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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1961
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (limited documentation).

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:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Study was performed before actual guideline was established. Limited documentation.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MRD-61-34 (ISOPAR E)
- Physical state: colorless liquid
- Substance type: colorless liquid
- Analytical purity: 100% commercial product
- Other: aromatic odor

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals 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:
> 10 mL/kg bw
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)
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 body weight 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:

No data is available for 2,2,3-trimethylbutane. However, data is available for hydrocarbons, C7-C9, isoalkanes and is being read across to using the category approach explained in the category justification document attached to Section 13 of the dossier.

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