Naphtha (petroleum), light straight-run, co-processed with hydrocarbons derived from thermally cracked waste plastics

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report similar or equivalent to OECD 403. GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Gasoline

EC Number:

289-220-8

EC Name:

Gasoline

Cas Number:

86290-81-5

Constituent 2

Reference substance name:

API PS-6

IUPAC Name:

API PS-6

Test material form:

other: low viscosity liquid hydrocarbon

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

7500, 11250, 13125, 15000 and 18750 mg/kg of test substance.

No. of animals per sex per dose:

Four groups, each consisting of 5 male and 5 female Sprague-Dawley rats, and a fifth group containing 7 male and 6 female rats.

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

14 063 mg/kg bw

Mortality:

Mortality rates, in ascending dose order, were 0%, 30%, 60%,40% and 90%.

Clinical signs:

other: Clinical signs included diarrhea and blood around the nose and mouth.

Gross pathology:

At necropsy, lungs showed effects ranging from mild irritation and congestion to fluid-filled abscesses. Intestines, and often the stomach, were found to be haemorrhaging. In some animals the heart was enlarged or irregular.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the parameters of this study, the acute oral LD50 of the test material is 14063 mg/kg. These findings do not warrant classification of the test article as an acute oral toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).

Executive summary:

Four groups, each consisting of 5 male and 5 female Sprague-Dawley rats, and a fifth group containing 7 male and 6 female rats were dosed with 7500, 11250, 13125, 15000 and 18750 mg/kg of test substance by oral gavage. The test animals were observed hourly for the first six hours after dosing and twice daily for fourteen days. Mortality rats of the five dose groups (7500, 11250, 13125, 15000 and 18750 mg/kg) were 0%, 31%, 60%, 40% and 90%, respectively. Clinical signs included diarrhea and blood around the nose and mouth. At necropsy, lungs showed effects ranging from mild irritation and congestion to fluid-filled abscesses. Intestines, and often the stomach, were found to be hemorrhaging. In some animals the heart was enlarged or irregular.

Based on the parameters of this study, the acute oral LD50 of the test material is 14063 mg/kg. These findings do not warrant classification of the test article as an acute oral toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).