Halophosphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 7, 2010 - February 21, 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has been performed in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(2001)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(2008)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

(2002)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): F10Fine
- Physical state: colourless solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation:
Step 1/animals no. 1-3: 147-159 g
Step 2/animals no. 4-6: 150-166 g
- Fasting period before study: 16 to 19 hours
- Housing: the animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 040810)
- Diet: free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1013). Free access again from 4 hrs post dosing.
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Date of Dose Administration:
Step 1, animals no. 1, 2 and 3: December 22, 2010
Step 2, animals no. 4, 5 and 6: December 29, 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.4 g/mL
- Amount of vehicle: 5 mL
- Justification for choice of vehicle: due to its non-toxic characteristics
- Lot/batch no.: Sigma, lot no. MKBB7604, expiry date 30/01/2011
- Purity: not applicable

DOSE VOLUME APPLIED: 5 mL/kg

DOSAGE PREPARATION: the test item was weighed out into a tared plastic vial on a precision balance. Homogeneity was maintained by vortexing. The dosages were made shortly before administration.

CLASS METHOD
- Rationale for the selection of the starting dose: no details provided

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 females twice (6 females in total)

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: the animals were weighed on day 1 (prior to the administration), on day 8 (1 week thereafter) and on day 15 (2 weeks thereafter)
- Frequency of observations: a careful clinical examination was made several times on the day of dosing (at least once during the 1st 30 minutes and with special attention given during the 1st 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. According to the OECD Guideline.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortalities occurred

Mortality:

- No mortalities occurred

Clinical signs:

other: - At 3 and 4 hours after administration, slight to moderate reduced spontaneous activity, prone position and piloerection was observed in the 3 animals of the 1st group, until day 2 - No other signs were observed in any of the animals at any observation t

Gross pathology:

- No abnormalities were observed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study in female rats, conducted in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles, a LD50 oral of >2000 mg/kg was determined.

Executive summary:

The acute oral toxicity in female rats has been studied in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles. The substance was dosed in cotton seed oil at 2 g/kg bw in 6 female rats, in 2 steps. At 3 and 4 hours after administration, slight to moderate reduced spontaneous activity, prone position and piloerection was observed in the 3 animals of the 1st group, until day 2. No mortalities occurred. Necropsy did not show any abnormality. The acute oral toxicity (LD50) was determined to be >2000 mg/kg. Based on this result, the substance does not need to be classified for acute toxicity by the oral route.