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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment report

Data source

Reference
Reference Type:
secondary source
Title:
SIDS Dossier
Author:
OECD SIDS
Year:
2008
Bibliographic source:
OECD HPV Chemical programme,SIDS Dossier, approved at SIAM 27 (14-17 October 2008)

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Principles of method if other than guideline:
Murine local lymph node assay was conducted on groups of mice at various concentrations on the dorsum of both ears for test chemical Nonanoyl Chloride (CAS no: 764-85-2) to determine its sensitization potential.
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Nonanoyl Chloride
Cas Number:
764-85-2
Molecular formula:
C9H17ClO
IUPAC Name:
Nonanoyl Chloride
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Nonanoyl chloride
- Molecular formula: C9H17ClO
- Molecular weight: 176.685 g/mol
- Substance type: organic
- Physical state: liquid
- Smiles: O=C(CCCCCCCC)Cl
- InChI: 1S/C9H17ClO/c1-2-3-4-5-6-7-8-9(10)11/h2-8H2,1H3
Specific details on test material used for the study:
- Name of test material (as cited in study report): Nonanoyl chloride
- Molecular formula: C9H17ClO
- Molecular weight: 176.685 g/mol
- Substance type: organic
- Physical state: liquid
- Smiles: O=C(CCCCCCCC)Cl
- InChI: 1S/C9H17ClO/c1-2-3-4-5-6-7-8-9(10)11/h2-8H2,1H3

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
Various concentration (5%, 10% and 15%)
No. of animals per dose:
3
Details on study design:
Nonanoyl chloride in acetone /olive oil was applied to groups of mice for 3 consecutive days in various concentrations on the dorsum of both ears. On day 5 after the first application mice are injected intravenously with [³H]thymidine. Subsequently [³H]thymidine activity was measured as a function of isotope incorporation in the draining atricular lymph nodes.
Positive control substance(s):
not specified
Statistics:
Chemicals, which provoke at least in one concentration, a 3-fold or greater increase in isotope incorporation compared with the vehicle controls are classified as potential sensitizers.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
other: T/C ratio
Value:
12.7
Test group / Remarks:
at 5% concentration
Remarks on result:
other: sensitizing
Parameter:
other: T/C ratio
Value:
19.4
Test group / Remarks:
at 10% concentration
Remarks on result:
other: sensitizing
Parameter:
other: T/C ratio
Value:
20.9
Test group / Remarks:
at 25% concentration
Remarks on result:
other: sensitizing
Cellular proliferation data / Observations:
Nonanoyl chloride revealed sensitizing properties in this test.

Any other information on results incl. tables

% Concentration

5

10

25

T/C ratio

12.7

19.4

20.9

Applicant's summary and conclusion

Interpretation of results:
other: sensitizing
Conclusions:
The test material Nonanoyl Chloride (CAS no: 764-85-2) was considered to be sensitizing in the Murine local lymph node assay performed according to OECD 429 Guideline.
Executive summary:

Murine local lymph node assay was conducted on groups of mice at various concentrations on the dorsum of both ears for test chemical Nonanoyl Chloride (CAS no: 764-85-2) to determine its sensitization potential in accordance with OECD 429 Guideline.

 

Nonanoyl chloride in acetone /olive oil was applied to groups of mice for 3 consecutive days in various concentrations on the dorsum of both ears. On day 5 after the first application mice are injected intravenously with [³H]thymidine. Subsequently [³H]thymidine activity was measured as a function of isotope incorporation in the draining atricular lymph nodes. Chemicals, which provoke at least in one concentration, a 3-fold or greater increase in isotope incorporation compared with the vehicle controls are classified as potential sensitizers.

 

Since the chemicalNonanoyl chloride (CAS no: 764-85-2) revealed sensitizing properties in this test, it was considered to be sensitizing in the Murine local lymph node assay.