Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via inhalation route

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

Acute toxicity: via dermal route

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

Additional information

The acute oral toxicity of CTFEP (purity 99%) to rat was determined in a GLP compliant test according to OECD 423 (Sommer 1999). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. The acute toxicity testing in 3 male and 3 female rats showed that the LD50 of the test item was > 2000mg/kg body weight. One day after treatment one male was found dead. No further mortalities were observed. The body weight evolution was not influenced during the 14-day observation period, except for one female which showed a weight loss until day 7 but recovered until day 14. All surviving animals showed piloerection and hunched posture within few days after administration but all of them recovered until day 14. All treated animals were free from poisoning symptoms after 11 days at the latest. The obtained results are considered as relevant for the risk assessment.

 

The acute dermal toxicity of CTFEP (purity 91.4%) to rat was determined in a GLP compliant test according to OECD 423 (Sommer 2000). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. The acute dermal toxicity testing in 5 male and 5 female rats showed that the LD50 of the test item (containing 91.4 % CTFEP) was > 2000mg/kg body weight. No mortality was observed. There were no remarkable clinical observations for any animal. There were no effects on body weight development in males. A slight loss of body weight was recorded in one female during the first week after treatment and in one female during the second week after treatment. Necropsy examinations revealed no observable abnormalities. There were no remarkable findings for local tolerance for any animal. The obtained results are considered as relevant for the risk assessment.

The acute 4-h nose-only inhalation toxicity of CTFEP (purity 91.4%) to rat was determined in a GLP compliant test according to OECD 403, EU method B.2 and EPA OPPTS870.1300 (Decker et al. 2001). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1.The acute inhalation toxicity testing in 5 male and 5 female rats showed that the LD50 of test item (containing 91.4 % CTFEP) was > 5.724 mg/L (limit test, analytically measured). Several slight to moderate clinical signs were observed. The body weight evolution was influenced during the first three days but recovered until day 14. All treated animals were free from poisoning symptoms after 5 days at the latest. The obtained results are considered as relevant for the risk assessment.

In summary, oral, dermal and inhalation acute toxicity were tested in various studies with CTFEP and its technical product, demonstrating that LD50 values were close to (due to the lower content of active ingredient) or above the limit dose of 2000 mg active ingredient/kg bw or 5 mg/L. Therefore, there is no need for classification and labelling.

Justification for classification or non-classification

Oral, dermal and inhalation acute toxicity were tested in various studies with CTFEP and its technical product, demonstrating that LD50 values were close to (due to the lower content of active ingredient) or above the limit dose of 2000 mg active ingredient/kg bw or 5 mg/L. Therefore, there is no need for classification and labelling.