration of 25 % resulted in barely perceptible erythema in 7/10 test animals at 24 hours, which persisted to 48 hours in 2/10 animals only. The mean of the scores were 0.70 (70 % responders) and 0.20 (20 % responders) according to the 24 and 48 hour observations. No signs of skin reaction were noted in control animals (0/5) or in test animals following treatment with the safeguard concentration of 12.5 % (0/10).
Since for an immune response it would be expected that under the conditions of this study
(i) many animals treated with the challenge dose would have a reaction persisting to 48 hours,
(ii) there would be at least some animals with a grade 2 or 3 response at 24 hours after treatment with the challenge dose, and
(iii) treatment with the safeguard dose (corresponding to 50 % of the challenge dose) would give some response
the observed transient biological response (barely perceptible erythema in 70 % of the animals at 24 hours) was considered not to represent an immune reaction.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In conclusion, under the conditions of the present assay the test item was considered not to have a sensitisation potential and classified as a non-sensitiser, based on this guinea pig maximisation test and according to current EU-regulations.
- Executive summary:
In a dermal sensitisation study (Török-Batho, 2010) with 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues (≥98 %) in sesame oil, young adult Hartley guinea pigs (test group: 10 males, control group: 5 males) were tested using the guinea pig maximisation test of Magnusson and Kligman. Challenge with the test item resulted in a mean score of 0.70 (7/10) and 0.20 (2/10) at the 48 and 72 hour observations (24 and 48 hours after patch removal), respectively. The net response value was 70 %, as barely perceptible erythema at the first observation. However, the net response value at the second observation was only 20 %. No signs of skin reaction were noted following treatment with the safeguard concentration (corresponding to 50 % of the challenge concentration). Since for an immune response it would be expected that under the conditions of this study many animals treated with the challenge dose would have a reaction persisting to the second observation, there would be at least some animals with a grade 2 or 3 response at the first observation after challenge, and treatment with the safeguard dose would give some response, the observed transient biological response (barely perceptible erythema in 70 % of the animals at 48 hours) was considered not to represent an immune reaction.
In this study, 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues was not a skin sensitiser.
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