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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22/11/1983 - 16/12/1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study according to methodology comparable to OECD guideline 401. Several minor deviations from guideline. Performed under QA.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EPA 43:163, 37336-37402 (1978)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981 guideline
Deviations:
yes
Remarks:
see overall remarks
Principles of method if other than guideline:
Not relevant
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Fyrquel LT
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan
- Weight at study initiation: males: 181-211 g; females: 151-174 g
- Fasting period before study: 16-18 hours



IN-LIFE DATES: From: not mentioned To: not mentioned

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bodyweight
Doses:
5000 mg/kg bodyweight
No. of animals per sex per dose:
10 males and 10 females
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: once to twice per day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy
Statistics:
No data

Results and discussion

Preliminary study:
Not relevant
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No male or female rats died during the observation period.
Clinical signs:
Males: Adverse clinical signs for all rats included mild to moderate depression, stained fur, diarrhea, reddish facial stains, and stained anogenital areas. The rats appeared normal by day 3.
Females: Adverse clinical signs for all rats included mild to moderate depression, piloerection, reddish stained muzzles, lacrimation, chromodacryorrhea, diarrhea, and yellowish-brown anogenital stains. The only other sign was alopecia (1 rat). The rats appeared normal by day 4 with the exception of alopecia (1 rat) that was observed through day 14.
Body weight:
No data
Gross pathology:
Males: Ten rats were necropsied following termination on day 14. Observations included pleural membranes adhered to wall of thoracic cavity, pericardium and diaphragm; clear and/or creamy fluid in the lungs, and mottled lungs (1 rat).
Females: Ten rats were necropsied following termination on day 14 and appeared normal.
Other findings:
A total of ten rats were dosed with corn oil and served as vehicle controls. The only adverse clinical sign for all rats was mild diarrhea. The rats appeared normal within 5 (females) or 24 (males) hours. Rats appeared normal during necropsy.

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity (LD50) of Fyrquel LT towards rats is > 5000 mg/kg bodyweight.
Executive summary:

The acute oral toxicity of Fyrquel LT towards male and female rats was determined according to methodology comparable to OECD Guideline 401. Ten male and ten female rats were exposed to 5000 mg/kg bodyweight of the test substance and observed for 14 days. The LD50 (for both male and female rats) was found to be > 5000 mg/kg bodyweight under the conditions of this stud

Based on the results and according to the criteria outlined in regulation 1272/2008/EC (CLP/EU-GHS) Fyrquel LT does not have to be classified and has no obligatory labelling requirement for oral toxicity.