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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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.
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
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
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality occurred in any test animal over the 14-day observation period.
Clinical signs:
other: Clinical observations noted one-hour post exposure in 8 of 10 animals included depression, salivation, wheezing, rough coat, and soft feces. Two female rats appeared normal throughout the study. All animals appeared normal from day 2 through termination
Gross pathology:
No abnormal gross pathology findings were noted in any of the animals upon necropsy.
Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: other: GHS, EU, 2007
Conclusions:
Based on the study design the test substance, Isooctane, needs not to be classified.
Executive summary:

This data is being read across from the source study that tested 2,2,4-trimethylpentane based on analogue read across.

Based on the study design the test substance, Isooctane, needs not to be classified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Limit test with 5000 mg/kg versus 2000 mg/kg as per guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Limit test with 5000 mg/kg versus 2000 mg/kg as per guideline
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,4-trimethylpentane
EC Number:
208-759-1
EC Name:
2,2,4-trimethylpentane
Cas Number:
540-84-1
Molecular formula:
C8H18
IUPAC Name:
2,2,4-trimethylpentane
Constituent 2
Reference substance name:
208-758-1
IUPAC Name:
208-758-1
Details on test material:
- Name of test material (as cited in study report): Isooctane
- Analytical purity: 100% pure commercial product

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily; weighing on initiation and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality occurred in any test animal over the 14-day observation period.
Clinical signs:
other: Clinical observations noted one-hour post exposure in 8 of 10 animals included depression, salivation, wheezing, rough coat, and soft feces. Two female rats appeared normal throughout the study. All animals appeared normal from day 2 through termination
Gross pathology:
No abnormal gross pathology findings were noted in any of the animals upon necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: other: GHS, EU, 2007
Conclusions:
Based on the study design the test substance, Isooctane, needs not to be classified.
Executive summary:

Based on the study design the test substance, Isooctane, needs not to be classified.