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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity, rat (OECD Guideline 401): LD50 > 5000 mg/kg bw
Acute dermal toxicity study, rat (OECD Guideline 402): LD50 >2000 mg/kg bw
Acute inhalation toxicity study, rat, nose only (OECD guideline 403): LC50 > 4,14 mg/L

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:
4 140 mg/m³ air

Acute toxicity: via dermal route

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

Additional information

For the acute oral toxicity 5 similar rat studies are available, all indicating that the LD50 is > 5000 mg/kg body weight. The key study is an acute oral toxicity study of RDP, investigated according to international guidelines (OECD guideline 401, EU Method B.1) under GLP. Five male and five female rats were exposed to a concentration of 5000 mg/kg bodyweight of the test substance (chemical identity and purity not reported). After 14 days no deaths or signs of toxicity were recorded, neither did macroscopic necropsy reveal any results caused by the treatment. The oral LD50 for both male and female rats was determined to be > 5000 mg/kg bodyweight.

In a similar study the acute oral toxicity of the test substance (purity 61.9%) was investigated according to OECD guideline 401. 10 female and 10 male rats were exposed to 5000 mg/kg bodyweight of the test substance by gavage and observed for 14 days. Mortality, clinical signs, Monocyte Non-Specific Esterase Determination, Gross Pathology, Gross necropsy were recorded. The LD50 for both male and female rats was determined to be > 5000 mg/kg bodyweight. MNSE activity was significantly decreased 14 days after dosing in both male and female rats.

In another acute oral study 5 male 5 female rats were exposed to 5000 mg/kg body weight. No treatment-related effects on cholinesterase levels were observed in male rats, whereas in female rats cholinesterase levels were significantly reduced up till 72 hrs after dosing. After 7 days, cholinesterase levels had returned to normal.

 

The acute dermal toxicity of RDP towards Wistar rats was investigated according to OECD guideline 402 under GLP. Rats were exposed to 2000 mg/kg bodyweight of the test substance for 24 hours and observed for 14 days. The LD50 was determined to be > 2000 mg/kg bodyweight for both males and females.

In another similar dermal study, which is included as a supporting study, MSNE activity was significantly decreased in both males and females fourteen days after dermal exposure of 2000 mg/kg body weight..

 

The acute inhalation toxicity of Fyrolflex RDP towards rats was investigated according to OECD guideline 403 under GLP. Ten male and ten female rats were exposed to 4.14 mg/L (measured concentration) of the test substance for 4 hours and observed for 14 days. The LC50 was found to be > 4.14 mg/l. MSNE activity was reduced significantly one day after exposure in both males and females, but had returned to normal after 14 days.

A supporting study is available in which the acute inhalation toxicity of CR-733 -S was investigated according to OECD guideline 403 under GLP. Five male and five female rats were exposed to 4.86 mg/l of the test substance for 4 hours and observed for 14 days. The LC50 was found to be > 4.86 mg/l for both male and female rats.

In addition to the studies above, an acute toxicity study via intraperitoneal injection is available which is included as a supporting study. An LD50 >6500 mg/kg bw was observed, which supports the findings in the oral, dermal and inhalation studies that RDP is not acutely toxic.

Justification for classification or non-classification

Based on the available toxicity information RDP has been shown to be not acute toxic when applied via the oral, dermal and inhalation route. Therefore, RDP does not need to be classified for acute toxicity, according to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC), and outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).