Reaction Products of Diphosphorus Pentaoxide with n-Alcohols, C8-10 (even), salted with Amines, C12-14, Tert-alkyl

Endpoint summary

Description of key information

- Acute oral toxicity: EPA guideline, LD50 of 5000 mg/kg bw; mortalities and clinical signs at 5000 mg/kg bw; No effects: 2000 mg/kg bw.
- Acute dermal toxicity: EPA guideline, LD50 of greater than 2000 mg/kg bw; no mortalities; findings: clinical signs, dermal irritation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The study is GLP compliant and has Klimisch score of 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:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The study is GLP compliant and has Klimisch score of 1.

Additional information

Acute oral toxicity data

In a Limit Test according to the EPA Federal Register, Vol. 50, No. 188, Friday, September 27, 1985, the test item was orally administered to one group of ten fasted, 6-10 weeks old Sprague-Dawley rats (five males and five females), at a dose level of 5000 mg/kg as received with a post-observation period of 14 days (Mallory, 1993). Due to the mortality observed, an additional group of ten animals (five males and five females) was administered the test article at 2000 mg/kg in corn oil.

Clinical signs observed at 5000 mg/kg included decreased activity, chromodacryorrhea, abnormal gait, abnormal stance, decreased muscle tone, tremors and poor grooming. Clinical signs observed at 2000 mg/kg included chromodacryorrhea, salivation, diarrhea, tremors and elevated gait. There was an apparent increase in body weight for all surviving animals during the study. Five of ten animals died at 5000 mg/kg and none of the animals died at 2000 mg/kg. Necropsy of the animals that died on study revealed distended stomach and fluid-filled intestines. Terminal necropsy revealed mottled kidneys in one animal at 5000 mg/kg and three animals at 2000 mg/kg.

Based on the results from the Acute Exposure Oral Toxicity in rats, the estimated acute oral LD50 (combined sexes) for the test item was determined to be 5000 mg/kg.

Acute dermal toxicity data

In an acute dermal toxicity study (EPA OPP 81-2), groups of young adult New Zealand White rabbits (5/sex) were dermally exposed to the undiluted test item for 24 hours to 10% of body surface area at a limit dose of 2000 mg/kg bw (Bonnette, 1995; Study No. 3263.85). Animals then were observed for 14 days.

 

Dermal LD50 was determined to be:

Males >2000 mg/kg bw

Females >2000 mg/kg bw

Combined >2000 mg/kg bw

 

No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included transient incidences of fecal stain and dark material around the facial area. Dermal irritation was noted at the site of test article application. Body weight gain was noted for all animals during the test period.Thickened subcutis was noted in 2/10 animals.

 

The test item is of low toxicity and does not trigger classification, the study is classified as acceptable.

Justification for selection of acute toxicity – oral endpoint
best study available

Justification for selection of acute toxicity – dermal endpoint
best study available

Justification for classification or non-classification

Reaction Products of Diphosphorus Pentaoxide with Alcohols, C8-10, salted with Amines, C12-14, Tert-alkyl had LD50 of 5000 mg/kg bw and LD50 greater than 2000 mg/kg bw for acute oral and dermal toxicity, respectively. Inhalation is not a relevant route of exposure. Therefore, the substance does not meet the criteria for classification and labelling for oral, dermal or inhalatory toxicity in accordance with European Regulation (EC) No. 1272/2008.