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EC number: 814-059-2 | CAS number: 68680-98-8
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: equivalent to current guidelines, according to GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: equivalent to current guidelines, according to GLP
- Justification for type of information:
- See read-across justification attached in section 13.2
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- alternative parameters used
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/JICO
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 9 weeks
- Weight at study initiation: 19.5 g - 25.0 g
- Housing: single housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- propylene glycol
- Concentration:
- 10, 30, and 60 %
- No. of animals per dose:
- 6
- Details on study design:
- - Criteria used to consider a positive response:
lf a test substance does not show a statistically significant increase in ceII count and/or lymph node weight as compared to the vehicle control in the presence of statistically significantly increased ear weights as indication of skin irritation, it is considered not to be a sensitizer.
lf at least one concentration tested causes a concentration dependent statistically significant increase in cell count and/or lymph node weight without being accompanied by a statistically significant increase in ear weight, the test substance is considered to be a sensitizer.
lf statistically significant increases in ear weights are running in parallel to the increase in ceII count and/or lymph node weight, it cannot be ruled out, that the lymph node response was caused by irritation and not by skin sensitization. Then, for identification of the relevance of the statistical evaluation, a comparison of the results of the present test to appropriate historical control values is performed. lt one or a combination of the measured parameters change statistical significance, evaluation on basis of the criteria described above may be possible. lf the statistical comparison with
the historical control does not yield results useful tor evaluation, further investigations may be necessary to differentiate between irritation and sensitization response.
lf a test substance does not elicit a statistical significant increase in lymph node weight and/or cell count but shows a clear concentration related increase in response, further investigating of the sensitization potential at higher concentrations would be considered. - Positive control substance(s):
- other: Historical control: Alpha-Hexylcinnamaldehyde
- Statistics:
- WILCOXON-test
- Parameter:
- SI
- Test group / Remarks:
- untreated
- Remarks on result:
- other: see Remark
- Remarks:
- Lymphnode weight Index: untreated: 0.89 Cell count index: untreated: 0.89 Ear weight index: untreated: 0.97
- Parameter:
- SI
- Test group / Remarks:
- vehicle
- Remarks on result:
- other: Lymphnode weight Index: vehicle: 1 Cell count index: vehicle: 1 Ear weight index: vehicle: 1
- Parameter:
- SI
- Test group / Remarks:
- 10 %
- Remarks on result:
- other: Lymphnode weight Index: 10% TS: 0.95 Cell count index: 10% TS: 1.05 Ear weight index: 10% TS: 1.06
- Parameter:
- SI
- Test group / Remarks:
- 30 %
- Remarks on result:
- other: Lymphnode weight Index: 30% TS: 0.87 Cell count index: 30% TS: 0.92 Ear weight index: 30% TS: 1.08* *for p<=0.05
- Parameter:
- SI
- Test group / Remarks:
- 60 %
- Remarks on result:
- other: Lymphnode weight Index: 60% TS: 0.76 Cell count index: 60% TS: 0.88 Ear weight index: 60% TS: 1.04
No signs of systemic toxicity were noticed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- alternative parameters used
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Nonane-1,9-diol
- EC Number:
- 223-517-5
- EC Name:
- Nonane-1,9-diol
- Cas Number:
- 3937-56-2
- Molecular formula:
- C9H20O2
- IUPAC Name:
- nonane-1,9-diol
- Details on test material:
- - Name of test material (as cited in study report): 1,9-Nonandiol
- Physical state: Crystalline / white at room temperature; Liquid / white after heating at about 80 - 100°C
- Analytical purity: 98.8 cor. area%
- Lot/batch No.: 42638
- Stability under test conditions: The stability under storage conditions was confirmed by reanalysis.
- Storage condition of test material: Room temperature, exclusion of oxygen (storage under nitrogen)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/JICO
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 9 weeks
- Weight at study initiation: 19.5 g - 25.0 g
- Housing: single housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 10, 30, and 60 %
- No. of animals per dose:
- 6
- Details on study design:
- - Criteria used to consider a positive response:
lf a test substance does not show a statistically significant increase in ceII count and/or lymph node weight as compared to the vehicle control in the presence of statistically significantly increased ear weights as indication of skin irritation, it is considered not to be a sensitizer.
lf at least one concentration tested causes a concentration dependent statistically significant increase in cell count and/or lymph node weight without being accompanied by a statistically significant increase in ear weight, the test substance is considered to be a sensitizer.
lf statistically significant increases in ear weights are running in parallel to the increase in ceII count and/or lymph node weight, it cannot be ruled out, that the lymph node response was caused by irritation and not by skin sensitization. Then, for identification of the relevance of the statistical evaluation, a comparison of the results of the present test to appropriate historical control values is performed. lt one or a combination of the measured parameters change statistical significance, evaluation on basis of the criteria described above may be possible. lf the statistical comparison with
the historical control does not yield results useful tor evaluation, further investigations may be necessary to differentiate between irritation and sensitization response.
lf a test substance does not elicit a statistical significant increase in lymph node weight and/or cell count but shows a clear concentration related increase in response, further investigating of the sensitization potential at higher concentrations would be considered. - Positive control substance(s):
- other: Historical control: Alpha-Hexylcinnamaldehyde
- Statistics:
- WILCOXON-test
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Test group / Remarks:
- untreated
- Remarks on result:
- other: see Remark
- Remarks:
- Lymphnode weight Index: untreated: 0.89 Cell count index: untreated: 0.89 Ear weight index: untreated: 0.97 Lymphnode weight Index: untreated: 0.89 Cell count index: untreated: 0.89 Ear weight index: untreated: 0.97
- Parameter:
- SI
- Test group / Remarks:
- vehicle
- Remarks on result:
- other: Lymphnode weight Index: vehicle: 1 Cell count index: vehicle: 1 Ear weight index: vehicle: 1
- Parameter:
- SI
- Test group / Remarks:
- 10 %
- Remarks on result:
- other: Lymphnode weight Index: 10% TS: 0.95 Cell count index: 10% TS: 1.05 Ear weight index: 10% TS: 1.06
- Parameter:
- SI
- Test group / Remarks:
- 30 %
- Remarks on result:
- other: Lymphnode weight Index: 30% TS: 0.87 Cell count index: 30% TS: 0.92 Ear weight index: 30% TS: 1.08* *for p<=0.05
- Parameter:
- SI
- Test group / Remarks:
- 60 %
- Remarks on result:
- other: Lymphnode weight Index: 60% TS: 0.76 Cell count index: 60% TS: 0.88 Ear weight index: 60% TS: 1.04
Any other information on results incl. tables
No signs of systemic toxicity were noticed.
Applicant's summary and conclusion
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