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Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
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

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:
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 abnormalities
were revealed.
Body weight:
The rats had a normal body weight gain during the study period.
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.

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