Sorbitan, octanoate (2:3)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 Aug - 30 Aug 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

98144-53-0

IUPAC Name:

98144-53-0

Details on test material:

- Name of test material (as cited in study report): Sorbitansesquioctanoate
- Substance type: organic
- Physical state: amber liquid
- Analytical purity: no data
- Lot/batch No.: ES 65631498

Test animals

Species:

rat

Strain:

other: White Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: about 8 weeks
- Weight at study initiation: 150.2 - 164.8 g
- Fasting period before study: overnight
- Housing: Three rats were housed in one Makrolon cage type VI each. A non-barrier system with air condition was used.
- Diet: Type 1324 (batch 1138), supplied by: Altromin International, Lage, Germany. After test substance application food was withheld for 3-4 hours, then ad libitum
- Water: normal tap water from municipal sources (Staedtische Werke Krefeld AG, Krefeld, Germany) ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: average 0.31 mL/157.5 g
CLASS METHOD:
- Rationale for the selection of the starting dose: Significant acute oral toxicity of the test substance was not expected. Therefore, the limit-dose of 2,000 mg/kg bw was chosen.

Doses:

2,000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations immediately, 1 h and 3 h or 4 h, after test substance administration and daily thereafter, weight development was measured after 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Clinical examination was performed immediately, 1 h and 3 h or 4 hours, after test substance administration and daily thereafter. Toxic signs were recorded with respect to severity, time onset and duration.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

The necropsy 14 days after oral application showed no substance related morphological visible pathologic organ findings.

Any other information on results incl. tables

Table 1: Body weights of female rats treated with 2000 mg/kg bw of the test substance.

Animal ID	Day 0 [g]	Mean ± SD [g] Day 0	Day 7 [g]	Mean ± SD [g] Day 7	Day 14 [g]	Mean ± SD [g] Day 14	Average weight gain
425 lv	153.5	157.5(± 5.8)	184.7	188,0(± 9.7)	198.3	202.1(± 8.9)	+ 28.3 %
425 rv	157.3		183.2		196.0
425 lh	155.5		192.7		204.8
426 lv	163.8		202.0		214.1
426 rv	164.8		191.6		209.3
426 lh	150.2		173.7		190.2

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified