Phosphoric acid, mixed esters with Bu alc. and ethylene glycol

Endpoint summary

Description of key information

Acute toxicity after single oral application was tested in female rats, which received up to 5,000 mg/kg bw. Two females out of ten died at 3,200 mg/kg bw, 8 at 4,000 mg/kg bw and all animals at 5,000 mg/kg bw. Observed clinical signs were closed eye lid, abnormal breathing, and crouched posture. The necropsy of the deceased females did only reveal local effects in the stomach. These findings are considered to be attributed to the (mucosa )irritant properties of the test substance and are not considered to be of systemically nature. The LD50 value for acute oral toxicity was calculated to be 3575 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:

3 575 mg/kg bw

Quality of whole database:

1 (reliable without restrictions)

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Based on the results of an oral toxicity study the LD₅₀value for acute oral toxicity was calculated to be 3575 mg/kg bw.
In accordance with REACH “Column 2” in Annex VIII there is sufficient weight of evidence from several independent sources of information leading to the conclusion thatPhosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol does not exert systemic toxic effects after acute inhalation exposure and thus does not have to be classified, because

- the LD₅₀value for acute oral toxicity ofPhosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol is 3575 mg/kg bw, and

- exposure of humans via inhalation is considered unlikely taking into account the vapour pressure of the substance.

With reference to its strong eye irritant properties the only effect to be expected after inhalative exposure would local irritation of the respiratory mucosa.

Therefore, and for animal welfare reasons, it is concluded that testing of acute inhalation toxicity ofPhosphoric acid, mixed esters with Bu.Alc. and Ethylene glycolis not scientifically necessary.
It can reasonably be deduced that Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol does not exert systemic toxic effects after dermal application and thus does not have to be classified, because this substance did not cause lethal effects after administration of single oral doses up to 2,500 mg/kg bw in rats (LD₅₀: 3575 mg/kg bw). Due to its polar (ionic) character and its poor lipophilicity (log P_OW: -0.8) the penetration into the stratum corneum will be limited (please refer to Guidance on information requirements and chemical safety assessment, Chapter R.7c, p.157) and therefore, it is unlikely that higher amounts (limit dose of dermal toxicity testing according OECD 402: 2,000 mg/kg bw/d) than tested in the acute oral toxicity study (tested up to 5,000 mg/kg bw/d) will be systemically available via the intact skin barrier even if the most unlikely amount of 100% penetration is assumed. Therefore, testing is not scientifically necessary.

Justification for selection of acute toxicity – oral endpoint
Study design equivalent to OECD Guideline 401 with sufficient reporting.

Justification for selection of acute toxicity – inhalation endpoint
n.a.

Justification for selection of acute toxicity – dermal endpoint
n.a.

Justification for classification or non-classification

Due to the findings described in the acute oral toxicity study (LD50 oral in rats 3575 mg/kg bw) Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol does not have to be classified as acute orally toxic. Based on the substance's physico-chemical properties no higher systemically exposure via inhalation or dermal penetration is expected to occur than that tested in the course of the oral toxitiy study. Therefore, Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol does not have to be classified as acute toxic.