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EC number: 812-526-5 | CAS number: 53831-80-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005 - from collection of data, only completed year noted.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Considering the structural similarities of both molecules and the probability to act via a common mode of action, it is acceptable to utilise EC 209-711-2 as a read-across source. See attached document for full justification.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Remarks:
- Endpoint from collected of data and compliance details are not available.
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-aminophenol
- EC Number:
- 209-711-2
- EC Name:
- 3-aminophenol
- Cas Number:
- 591-27-5
- Molecular formula:
- C6H7NO
- IUPAC Name:
- 3-aminophenol
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- 28 females allocated to 7 groups of 4 animals
Environmental conditions not specified (data from collection of informaiton)
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Concentrations up to 25% (1, 2.5, 5, 10 and 25%) for inital dose.
Concentrations up to 2.5% for followup dose (0.05, 0.1, 0.5, 1, 2.5%) - No. of animals per dose:
- 4
- Details on study design:
- 28 females allocated to 7 groups of 4 animals
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Stimilation Index was 4.11 for initial exposure to 25% alpha-hexylcinnamaldehyde in dimethylformamide. This increased to 5.77 during the seondary exposure to 25% alpha-hexylcinnamaldehyde in dimethylformamide.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- ca. 0.24
- Variability:
- Not specified
- Test group / Remarks:
- The EC3 value (0.24%) indicated a strong sensitisation potential for m-aminophenol.
- Key result
- Parameter:
- SI
- Value:
- 1.04
- Test group / Remarks:
- 0.05% re-expoure
- Key result
- Parameter:
- SI
- Value:
- 1.41
- Test group / Remarks:
- 0.1% re-exposure
- Key result
- Parameter:
- SI
- Value:
- 5.88
- Test group / Remarks:
- 0.5% re-exposure
- Key result
- Parameter:
- SI
- Value:
- 9
- Test group / Remarks:
- 1% re-exposure
- Key result
- Parameter:
- SI
- Value:
- 11.01
- Test group / Remarks:
- 2.5% re-exposure
- Cellular proliferation data / Observations:
- Comment
m-Aminophenol induced contact sensitisation in a murine Local Lymph Node Assay and was
rated to have a strong sensitisation potential.
Any other information on results incl. tables
Comment
m-Aminophenol induced contact sensitisation in a murine Local Lymph Node Assay and was
rated to have a strong sensitisation potential.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- m-Aminophenol induced contact sensitisation in a murine Local Lymph Node Assay and was rated to have a strong sensitisation potential.
Classified as Category 1 for skin sensitisation potential according to EC 1272/2008. - Executive summary:
A Local Lymph Node Assay was conducted in female CBA/J mice to investigate the sensitisation potential of m-aminophenol. Concentrations up to 25% (the maximum soluble concentration) in dimethylformamide were tested in two successive experiments. A positive control group received 25% alpha-hexylcinnamaldehyde in dimethylformamide. No mortality, clinical signs or body weight changes could be attributed to compound administration. An increase in stimulation index was observed with increasing dose and the threshold positive value of 3 was exceeded at concentrations of 0.5% and higher.
m-Aminophenol induced contact sensitisation in a murine Local Lymph Node Assay and was rated to have a strong sensitisation potential.
Classified as Category 1 for skin sensitisation potential according to EC 1272/2008.
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