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EC number: 203-905-0 | CAS number: 111-76-2
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A published study that is reported in sufficient detail to judge it as sufficiently reliable to add to the overall understanding of the toxicokinetic assessment of this substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Inhalation toxicokinetics of butoxyethanol and its metabolite butoxyacetic acid in the male Sprague-Dawley rat.
- Author:
- Johanson G
- Year:
- 1 994
- Bibliographic source:
- Arch Toxicol, 68, -588-94
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Disposition of butoxyethanol and its metabolite butoxyacetic acid followed in rats following inhalation exposure over a period of days. Elimination in urine followed as well as disposition of the two substances in key tissues at interim sacrifice time points.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-butoxyethanol
- EC Number:
- 203-905-0
- EC Name:
- 2-butoxyethanol
- Cas Number:
- 111-76-2
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 2-butoxyethanol
- Details on test material:
- - Analytical purity: 99%
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- inhalation: vapour
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- no data
- Duration and frequency of treatment / exposure:
- up to 12 days.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 20 ppm
- Dose / conc.:
- 100 ppm
- No. of animals per sex per dose / concentration:
- 8
- Control animals:
- no
- Positive control reference chemical:
- none
- Details on study design:
- no further data
- Details on dosing and sampling:
- no further data
- Statistics:
- no data
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- In all the tissues examined, the 2-butoxyethanol concentration rapidly increased during the first three days and continue to increase more slowly during the remaining days of exposure.
- Type:
- distribution
- Results:
- Following a 100 ppm exposure the tissues concentrations were approximately 5 times higher higher in blood, 3.5 and 3.6 in muscle and testis respectively and 7.5 in the liver.
- Type:
- excretion
- Results:
- The blood clearance rate 2.6 +/- 1.3 l/h/kg bw. The urinary excretion of BAA averaged 0.2 mmol/day in the 20 ppm group and 1.03 mmol/day in the 100 ppm group. (64 % of the calculated respiratory uptake. The renal clearance was 0.53 l/h/kg.
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- The table below shows the tissue concentrations reached in the 20 ppm exposure group.
- Details on excretion:
- The blood clearance of 2-butoxyethanol was estimated to 2.6 +/- 1.3 l/h/kg bw whichever the dose administered. The kinetic profile of butoxyacetic acid was approximately the same as 2-butoxyethanol. The 100ppm/20ppm concentration ratios were: 4.4 for blood, 4.7 for muscle, 2.3 for testis and 5.3 for liver. The urinary excretion of butoxyacetic acid averaged 0.2 mmol/day in the 20 ppm group and 1.03 mmol/day in the 100 ppm group. This corresponds to 64 % of the calculated respiratory uptake. The renal clearance was 0.53 l/h/kg.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- 2-butoxyacetic acid
Any other information on results incl. tables
Average tissues concentrations of 2-BUTOXYETHANOL and butoxyacetic acid following 20 ppm exposure in mmol/l
Tissue concentration |
Blood |
Liver |
Muscle |
Testis |
2-butoxyethanol |
10 – 20 |
10 |
10 |
5 |
2-butoxyacetic acid |
30 – 40 |
15 – 20 |
10 |
10 |
Following a 100 ppm exposure the tissues concentrations were approximately 5 times higher higher in blood, 3.5 and 3.6 in muscle and testis respectively and 7.5 in the liver.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
2-butoxethanol is readily absorbed following inhalation exposure and rapidly perfuses tissues. However, it is also readily excreted in urine, substantially in the form of the metabolite 2-butoxyacetic acid. - Executive summary:
A toxicokinetic study in male rats showed that 2-butoxethanol is readily absorbed following inhalation exposure and rapidly perfuses tissues to concentrations of 25-100% of those found in the bloodstream. Absorbed levels are proportionate to exposure concentrations.The substance is readily eliminated in urine, substantially in the form of the metabolite 2-butoxyacetic acid.
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