Registration Dossier
Registration Dossier
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EC number: 208-395-3 | CAS number: 526-75-0
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- 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 peer-reviewed journal
- Objective of study:
- metabolism
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- In Vivo metabolism study of 2,3-dimethylphenol in rabbit
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2,3-dimethylphenol
- Molecular formula (if other than submission substance): C8H10O
- Molecular weight (if other than submission substance): 122.166 g/mole
- Substance type: Organic
- Physical state: No data available
- Impurities (identity and concentrations): No data available - Radiolabelling:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation:No data available
- Weight at study initiation: 2-3 kg.
- Fasting period before study:No data available
- Housing:No data available
- Diet (e.g. ad libitum): rabbit pellets, ad libitum
- Water (e.g. ad libitum):Water, ad libitum
- 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
IN-LIFE DATES: From: To:No data available - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- 2,3-dimethylphenol were administered by stomach tube as suspensions in water.
- Duration and frequency of treatment / exposure:
- No data available
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose / concentration:
- No data available
- Control animals:
- not specified
- Positive control reference chemical:
- No data available
- Details on study design:
- No data available
- Details on dosing and sampling:
- No data available
- Statistics:
- No data available
- Preliminary studies:
- No data available
- Type:
- absorption
- Results:
- No data available
- Type:
- distribution
- Results:
- No data available
- Type:
- metabolism
- Results:
- Metabolism taks plase by O-conjugates and give , ethereal sulphate, ester glucuronide, ether glucuronide and ether-soluble acid
- Type:
- excretion
- Results:
- excreted in urine
- Details on absorption:
- No data available
- Details on distribution in tissues:
- No data available
- Details on excretion:
- 1% free non-acidic phenol, 13% ethereal sulphate, 1 % ester glucuronide, 50 % ether glucuronide and 69 % ether-soluble acid were recovered in urine
- Metabolites identified:
- yes
- Details on metabolites:
- The major portion of the dose (77-93 %) being excreted as O-conjugates. the values for ether glucuronide are somewhat lower than those for the ether-soluble acid. This difference probably arises from decomposition occurring during the preliminary hydrolysis which case the crystals obtained were shown by comparison is carried out in 5N-sulphuric acid.
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
On the basis of observed result it is concluded that 2,3-dimethylphenol show O-conjugates metabolism and excreted in the form of ethereal sulphate, ester glucuronide, ether glucuronide and ether-soluble acid in urine. Hence, expected to have Low bio-accumulation potential based on study results. - Executive summary:
In a in vivo metabolism study, rabbit were treated with 2,3-dimethylphenol orally by gavage at 1000 mg. It was observed that 2,3-dimethylphenol were excreted as O-conjugates by preliminary hydrolysis which case the crystals obtained were shown by comparison is carried out in 5N-sulphuric acid. 1% free non-acidic phenol, 13% ethereal sulphate, 1 % ester glucuronide, 50 % ether glucuronide and 69 % ether-soluble acid were recovered in urine.Therefore, On the basis of observed result it is concluded that 2,3-dimethylphenol show O-conjugates metabolism and excreted in the form of ethereal sulphate, ester glucuronide, ether glucuronide and ether-soluble acid in urine. Hence, expected to have Low bio-accumulation potential based on study results.
Reference
Excretion of metabolites of xylenols in the rabbit
|
|
Excretion |
|
2:3-Xylen-1-ol |
No. Of Experiments |
Range (%) |
Average (%) |
Free non-acidic phenol |
4 |
0-4-1-6 |
1 |
Ethereal sulphate |
3 |
11-14 |
13 |
Ester glucuronide |
6 |
0-3 |
1 |
Ether glucuronide |
6 |
37-69 |
50 |
Ether-soluble acid |
6 |
55-86 |
69 |
Description of key information
In a in vivo metabolism study, rabbit were treated with 2,3-dimethylphenol orally by gavage at 1000 mg. It was observed that 2,3-dimethylphenol were excreted as O-conjugates by preliminary hydrolysis which case the crystals obtained were shown by comparison is carried out in 5N-sulphuric acid. 1% free non-acidic phenol, 13% ethereal sulphate, 1 % ester glucuronide, 50 % ether glucuronide and 69 % ether-soluble acid were recovered in urine.Therefore, On the basis of observed result it is concluded that 2,3-dimethylphenol show O-conjugates metabolism and excreted in the form of ethereal sulphate, ester glucuronide, ether glucuronide and ether-soluble acid in urine. Hence, expected to have Low bio-accumulation potential based on study results.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
In a in vivo metabolism study, rabbit were treated with 2,3-dimethylphenol orally by gavage at 1000 mg. It was observed that 2,3-dimethylphenol were excreted as O-conjugates by preliminary hydrolysis which case the crystals obtained were shown by comparison is carried out in 5N-sulphuric acid. 1% free non-acidic phenol, 13% ethereal sulphate, 1 % ester glucuronide, 50 % ether glucuronide and 69 % ether-soluble acid were recovered in urine.Therefore, On the basis of observed result it is concluded that 2,3-dimethylphenol show O-conjugates metabolism and excreted in the form of ethereal sulphate, ester glucuronide, ether glucuronide and ether-soluble acid in urine. Hence, expected to have Low bio-accumulation potential based on study results.
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