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Toxicological information

Skin sensitisation

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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:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
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 lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

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.