Registration Dossier

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:
5.192 mg/m³

Acute toxicity: via dermal route

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

Additional information

In total three studies are available for the acute oral, dermal and inhalation toxicity.

The acute oral toxicity of ITTFEP (purity 82.3%) 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 toxicity testing in 3 male and 3 female rats showed that the LD50 of the test item was > 2000mg/kg body weight. No mortalities were observed. The body weight evolution was not influenced during the 14-day observation period. There were no in-life observations indicating treatment-related systemic effects on any males. Slight reduced activity was observed in all females on the treatment day which lasted in once female (no. 101) through day 1, and in one female (no. 102) through day 2, slightly hunched posture in two females (no 101 and 103) on the treatment day through day 1, and in one female (no. 102) on the treatment day through day 4, slight piloerection in all females on the treatment day, which lasted in one female (no. 102) through day 2. In addition, skin cold to touch, recumbency, and slight dyspnea were seen in one female (no. 102) on days 1 and 2. All females appeared normal on day 5 after treatment. The obtained results are considered as relevant for the risk assessment.

The acute dermal toxicity of ITTFEP (purity 82.3%) to rat was determined in a GLP compliant test according to OECD 402 (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 was > 2000mg/kg body weight. No mortality was observed. There were no remarkable clinical observations for any animal. There were only slight effects on body weight development in males. A slight loss of body weight was recorded in one female during the first 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 ITTFEP (purity 82.3%) 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 the test item was > 5.192 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 ITTFEP 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/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 ITTFEP 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 test item /kg bw or 5 mg/L. Therefore, there is no need for classification and labelling.