Phosphoric acid, C16-18-alkyl esters, potassium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-01-17 to 2007-02-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-Octadecanol, phosphate, potassium salt

EC Number:

273-489-3

EC Name:

1-Octadecanol, phosphate, potassium salt

Cas Number:

68987-29-1

Details on test material:

Name of test material (as cited in study report): Silastol H 200
- CAS No.: 68987-29-1

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, 0-97633 Sulzfeld
- Weight at study initiation: 164 g - 176 g.
- Fasting period before study: overnight prior to dosing
- Housing: Macrolone cages type 3 (2-3 per cage)
- Diet (e.g. ad libitum): Altromin 1314, Altromin GmbH, 0-32791 Lage, Lippe ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): air changes 10 times/ hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Sighting study: 1 female
main study: 4 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was observed 30 min., 2, 4 and 6 hours after the administration and thereafter daily. Body weight was recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes; all rats were killed by inhalation of CO2 on day 14 and subjected to a gross necropsy examination.
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

The animal included in the sighting study survived the treatment and showed slight signs of toxicosis, piloerection was observed 30 minutes, 2, 4 and 6 hours after the application of the test item.
The post mortem inspection revealed no pathological abnormalities.

Effect levels

Sex:

female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the female rats died.

Clinical signs:

other: They did not show marked signs of toxicosis. Piloerection was observed 30 minutes and 2 hours after the application of the test item, whereas normal behaviour was observed after 4 and 6 hours. From day 1 to the end of the observation period on day 14 no a

Gross pathology:

The gross necropsy of the animals revealed no pathological abnormalities.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP; EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The oral LD50 females was determined to be > 2000 mg/kg bw.

Executive summary:

The acute oral toxicity in rats was determined according to the method recommended in the OECD Guideline No. 420, "Acute Oral Toxicity - Fixed Dose Procedure", December 2001, and the commission directive 2004/73/EC "B.1 bis Acute Oral Toxicity: Fixed Dose Procedure", April 2004.

 

The study was initiated with a sighting study, in which one female rat was given SILASTOL H 200 in a 2000 mg/kg b.w. dose. Slight signs of toxicosis (piloerection) were observed in this rat. Based on the results from the sighting study, the main study was carried out with four more female animals each given a dose of 2000 mg/kg b.w.

All animals in the main study survived the treatment, weight gain was normal and apart from piloerection no other clinical signs were observed. The gross necropsy of the animals revealed no pathological abnormalities.

The oral LD50 females was determined to be > 2000 mg/kg bw.