Isooctadecanoic acid, mixed esters with oxybis[propanediol]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

17 September - 2 October 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no analytical purity reported

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted in 1987

Deviations:

yes

Remarks:

no analytical purity reported

GLP compliance:

yes (incl. QA statement)

Remarks:

Bezirksregierung, Lüneburg, Germany

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

130905-60-1

EC Number:

603-445-4

Cas Number:

130905-60-1

IUPAC Name:

130905-60-1

Test animals

Species:

rat

Strain:

other: Crl.: (WI) BR - Wistar, white

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Weight at study initiation: 268 – 293 g (males); 208 – 228 g (females)
- Fasting period before study: animals were fasted from 16 h before until 3 - 4 h after administration of the test article
- Housing: 5 animals of the same sex per cage in Macrolon cages type III
- Diet: Ssnif-R Alleindiät, pellets
- Water: drinking water supplied in drinking bottles, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 – 85 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined for clinical signs at the following time point after administration: 10 min, 1 h, 2 h, 6 h, 24 h, and thereafter once daily up to day 14. Individual body weights were determined weekly: on days 0 (before treatment), 7 and 14 (termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, grosspathology

Statistics:

LD 50 values were calculated according to Finney D. Y., Probit Analysis, 3rd edition, Cambridge, 1971

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period

Clinical signs:

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

Body weight:

No effect on body weight was noted

Gross pathology:

Necropsy examination revealed no substance-related findings

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.