Registration Dossier

Administrative data

Description of key information

Acute oral toxicity 
Acute dermal toxicity
Acute inhalation toxicity

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
1.81 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral, inhalation and dermal toxicity studies were performed in male and female rats with FR-370.

Acute Oral toxicity: No mortalities were observed in either sex following oral administration of 5000 mg/kg. All rats gained weight during the study. No gross internal lesions were noted in any animal at necropsy.

The only clinical signs noted were chromorhinorrhea, diarrhea, chromodacryorrhea and abdominogenital staining. These symptoms appeared during the first 3 -6 hours after dosing and vanished afterwards.

The oral LD50 of the test material is judged to be greater than 5000 mg/kg to both male and female rats. Under the conditions of the study test material was classified as practically non-toxic by oral administration.

Acute Dermal toxicity: No mortalities were observed in either sexes following dermal application of 2000 mg/kg of FR-370.

No signs of systemic toxicity were noted during clinical observations in both studies?? No abnormalities were noted during necropsy in both studies. The only clinical signs noted were chromodacryorrhea, chromorhinorrhea and diarrhea shortly after dosing. All rats recovered by study day 3 and remained healthy until termination.

The oral LD50 of the test material was determined to be greater than 2000 mg/kg to both male and female rats. Under the conditions of the study test material was classified as non-toxic by dermal application.

Acute Inhalation toxicity: No mortality was observed during 14 days after a single exposure for 4 hours to 1.8 mg/l FR-370  (maximum attainable concentration). There were no significant clinical signs noted during or after the exposure to the test material.

A few non-significant clinical signs were noted during the exposure, upon removal from the chamber and at
one hour post-exposure including abdominogenital staining, chromorhinorrhea, dust on fur, lacrimation and squinting eyes.

All animals recovered by study day 1 and remained healthy through study termination. All animals gained weight by termination on day 14. There were no gross internal lesions noted in any animal at necropsy.
The LC50 was determined to be 1.81 mg/l (maximum attainable concentration). Under the condition of this test the test item was

classified as non-toxic by inhalation.

FR-370 is not classified for acute oral toxicity or acute inhalation toxicity or acute dermal toxicity.

Justification for classification or non-classification

Based on the experimental results and according to the EEC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC, 27th April 1993), FR-370 does not have to be classified and has no obligatory labelling requirement for acute toxicity .