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Diss Factsheets

Toxicological information

Basic toxicokinetics

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Administrative data

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:
other: Study meets generally accepted scientific principles, acceptable for assessment.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Preliminary studies:
Not performed
Details on absorption:
Not addressed.
Details on distribution in tissues:
Normal-Heptane demonstrated moderate concentrations in kidneys. In perirenal fat, concentration are highest, however decreasing with lasting exposure. This is in contrast to other n-alkanes, which showed increasing concentrations.
Key result
Test no.:
#1
Transfer type:
blood/brain barrier
Observation:
distinct transfer
Details on excretion:
Not addressed.
Metabolites identified:
not measured

Blood and tissue values in µmol/kg (with SD):

day

1

2

3

blood

2.4 ± 0.8

2.9 ± 0.9

2.1 ± 0.2

Brain

5.2 ± 0.8

6.9 ± 0.6

6.2 ± 1.0

liver

1.6 ± 0.6

2.3 ± 0.1

1.5 ± 0.1

kidney

15.7 ± 4.2

15.2 ± 2.6

17.1 ± 3.0

fat

140 ± 14

127 ± 28

121 ± 10

Conclusion:

n-Heptane was found in moderate concentrations in the kidneys and only in marginal concentrations in blood, brain and liver. In perirenal fat, concentrations were the highest, however, decreasing with lasting exposure.

Conclusions:
Interpretation of results (migrated information): other: see conclusions below
Normal-Heptane was found in moderate concentrations in the kidneys and only in marginal concentrations in blood, brain and liver. In perirenal fat, concentrations were the highest, however, decreasing with lasting exposure.
Executive summary:

This data is being read across from the source study that tested heptane based on analogue read across.

Normal-Heptane was found in moderate concentrations in the kidneys and only in marginal concentrations in blood, brain and liver. In perirenal fat, concentrations were the highest, however, decreasing with lasting exposure.

Data source

Reference
Reference Type:
publication
Title:
Inhalation kinetics of C6 to C10 aliphatic, aromatic and naphthenic hydrocarbons in rat after repeated exposures
Author:
Zahlsen, K. et al.
Year:
1992
Bibliographic source:
Pharmacology & Toxicology 71: 144-149

Materials and methods

Objective of study:
distribution
toxicokinetics
Principles of method if other than guideline:
3 day toxicokinetic study in rats.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Heptane
EC Number:
205-563-8
EC Name:
Heptane
Cas Number:
142-82-5
Molecular formula:
C7H21
IUPAC Name:
heptane
Details on test material:
- Name of test material (as cited in study report): n-Heptane
- Analytical purity: >99%
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Møllegaard A/S, L1, Skensved, Denmark
- Age at study initiation: 40-50 days
- Weight at study initiation: 150 - 200 g
- Individual metabolism cages: no
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4-6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±1 during exposure
- Humidity (%): 70 ± 20 during exposure
- Photoperiod (hrs dark / hrs light): 10/14

Administration / exposure

Route of administration:
inhalation: vapour
Vehicle:
unchanged (no vehicle)
Duration and frequency of treatment / exposure:
1, 2, and 3 days, 12 hours/day
Doses / concentrations
Remarks:
Doses / Concentrations:
0.52 mg/L (corresponding to 100 ppm)
No. of animals per sex per dose / concentration:
4 per exposure duration
Control animals:
no
Positive control reference chemical:
not applicable
Details on study design:
The aimed concentration was 1000 ppm. All exposures were performed at daytime for 12 hr (8 a.m. - 8 p.m.). Measurements were done on days 1, 2, and 3 after 12 hr exposure. Animals were one by one removed, killed, and blood and organs obtained within 3 min after removal from exposure chamber.
Details on dosing and sampling:
PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: blood, brain, liver, kidneys, perirenal fat
- Time and frequency of sampling: day 1, 2, and 3 within 3 min of removal from inhalation chamber

Results and discussion

Preliminary studies:
Not performed

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Not addressed.
Details on distribution in tissues:
Normal-Heptane demonstrated moderate concentrations in kidneys. In perirenal fat, concentration are highest, however decreasing with lasting exposure. This is in contrast to other n-alkanes, which showed increasing concentrations.
Transfer into organs
Key result
Test no.:
#1
Transfer type:
blood/brain barrier
Observation:
distinct transfer
Details on excretion:
Not addressed.

Metabolite characterisation studies

Metabolites identified:
not measured

Any other information on results incl. tables

Blood and tissue values in µmol/kg (with SD):

day

1

2

3

blood

2.4 ± 0.8

2.9 ± 0.9

2.1 ± 0.2

Brain

5.2 ± 0.8

6.9 ± 0.6

6.2 ± 1.0

liver

1.6 ± 0.6

2.3 ± 0.1

1.5 ± 0.1

kidney

15.7 ± 4.2

15.2 ± 2.6

17.1 ± 3.0

fat

140 ± 14

127 ± 28

121 ± 10

Conclusion:

n-Heptane was found in moderate concentrations in the kidneys and only in marginal concentrations in blood, brain and liver. In perirenal fat, concentrations were the highest, however, decreasing with lasting exposure.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: see conclusions below
Normal-Heptane was found in moderate concentrations in the kidneys and only in marginal concentrations in blood, brain and liver. In perirenal fat, concentrations were the highest, however, decreasing with lasting exposure.
Executive summary:

Normal-Heptane was found in moderate concentrations in the kidneys and only in marginal concentrations in blood, brain and liver. In perirenal fat, concentrations were the highest, however, decreasing with lasting exposure.