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Administrative data

Description of key information

An experimental study conducted  by Tetsuo Yamano et al.( Toxicology , 2007) on target substance2,3,5 trimethylphenols (697-82-5) on mice. LLNA test was conducted on male BALB/cA mice for 2,3,5 trimethylphenols (697-82-5) . On 3 consecutive days the groups of 3 mice were exposed to at 25 µl of 1M of chemical. Acetone/ olive oil, 4:1 were used as a vehicle. Three or five days after the last application, a pair of auricular lymph nodes (LNs) from each mouse was excised for the LLNA. A stimulation index was calculated as the ratio of the BrdU amount in the lymph nodes of chemical-treated mice to that of vehicle-treated mice. Stimulation index variation was observed as 0 for the test chemical.From experiment it was concluded that the 2,3,5Trimethylphenol (697-82-5) was considered to be non-sensitizing in mice LLNA assay.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Mouse local lymphnode assay (LLNA) was used to determined skin sensitization potential of 2,3,5Trimethylphenol in mice.
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2,3,5Trimethylphenol
- Molecular formula (if other than submission substance): C9H12O
- Molecular weight (if other than submission substance): 136.193 g/mol
- Substance type: Organic
- Physical state: Solid
Species:
mouse
Strain:
other: BALB/cA mice
Sex:
male
Details on test animals and environmental conditions:
Details on test animal
TEST ANIMALS
- Source: CLEA Japan (Tokyo, Japan)
- Age at study initiation: Six- to eight-week-old
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
Vehicle:
other: acetone/ olive oil, 4:1, AOO
Concentration:
25 µl of 1M of 2,3,5 trimethylphenols
No. of animals per dose:
3 mice
Details on study design:
TREATMENT PREPARATION AND ADMINISTRATION: Groups of three mice were exposed to 25 µl of 1M methylphenols, 0.3% DNCB, 3% TMA, or vehicle (acetone/ olive oil, 4:1, AOO) through application to the dorsum of both ears for 3 consecutive days. Three or five days after the last application, a pair of auricular lymph nodes (LNs) from each mouse was excised for the LLNA

Positive control substance(s):
not specified
Statistics:
The values for each chemical-treated group and vehicle group (control group) were compared via Dunnett’s or Steel’s multiple comparison method using a StatLight software package

In stimulation index was calculated as the ratio of the BrdU amount in the lymph nodes of chemical-treated mice to that of vehicle-treated mice.
Key result
Parameter:
SI
Value:
0 - 0
Variability:
1-12
Test group / Remarks:
Stimulation index result was zero for the test group.
Remarks on result:
other: No indication of skin sensitization .
Cellular proliferation data / Observations:
Yes

No indication of skin sensitization .

Interpretation of results:
other: not sensitizing
Conclusions:
Skin sensitization test was observed for 2,3,5 trimethylphenols (697-82-5) in BALB/cA mice by LLNA method.The test result for 2,3,5Trimethylphenol (697-82-5) was in LLNA assay.

Executive summary:

LLNA test was conducted on male BALB/cA mice for 2,3,5 trimethylphenols (697-82-5) . On 3 consecutive days the groups of 3 mice were exposed to at 25 µl of 1M of chemical. Acetone/ olive oil, 4:1 were used as a vehicle. Three or five days after the last application, a pair of auricular lymph nodes (LNs) from each mouse was excised for the LLNA. A stimulation index was calculated as the ratio of the BrdU amount in the lymph nodes of chemical-treated mice to that of vehicle-treated mice. Stimulation index variation was observed as 0 for the test chemical.From experiment it was concluded that the 2,3,5Trimethylphenol (697-82-5) was considered to be non-sensitizing in mice LLNA assay.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization

In different studies, 2,3,5 trimethylphenols (697-82-5) has been investigated for potential for dermal sensitization to a greater or lesser extent. The study is based on in vivo experiments in mice by LLNA method for target chemical2,3,5 trimethylphenols (697-82-5). The target experimental data has also been supported with predicted data using the OECD QSAR toolbox.

A key experimental study conducted  by Tetsuo Yamano et al.( Toxicology , 2007) on target substance2,3,5 trimethylphenols (697-82-5) on mice. LLNA test was conducted on male BALB/cA mice for 2,3,5 trimethylphenols (697-82-5) . On 3 consecutive days the groups of 3 mice were exposed to at 25 µl of 1M of chemical. Acetone/ olive oil, 4:1 were used as a vehicle. Three or five days after the last application, a pair of auricular lymph nodes (LNs) from each mouse was excised for the LLNA. A stimulation index was calculated as the ratio of the BrdU amount in the lymph nodes of chemical-treated mice to that of vehicle-treated mice. Stimulation index variation was observed as 0 for the test chemical.From experiment it was concluded that the 2,3,5Trimethylphenol (697-82-5) was considered to be non-sensitizing in mice LLNA assay.

The skin sensitization potential of 2,3,5 trimethylphenols (697-82-5) was estimated by SSS (2017) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor and considering the six closest read across substances. 2,3,5 trimethylphenols (697-82-5) was predicted to be non sensitizing to the skin of Hartley strain and Hartley-English short hair cross-strain guinea pig.

 

Thus based on the experimental study and prediction on 2,3,5 trimethylphenols (697-82-5) , it can be concluded that 2,3,5 trimethylphenols is not a skin sensitizer. Thus comparing the above annotations with the criteria of CLP regulation, 2,3,5 trimethylphenols (697-82-5) can be considered as not classified for skin sensitization effects.

Justification for classification or non-classification

Thus comparing the above annotations with the criteria of CLP regulation, 2,3,5 trimethylphenols (697-82-5) can be considered as not classified for skin sensitization effects