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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
5 270 mg/kg bw
95% CL:
4 030 - 6 950
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:
The main clinical signs were hypoactivity, ataxia, prostration, diarrhoea, hair loss and eye opacity
Body weight:
Weight gain unremarkable in survivors
Gross pathology:
No abnormalities detected
Other findings:
None

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.