Bis(2,4,4-trimethylpentyl)phosphinic acid

Endpoint summary

Description of key information

Oral: LD50 (rat, male and female) = 5444 mg/kg bw
Inhalation: no data available, waiving
Dermal: LD50 (rabbit, male/female)> 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 444 mg/kg bw

Quality of whole database:

Two tests were available with good reliability (Klimisch score = 2). The tests were performed in compliance with the GLP and with international guidance requirements with acceptable restrictions.

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:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Two tests were available with good reliability (Klimisch score = 2). The tests were performed in compliance with the GLP and with international guidance requirements with acceptable restrictions.

Additional information

Acute Oral Toxicity

Two studies were available for the acute oral toxicity and both studies gave consistent results.

In the acute oral toxicity key study, performed similarly to the OECD guideline No. 401, and in compliance with the GLP, groups of (SD) male and female rats were given a single oral dose (by gavage) of undiluted test material. Rats were administered by gavage test material at doses of 2500; 3500; 4000; 5000 and 6500 mg/kg bw. Death is observed at all dose levels except at 3500 mg/kg bw. Signs of systemic toxicity were observed 30 min after dosing at all dose levels. Reactions ranged from lethargy, bodies cool to touch, red material round mouth and nose, loose feces and fecal stains to ataxia and inactivity. The severity and incidence of reactions increased with dose level. Furthermore, the mean bodyweight appeared to be decreased for the found dead animals. Positive gross pathologic findings were observed at all dose levels: gastrointestinal hemorrhage or appeared reddened, thickened area of stomach, intestines mucoid, intestine empty (at 6500 mg/kg bw dose level only).The combined oral LD50 in rats was therefore determined to be of 5444 mg/kg bw.

In the supporting study the combined oral LD50 in rats was determined higher than 3500 mg/kg bw.

 

Acute Dermal Toxicity

Two studies were available for the acute dermal toxicity and both studies gave consistent results.

In the acute dermal toxicity key study, performed similarly to the OECD test guideline No. 402 and in compliance with GLP, young adult albino New Zealand rabbits were dermally exposed to undiluted test material at the dose level of 2000 mg/kg bw for 24 hours under occlusive dressing. Prior to treatment, the skin of all animals was abraded (worst case approach). No animal died during the study and no animals exhibited signs of systemic toxicity. The combined dermal LD50 in rats was determined to be higher than 2000 mg/kg bw. Signs of local skin irritation were observed in most animals.

Justification for classification or non-classification

Based on the available data, the substance is not classified for oral and dermal acute toxicity according to the criteria of the CLP Regulation (EC) No 1272/2008 as the LD50 are higher than 2000 mg/kg bw and therefore higher than the threshold for classification.