Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
July - September 1961
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Limited documentation.
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:
July - September 1961
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Limited documentation.
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
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 7 100 - 7 800 mg/kg bw
Remarks on result:
other: recalculated values based on the LD50 of 10 mL/kg bw; the range is due to the range of density (0.71-0.78 g/cm3)
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Mortality:
The test material produced no deaths at any dosage level tested.
Gross pathology:
There were no pathological findings in any animal at autopsy following sacrifice.
Other findings:
The animals at all dosage levels seemed normal in appearance and behaviour following intubation and daily during the 14 -day observation period.

The acute oral LD50 of MRD-61-33 for male albino rats is therefore greater than 10 mL/kg bw corresponding to 7100 - 7800 mg/kg bw.

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: other: CLP
Conclusions:
Under the conditions of this study the test substance, hydrocarbons, C7-C9, isoalkanes, does not need to be classified.
Executive summary:

This data is being read across from the source study that tested hydrocarbons, C7-C9, isoalkanes, based on analogue read across.

Under the conditions of this study the test substance, C7-C9, isoalkanes, does not need not to be classified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961
Report date:
1961

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Study was performed before actual guideline was established.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrocarbons, C7-C9, isoalkanes
EC Number:
921-728-3
Cas Number:
64741-66-8
Molecular formula:
None available - not a single isomer - see remarks
IUPAC Name:
Hydrocarbons, C7-C9, isoalkanes
Details on test material:
- Name of test material (as cited in study report): MRD-61-33 (ISOPAR C)
- Physical state: colorless liquid
- Substance type: colorless liquid
- Analytical purity: 100% pure commercial product
- Other: aromatic odor

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 101 - 132 g
- Fasting period before study: Food was withheld from the animals for a period of 3 to 4 hours prior to dosage.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.1, 1.0 or 10 % volume/volume solution in corn oil (Mazola)
Doses:
31.6; 100; 316; 1000; 3160; and 10,000 µL/kg body weight
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations (mortality and toxic effects): immediately after administration; at 1, 4 and 24 hours; and once daily thereafter for a total of 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, pathology (brain, liver, kidney), blood levels were collected by exsanguination
Statistics:
no data

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 7 100 - 7 800 mg/kg bw
Remarks on result:
other: recalculated values based on the LD50 of 10 mL/kg bw; the range is due to the range of density (0.71-0.78 g/cm3)
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Mortality:
The test material produced no deaths at any dosage level tested.
Gross pathology:
There were no pathological findings in any animal at autopsy following sacrifice.
Other findings:
The animals at all dosage levels seemed normal in appearance and behaviour following intubation and daily during the 14 -day observation period.

Any other information on results incl. tables

The acute oral LD50 of MRD-61-33 for male albino rats is therefore greater than 10 mL/kg bw corresponding to 7100 - 7800 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: other: CLP
Conclusions:
Under the conditions of this study the test substance, hydrocarbons, C7-C9, isoalkanes, does not need to be classified.
Executive summary:

Under the conditions of this study the test substance, C7-C9, isoalkanes, does not need not to be classified.