Isoheptane

Acute Toxicity: oral

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 (Isooctane) 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 guideline

Test guideline 1

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

Test guideline 2

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

Test material information

Constituent 1

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.