Registration Dossier

Administrative data

Description of key information

1. Oral LD50 > 2000 mg/kg bw, rat, OECD420;
2. Dermal LD50 > 2000 mg/kg bw, rat, OECD 402.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
The key study is a GLP compliant and has Klimish score 1.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
The study is a GLP compliant and has Klimish score 1.

Additional information

Acute toxicity: oral

The key study was performed to assess the acute oral toxicity of the test item (reaction product of amines, C12-14,-tert-alkyl, alcohol, C14-18, C18 unsat, and phosphorus pentoxide) in the Wistar strain rat according to OECD 420 (Sanders, 2012; Report No. 41104597).

Following a sighting test in one animal at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as a solution in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths and signs of systemic toxicity. All animals showed expected gains in bodyweight. Raised limiting ridge in the stomach was noted at necropsy of one animal. No abnormalities were noted at necropsy of the remaining animals. In conclusion, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified).

Acute toxicity: dermal:

The study was performed to assess the acute dermal toxicity of the test item (reaction product of amines, C12-14,-tert-alkyl, alcohol, C14-18, C18 unsat, and phosphorus pentoxide) in the Wistar strain rat according to the OECD 402 (Sanders, 2012b, Report No. 41104591).

A group of ten animals (five males and five females) was given a single, 24 hour, semi‑occluded dermal application of the undiluted test item to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths or signs of systemic toxicity. Very slight erythema was noted at the test sites of nine animals. Crust formation and small superficial scattered scabs were also noted at the test site of one male. There were no signs of dermal irritation noted at the test site of one male. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. In conclusion, the acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – inhalation endpoint
Inhalation is not a relevant route of exposure.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

The "reaction product of amines, C12-14,-tert-alkyl, alcohol, C14-18, C18 unsat, and phosphorus pentoxide" had LD50 greater than 2000 mg/kg bw for acute oral and dermal toxicity. Inhalation is not a relevant route of exposure. Therefore, it does not meet the criteria for classification and labelling for oral, dermal or inhalatory toxicity in accordance with European regulation (EC) No. 1272/2008.