Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is an acceptable well-documented publication which meets basic scientific principles.
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:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is an acceptable well-documented publication which meets basic scientific principles.
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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Pre-GLP study
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Long-Evans
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 150-300 g

Route of administration:
oral: gavage
Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 25 ml/kg
Doses:
up to 25 ml/kg
No. of animals per sex per dose:
6 males
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

Statistics:
Litchfield and Wilcoxen.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 25 mL/kg bw
Remarks on result:
other: 16.75 g/kg
Mortality:
No mortality at doses up to 25 ml/kg (16.75 g/kg (density 0.67)).
Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 for rats is > 25 mL/Kg.
Executive summary:

This study examined the oral toxicity of commercial hexane. 6 male rats were given doses of up to 25 mL/Kg of test substance by oral gavage. The animals were then observed for 14 days for mortality.

No mortality was observed at any of the doses. The oral LD50 is therefore > 25 mL/Kg (16.75 g/Kg; density of 0.67).

Data source

Reference
Reference Type:
publication
Title:
The Toxicological Properties of Hydrocarbon Solvents
Author:
Hine, CH, and Zuidema, HH
Year:
1970
Bibliographic source:
Industrial Medicine, Vol. 39, No. 5, May 1970.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Pre-GLP study
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane
IUPAC Name:
C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane
Details on test material:
- Name of test material (as cited in study report): S-1
- Composition of test material, percentage of components: C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane

Test animals

Species:
rat
Strain:
Long-Evans
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 150-300 g

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 25 ml/kg
Doses:
up to 25 ml/kg
No. of animals per sex per dose:
6 males
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

Statistics:
Litchfield and Wilcoxen.

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 25 mL/kg bw
Remarks on result:
other: 16.75 g/kg
Mortality:
No mortality at doses up to 25 ml/kg (16.75 g/kg (density 0.67)).

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 for rats is > 25 mL/Kg.
Executive summary:

This study examined the oral toxicity of commercial hexane. 6 male rats were given doses of up to 25 mL/Kg of test substance by oral gavage. The animals were then observed for 14 days for mortality.

No mortality was observed at any of the doses. The oral LD50 is therefore > 25 mL/Kg (16.75 g/Kg; density of 0.67).