Registration Dossier
Registration Dossier
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EC number: 941-379-0 | CAS number: -
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Read across justification included in Section 13
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Read across justification included in Section 13
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- read-across source
- Objective of study:
- absorption
- Qualifier:
- no guideline available
- GLP compliance:
- yes
- Radiolabelling:
- yes
- Species:
- mouse
- Strain:
- C3H
- Sex:
- male
- Route of administration:
- dermal
- Vehicle:
- other: mineral oil
- Duration and frequency of treatment / exposure:
- 96 hour(s)
- Remarks:
- Doses / Concentrations:
Males: 15 µl undiluted and 60 µl diluted to 25% with mineral oil - No. of animals per sex per dose / concentration:
- Males: 5
- Control animals:
- yes, concurrent vehicle
- Details on absorption:
- radio labelled tetradecane and naphthalene were absorbed at 5% and 12% respecively from neat kerosine. For a 25% dilution in mineral oil the compartaive absorption was 7 and 14%
- Details on distribution in tissues:
- radio labelled naphthalene was found inn urine and to a much lesser extent in faeces and tissues.
radio labelled tetradecane was found in expired air and to a lesser extent in urine, faeces and tissues. - Toxicokinetic parameters:
- half-life 1st:
- Toxicokinetic parameters:
- half-life 2nd:
- Toxicokinetic parameters:
- half-life 3rd:
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
radio labelled tetradecane and naphthalene (as surrogates for aliphaltic and aromatic constituents) were absorbed through the skin following dermal application of kerosine. Excretion was via urine and expired air and there was little evidnec of tissue accumulation. - Executive summary:
Topical application of radiolabelled kerosine (C14 tetradecane and naphthalene) in mice resulted in low levels of dermal uptake. Absorbed material was excreted in urine and expired air and there was little evidence of tissue accumulation.
In
the study with dermally applied undiluted test material approximately 5%
of the labelled tetradecane and 15% of the labelled naphthalene was absorbed
over 96 hours.
In the study with the 25% concentration of test material, approximately 7%
of the labelled tetradecane and 16% of the labelled naphthalene was absorbed
over 96 hours.
In the passive inhalation study approximately 2.8% (undiluted test material)
and 1.8% (25% concentration) of the labelled naphthalene was available. In
contrast, approximately 0.2% of labelled tetradecane in undiluted
and diluted test material was absorbed.
These studies demonstrate that dilution of the test material in mineral oil
did not influence absorption of the radiolabelled
"spikes" present.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- yes
Test material
- Reference substance name:
- most likely 800-20-6
- IUPAC Name:
- most likely 800-20-6
- Test material form:
- other: low viscosity liquid hydrocarbon
- Details on test material:
- Blend of straight run hydrotreated kerosine (30%) and hydrocracked kerosine (70%), spiked with C14 labelled tetradecane and naphthalene
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- mouse
- Strain:
- C3H
- Sex:
- male
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- other: mineral oil
- Duration and frequency of treatment / exposure:
- 96 hour(s)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Males: 15 µl undiluted and 60 µl diluted to 25% with mineral oil
- No. of animals per sex per dose / concentration:
- Males: 5
- Control animals:
- yes, concurrent vehicle
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- radio labelled tetradecane and naphthalene were absorbed at 5% and 12% respecively from neat kerosine. For a 25% dilution in mineral oil the compartaive absorption was 7 and 14%
- Details on distribution in tissues:
- radio labelled naphthalene was found inn urine and to a much lesser extent in faeces and tissues.
radio labelled tetradecane was found in expired air and to a lesser extent in urine, faeces and tissues.
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- half-life 1st:
- Toxicokinetic parameters:
- half-life 2nd:
- Toxicokinetic parameters:
- half-life 3rd:
Any other information on results incl. tables
In
the study with dermally applied undiluted test material approximately 5%
of the labelled tetradecane and 15% of the labelled naphthalene was absorbed
over 96 hours.
In the study with the 25% concentration of test material, approximately 7%
of the labelled tetradecane and 16% of the labelled naphthalene was absorbed
over 96 hours.
In the passive inhalation study approximately 2.8% (undiluted test material)
and 1.8% (25% concentration) of the labelled naphthalene was available. In
contrast, approximately 0.2% of labelled tetradecane in undiluted
and diluted test material was absorbed.
These studies demonstrate that dilution of the test material in mineral oil
did not influence absorption of the radiolabelled
"spikes" present.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
radio labelled tetradecane and naphthalene (as surrogates for aliphaltic and aromatic constituents) were absorbed through the skin following dermal application of kerosine. Excretion was via urine and expired air and there was little evidnec of tissue accumulation. - Executive summary:
Topical application of radiolabelled kerosine (C14 tetradecane and naphthalene) in mice resulted in low levels of dermal uptake. Absorbed material was excreted in urine and expired air and there was little evidence of tissue accumulation.
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