Decyl dihydrogen phosphate, potassium salt

Endpoint summary

Description of key information

The available study on decyldihydrogenphosphate, potassium salt (CAS: 68427 -32 -7) is performed pre-GLP and before OECD guideline was available. It has been evaluated as Klimish rating 2 due to the limited reported study with basic data performed comparable to guideline/standard.

 

In the full scale test, rats were administered 1.0 to 6.4 ml/kg bodyweight of the tested product consisting of 45% decyldihydrogenphosphate, potassium salt (CAS: 68427 -32 -7). Rats treated with water alone (6.4 ml/kg ) served as controls. Based on the identified specific density of the substance (CAS no 68427-32-7) of 1.44 g/ml as given under section 4.4 in IUCLID, the LD50 value will be between 2000 – 5000 mg/kg bw and thereforenot to be classified for acute toxicity according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.

 

During the observation period of 14 days, a record was kept of all mortalities and signs of toxicity. Signs of reaction to treatment, observed shortly after dosing, included lethargy and piloerection. These signs were accompanied by a slight increase in salivation in rats treated at 2.5 ml/kg and above and later by slight ataxia in female rats treated at 2.5 ml/kg and all rats at 4.0 and 6.4 ml/kg. Death occurred between two and ten hours after treatment. Autopsy revealed slight to moderate haemorrhage of the stomach and small intestines, and slight injection of mesenteric blood vessels. Slight darkening of the liver and kidneys was observed in four rats. Recovery of survivors, as judged by external appearance and behaviour, was apparently complete within 5 days of treatment. This observation was substantiated by normal bodyweight gains compared with controls, and normal autopsy findings. The acute median lethal oral dose (LD50) to rats of the tested product consisting of 45% a.s. was calculated to be: 5.7 mg/kg bodyweight. The corresponding LD50 value Decyldihydrogenphosphate, potassium salt (CAS: 68427 -32 -7) is estimated to 2592 mg/kg bw based on concentration.

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:

October-November 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited reported study with basic data given comparable to guideline/standard.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Test was carried out before OECD guideline was available

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Species:

rat

Strain:

other: CFY

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no info
- Age at study initiation: no info
- Weight at study initiation: 95-120 g
- Fasting period before study: overnight
- Housing: no info
- Diet (e.g. ad libitum): no info
- Water (e.g. ad libitum): no info
- Acclimation period: no info


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no info
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info


IN-LIFE DATES: October-November 1974

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: not used

MAXIMUM DOSE VOLUME APPLIED: 6.4 mL/kg bw

DOSAGE PREPARATION (if unusual): no info

Doses:

RF test: 0, 0.4, 1.6 and 6.4 mL/kg bw
Main test: 0, 1.0, 1.6, 2.5, 4.0 and 6.4 mL/kg bw

No. of animals per sex per dose:

RF test: 2 (total of 16 rats)
Main study: 5 (total of 60 rats)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no info
- Necropsy of survivors performed: yes

Statistics:

LD50 and 95% confidence intervals were calculated by the method of Weil CS (1952) Biometrics, 8, 249

Preliminary study:

See below

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 - < 5 000 mg/kg bw

Mortality:

See data below
Death occurred between two and ten hours after treatment.

Clinical signs:

other: Signs of reaction to treatment, observed shortly after dosing, includcd lethargy and piloerection. These signs were accompanied by a slight increase in salivation in rats treated at 2.5 ml/kg and above and later by slight ataxia in female rats treated at

Gross pathology:

Autopsy of deceased animals revealed slight to moderate haemorrhage of the stomach and small intestines, and slight injection of mesenteric blood vessels. Slight darkening of the liver and kidneys was observed in four rats. In survivors, autopsy findings were normal.

Other findings:

None

RF test - mortality M / F

0 ml/kg: 0/2 & 0/2

0.4 ml/kg: 1/2 & 0/2 (25%)

1.6 ml/kg: 0/2 & 0/2

6.4 ml/kg: 2/2 & 2/2 (100%)

Main study: mortality M / F

0 ml/kg: 0/5 & 0/5

1.0 ml/kg: 0/5 & 0/5

1.6 ml/kg: 0/5 & 0/5

2.5 ml/kg: 1/5 & 1/5 (20%)

4.0 ml/kg: 3/5 & 2/5 (50%)

6.4 ml/kg: 3/5 & 5/5 (80%)

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The LD50 value of 4.1 mL/kg in rats of the tested product consisting of 45% a.s. and the specific density of the substance decyldihydrogenphosphate, potassium salt (CAS no 68427-32-7) of 1.44 g/ml as given under section 4.4 in IUCLID, together with the stated concentration of 45%, the LD50 value of decyldihydrogenphosphate, potassium salt (CAS: 68427 -32 -7) will be 2000 - 5000 mg a.i./kg bw.

Executive summary:

Rats of the CFY strain were starved overnight before treatment with the tested product consisting of 45% decyldihydrogenphosphate, potassium salt (CAS: 68427 -32 -7). The tested product consisting of 45% decyldihydrogenphosphate, potassium salt (CAS: 68427 -32 -7) was administered undiluted, by oral intubation at a dosage volume in the full scale test of 1.0 to 6.4 ml/kg bodyweight. Rats treated with water alone (6.4 ml/kg ) served as controls.

During the observation period of 14 days, a record was kept of all mortalities and signs of toxicity. Signs of reaction to treatment, observed shortly after dosing, included lethargy and piloerection. These signs were accompanied by a slight increase in salivation in rats treated at 2.5 ml/kg and above and later by slight ataxia in female rats treated at 2.5 ml/kg and all rats at 4.0 and 6.4 ml/kg. Death occurred between two and ten hours after treatment. Autopsy revealed slight to moderate haemorrhage of the stomach and small intestines, and slight injection of mesenteric blood vessels. Slight darkening of the liver and kidneys was observed in four rats. Recovery of survivors, as judged by external appearance and behaviour, was apparently complete within 5 days of treatment. This observation was substantiated by normal bodyweight gains compared with controls, and normal autopsy findings. The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of of the tested product consisting of 45% decyldihydrogenphosphate, potassium salt (CAS: 68427 -32 -7) were calculated to be: 4.1 (3.1 to 5.5) ml/kg bodyweight.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 592 mg/kg bw

Quality of whole database:

The available data is considered to be of sufficient quality.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The conclusion from the available study is that Decyldihydrogenphosphate, potassium salt (CAS: 68427 -32 -7) is not to be classified for acute toxicity according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.