Phosphoric acid, 2-ethylhexyl ester, sodium salt

Endpoint summary

Description of key information

Studies on acute oral, dermal or inhalation toxicity do not need to be conducted according to REACH Annex VII and VIII Section 8.5, Column 2 since the test item is classified as skin corrosive and severely eye damaging cat 1 according to CLP.

However, based on available studies on acute oral toxicity with the test item at different compositions, i. e. 40 - 46 % water, the LD50 of the tested substance was > 2000, 5000 or 6700 mg/kg bw in rats. This corresponds to a corrected LD50 of at least greater than 2000 mg/kg bw of the substance registered.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Supporting studies with aqueous solutions of the registered substance.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

Since the test item is classified and labelled as corrosive to skin and eye cat 1 according to CLP, no acute oral toxicity study is conducted.

Supporting studies with aqueous solutions of the test item

A study was conducted in 1987 to assess the acute oral toxicity of the test material (aqueous solution with 45 % water) in the rat according to OECD Guideline No 401. Five male and five female Sprague-Dawley CFY strain rats were used. All animals were dosed once only by gavage with a limit dose of 2000 mg/kg bw. The animals were observed for a period of 14 days. As a result, no mortality occurred and no signs of systemic toxicity were noted. Therefore, the LD50 of the tested material was considered to be >2000 mg/kg bw. Since no systemic toxicity or mortality was observed, derivation of a corrected LD50 is not reasonable based on these data.

A study was conducted in 1986 to assess the acute oral toxicity of the test material (conatining 40 % water) in the rat according to OECD Guideline No 401. Five male and five female Sprague-Dawley CFY strain rats were used.

All animals were dosed once only by gavage with a limit dose of 5000 mg/kg bw. The animals were observed for a period of 14 days. As a result, one male animal was found dead. Hunched posture, lethargy, pilo-erection and a decreased respiratory rate was observed in all animals on the day of dosing. Ptosis was also occasionally observed. All surviving animals continued to show hunched posture, lethargy, pilo-erection and a decreased respiratory rate on day one. All surviving animals appeared normal on day two. Therefore, the LD50 of the test material was considered to be >5000 mg/kg bw. Correspondingly, the corrected LD50 (without water) is considered to be > 3000 mg/kg bw for the test item.

Furthermore, an additional study was conducted in 1979 to assess the acute oral toxicity of the test material containing 46 % water in the rat comparable to OECD Guideline No 401. Five male and five Wistar rats were used per dose group (doses: 0, 5, 6.4, 8, 10 mL/kg bw). An additonal control group received water. All animals were dosed once only by gavage. The animals were observed for a period of 14 days. No mortalitiy was observed in the control group. Deaths were observed in all dose groups and the animals exhibited ruffled fur, pale limbs, hunched posture, lacrimation, diarrhea, lethargy and ataxy was observed. Based on mortality, the LD50 was determined to be 6.75 mL/kg bw (corresponding to 7.115 mg/kg bw.

As the tested material has a higher water content (46%) compared to the substance to be registered, it was concluded that the LD50 value for the registered substance is ca. 3600 mg/kg bw.

In conclusion, acute oral toxicity does not need to be tested with the test item because it is classified as skin and eye corrosive. However, studies are available with aqueous solutions of the test item. Based on the results of these studies, corrected LD50 values would be greater than 2000 mg/kg bw in the rat. Therefore, the substance to be registered does not require classification for acute oral toxicity according to CLP.

Acute dermal toxicity

A study was conducted to assess the toxicity of test item when administered in a single dermal dose to rats at one or more defined dose levels.At first, the range-finding study was performed in one female Han:WISTrat. The starting dose was 200 mg/kg bw. The test item was applied in original form and left in contact with the skin for a 24 hours period. The observation period was three days (treatment day as Day 0 and post treatment period as Day 1 and Day 2). The in-life phase was terminated on Day 2 and the study was stopped, because unexpected corrosive signs were found on the treated skin surface. Moderate to severe erythema and other sign as whitish colouration were observed on Day 1, 1 hour after the patch removal. Severe erythema, open wound, crust and necrosis were detected on Day 2. No death and any systemic toxic sign were found. The body weight loss (approx. 4.2 %) was observed between the treatment day and Day 2. External macroscopic changes as open wound, crust and necrosis were found on the treated area of the animal. The test item could not be classified into any toxicity category and was furthermore classified as corrosive to skin (Cat 1B), therefore no further studies on the acute dermal toxicity have to be conducted. No conclusion regarding classification of the substance for acute dermal toxicity can be drawn based on the available study.

Acute inhalation toxicity

Since the test item is classified and labelled as corrosive to skin and ey cat 1 according to CLP, no acute inhalation toxicity study is conducted.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

There are no data available with the substance to be registered on acute systemic toxicity. However, acute oral toxicity studies are available with aqueous solutions of the test item. Based on the results of these studies, corrected LD50 values would be greater than 2000 mg/kg bw in the rat. Therefore, the registered substance does not require classification for acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP).
No conclusion can be made for actue inhalation or dermal toxicity based on the available data.