Fatty acids, C16-18, isononyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 Jun - 20 Aug 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Limited report details, no test substance purity reported

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted in 1981

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18, isononyl esters

EC Number:

292-960-4

EC Name:

Fatty acids, C16-18, isononyl esters

Cas Number:

91031-57-1

Molecular formula:

not available - multi constituent substance

IUPAC Name:

Fatty acids, C16-18, isononyl esters

Test material form:

liquid

Specific details on test material used for the study:

Liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: mean BW on the day of application, prior to application: 176 g in males, 160 g in females
- Fasting period before study: fasted for 16 h prior application and 3 h after application
- Housing: Makrolon 3 cages with soft wood granulate
- Diet: Altromin Haltungsdiät 1324, Altromin, Lage, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): approx. 45-60
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Remarks:

Oleum Arachidis DAB 7 (Lamotte, Bremen, Germany)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% (g/v)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of clinical observations: several times on the day of application, and thereafter twice daily throughout the 14 days of observation
- Frequency of mortality recording: 1, 2, 7, and 14 days after application
- Frequency of weighing: prior to and 2, 7, 14 days after application
- Necropsy of survivors performed: yes, after euthanasia using ether

Statistics:

Not required

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the observation period.

Clinical signs:

other: Reduced activity and piloerection was observed in all 10 animals for 3-8 hours after application.

Body weight:

other body weight observations

Remarks:

Mean body weights increased in males as well as in females.

Gross pathology:

No abnormal 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.