Fuel oil, residual

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Near-guideline, GLP-compliant study. Adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

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:

The test substance was administered by oral gavage to male and female rats and animals observed for 14 days. Body weights were recorded the prior to treatment and again at gross necropsy on day 14.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

64741-62-4

Cas Number:

64741-62-4

IUPAC Name:

64741-62-4

Test material form:

other: Viscous hydrocarbon liquid

Details on test material:

Catalytic cracked clarified oil (CCCO), API 81-15, CAS No. 64741-62-4.
Tar like semi solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Age at study initiation: approx. 9 wk
- Fasting period before study: overnight

IN-LIFE DATES: From: 3 March 1982 To: 17 March 1982

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Animals fasted prior to treatment

Doses:

3.20, 4.00, 5.00, 6.25 and 7.81 g/kg body weight

No. of animals per sex per dose:

5 per sex per dose level

Control animals:

no

Details on study design:

The test substance was administered by oral gavage to male and female rats and animals observed for 14 days. Body weights were recorded the prior to treatment and again at gross necropsy on day 14.

Statistics:

The LD50 was calculated according to the method of Finney (1971) Statistical Methods in Biological assay, 3rd edition, p50-90 (no further details)

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

5 270 mg/kg bw

95% CL:

> 4 030 - < 6 950

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

4 320 mg/kg bw

95% CL:

> 2 650 - < 5 470

Mortality:

Mortality by dose level:
3200 mg/kg - 20%
4000 mg/kg - 40%
5000 mg/kg - 40%
6250 mg/kg - 80%
7810 mg/kg - 100%

Clinical signs:

other: The main clinical signs were hypoactivity, ataxia, prostration, diarrhoea, hair loss and eye opacity

Gross pathology:

No abnormalities detected

Other findings:

Weight gain unremarkable in survivors

Any other information on results incl. tables

In addition to mortalities, the main clinical signs were hypoactivity, ataxia, prostration, diarrhoea, hair loss and eye opacity.  The LD₅₀ values for male and female animals were 5270 and 4320 mg/kg respectively.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 = 4320 (females) - 5270 (males)

Executive summary:

The test substance was administered to groups of fasted male and female SD rats (n = 5/sex) at dose levels of 3200 – 7810 mg/kg bw followed by a 14 day observation period.

Variable mortality was present at treatment levels of 4000 mg/kg bw and above, with complete mortality in the high dose group. The main clinical signs were hypoactivity, ataxia, prostration, diarrhoea, hair loss and eye opacity but no lesions were visible at scheduled necropsy in survivors. 

The acute oral LD₅₀ was 4320 mg/kg bw in females and 5270 mg/kg bw in males.