Phosphoric acid, dodecyl ester, potassium salt

Endpoint summary

Description of key information

Acute toxicity after single oral application was tested in female rats, which received up to 15,000 mg/kg bw. Five females out of ten died at 10,000 mg/kg bw, 9 at 12,500 mg/kg bw and all animals at 15,000 mg/kg bw. Observed clinical signs were vomiting and spasm. The necropsy of the deceased females did only reveal local effects in the stomach. These findings are considered to be attributed to the 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 10,490 mg/kg bw. Due to the findings described above (LD50 oral in rats 10,490 mg/kg bw) Phosphoric acid, dodecyl ester, potassium salt does not have to be classified as acute orally toxic.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Sept 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Equivalent to OECD401; performed before GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

only one sex tested, limitations in study reporting

GLP compliance:

no

Remarks:

performed before GLP guidelines

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Hoe WISKf(SPF71)
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 90-112 g (female); (mean = 100 g; n = 60)
- Age at study initiation: no data
- Fasting period before study: 16 hours before and 2 hours after application
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water: Tap water ad libitum
- Acclimatization period: no data

ENVIRONMENTAL CONDITIONS
- Housing: in groups, in plastic cages, softwood pellets

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- concentration in vehicle: 25 % (w/v)

Doses:

6300 mg/kg
8000 mg/kg
9000 mg/kg
10000 mg/kg
12500 mg/kg
15000 mg/kg

No. of animals per sex per dose:

10 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations after application / Weighing once weekly
- Necropsy of survivors performed: yes

Statistics:

Probit analysis (method by Linder and Weber);
Confidence limits according to Cavalli-Sforza

Preliminary study:

Preliminary experiments did not show differences related to gender. Therefore only females used for main study.

Sex:

female

Dose descriptor:

LD50

Effect level:

10 490 mL/kg bw

95% CL:

> 9 833 - <= 11 191

Mortality:

Sex: female, Dose: 6300 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 8000 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 9000 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 10000 mg/kg bw, Mortality rate: 5 / 10
Sex: female, Dose: 12500 mg/kg bw, Mortality rate: 9 / 10
Sex: female, Dose: 15000 mg/kg bw, Mortality rate: 10 / 10

Clinical signs:

other: Mortally poisened animals died within 1-2 days after application. Following symptoms were observed: disturbance of equilibrium, spasm. The test substance was vomitted.

Gross pathology:

Dissection of rats killed at the end of the observation period revealed no macroscopic findings.
Necropsy of the deceased animals revealed following macroscopic findings: Stomach and oesophagus were filled with white foam.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of the test item (LD50) was 10490 mg per kg body weight. Based on the result of this study the test item is not subject for labelling and classification requirements according to regulatory requirements.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 490 mg/kg bw

Quality of whole database:

2 (reliable with restrictions)

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

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:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Based on the results of an oral toxicity study the LD50 value for acute oral toxicity was calculated to be 10,490 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, dodecyl ester, potassium saltdoes not exert systemic toxic effects after acute inhalation exposure and thus does not have to be classified, because

- the LD₅₀value for acute oral toxicity of Phosphoric acid, dodecyl ester, potassium salt is 10,490 mg/kg bw, and

- exposure of humans via inhalation is considered unlikely taking into account the vapour pressure and the physical form (pasty) of the substance.

Therefore, it is concluded that testing of acute inhalation toxicity of of Phosphoric acid, dodecyl ester, potassium salt is not scientifically necessary.

It can reasonably be deduced that Phosphoric acid, dodecyl ester, potassium salt 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 a single oral dose of up to 9,000 mg/kg bw in rats. Due to the combination of its polar (ionic) character and the long extent of the alcoholic chain 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 15,000 mg/kg bw/d) will be systemically available via the 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
The study performance is equivalent to OECD401; study performed before GLP.

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 10,490 mg/kg bw) Phosphoric acid, dodecyl ester, potassium salt does not have to be classified as acute orally toxic. Based on the substance's physico-chemical properties no higher systemical exposure via inhalation or dermal penetration is expected to occur than that tested in the course of the oral toxicity study. Therefore, Phosphoric acid, dodecyl ester, potassium salt does not have to be classified as acute toxic.