Registration Dossier
Registration Dossier
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EC number: 209-057-8 | CAS number: 554-00-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: significant data on methemoglobin formation although reported in brief
Data source
Reference
- Reference Type:
- publication
- Title:
- Methemoglobin formation by aromatic amines.
- Author:
- McLean S, Starmer GA, Thomas J
- Year:
- 1 969
- Bibliographic source:
- J Pharm Pharmac 21, 441-450
Materials and methods
- Objective of study:
- other: determination of methemoglobinemia
- Principles of method if other than guideline:
- 5 cats received oral dose of 0.25 mmol/kg bw once and the amount of methemoglobin formation was measured over a period of 5 hours
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,4-dichloroaniline
- EC Number:
- 209-057-8
- EC Name:
- 2,4-dichloroaniline
- Cas Number:
- 554-00-7
- Molecular formula:
- C6H5Cl2N
- IUPAC Name:
- 2,4-dichloroaniline
- Test material form:
- not specified
- Details on test material:
- no data
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- cat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- as discribed in McLean J Pharm Pharmac 19, 146-154 (1967)
adult cats, older than 24 weeks, were used
food was witheld from animals for 16 hours before a start of an experiment
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% methylcellulose mucilage
- Details on exposure:
- 5 cats received oral dose of 25 mmol/kg bw dissolved in 1% methylcellulose mucilage once and the amount of methemoglobin formation was measured over a period of 5 hours
- Duration and frequency of treatment / exposure:
- once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.25 mmol/kg bw
- No. of animals per sex per dose / concentration:
- 5
- Control animals:
- not specified
- Positive control reference chemical:
- no data
- Details on study design:
- adult cats, older than 24 weeks, were used
food was witheld from animals for 16 hours before a start of an experiment
5 cats received oral dose of 0.25 mmol/kg bw in 1% methylcellulose mucilage once and the amount of methemoglobin formation was measured by taking blood from femoral vein just before and at 1 h -intervals after treatment up to 5 hours. - Details on dosing and sampling:
- 5 cats received oral dose of 0.25 mmol/kg bw in 1% methylcellulose mucilage once and the amount of methemoglobin formation was measured over a period of 5 hours. Blood was taken from femoral vein just before and at intervals after treatment
- Statistics:
- mean values from 5 cats
Results and discussion
Main ADME results
- Type:
- other: determination of methemoglobin
- Results:
- Mean methemoglobin percentage formed after 5 hours was 31.7 % with a mean max of42.0 %
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- no details
- Details on distribution in tissues:
- no details
- Details on excretion:
- no details
Metabolite characterisation studies
- Details on metabolites:
- no data
Any other information on results incl. tables
0.25 mmol/kg bw to 5 cats; mean value of methemoglobin formation
after 1h: 39.3 %;
after 2 h: 37.3 %;
after 3 h: 31.5%;
after 4 h: 27.6 %;
after 5 h: 22.6 %
Applicant's summary and conclusion
- Executive summary:
5 cats received oral dose of 0.25 mmol/kg bw in 1% methylcellulose mucilage once and the amount of methemoglobin formation was measured over a period of 5 hours. Blood was taken from femoral vein just before and at intervals after treatment. Mean methemoglobin percentage formed after 5 hours was 31.7 % with a mean max of 42.0 %
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