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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
Study period:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report in agreement with OECD guideline 401. GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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)
Remarks:
none
Details on oral exposure:
The animals were dosed on 04Nov85 at a level of 5000 mg/kg. Each rat was dosed by drawing the specified volume into a 3cc syringe and orally intubating the restrained animal with a stainless steel gavage needle and introducing the test article into the stomach.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
Within 24 hours before dosing, each animal was weighed and observed for general health. The rats were randomly assigned to the test using a computer randomization program. All rats were fasted for approximately 16 hours before dosing.

The animals were dosed on 04Nov85at a level of 5000 mg/kg. Each rat was dosed by drawing the specified volume into a 3cc syringe and orally intubating the restrained animal with a stainless steel gavage needle and introducing the test article into the stomach.

Each animal was observed for the following: no observable abnormalities, oral discharge, nasal discharge, respiration, tremors, incoordination, recumbancy, and stools. The categories were on a 1 to 3 scoring scheme (slight, moderate, severe).
All animals were observed hourly for the first four hours the day of dosing and twice a day during the 14 -day observation period.

All animals at the conclusion of the study were subjected to a gross necropsy.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality among the test subjects was seen during the course of the study.
Clinical signs:
Loose stools and incoordination were the only clinical effects seen and there was observed only on the day after the dosing.
Body weight:
Body weight gain did not appear to be affected.
Gross pathology:
No lesions were seen in any animal.

Any other information on results incl. tables

No mortality among the test subjects was seen during the course of the study.

Loose stools and incoordination were the only clinical effect seen and they were observed only on the day after the dosing.

Body weight gain did not appear to be effected.

No lesions were seen in any animal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for F-64-01 in rats is >5000 mg/kg. Based on the parameters of this study, F-64-01 is not classified as an acute oral toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

The acute toxicity of F-64-01 was evaluated in rats via oral gavage at a dose of 5000 mg/kg fasted body weight. Observations were made hourly for the first 4 hours immediately after dosing and twice daily (a.m. and p.m.) for the next 14 days.  No animals died during the observational period. The LD50 for F-64-01 in rats is >5000 mg/kg. Based on the parameters of this study, F-64-01 is not classified as an acute oral toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.