Fatty acids, C16-18, isononyl esters

Endpoint summary

Description of key information

Oral (similar to OECD 401): LD50 > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

Specific details on test material used for the study:

Liquid

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

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

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.

Interpretation of results:

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Value:

> 5 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate, reliable (Klimisch score 2) and consistent study. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

The acute oral toxicity of Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) was assessed in a GLP study comparable to OECD guideline 401 (key study, 1985). Administration of 5000 mg/kg bw to 5 rats per sex via oral gavage did not cause mortality. Reduced activity and piloerection in all 10 animals was observed for 3-8 hours after application. No other abnormalities were recorded during the 14-day observation period. There were no effects on body weight. The acute oral LD50 value in rats was found to be > 5000 mg/kg bw.

Overall conclusion for acute toxicity

The reliable data available for the target substance indicate a very low level of acute toxicity following exposure via the oral route, as the LD50 value were greater than the administered limit values. Therefore, as the available data did not identify any acute toxicity, Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) is not considered to be hazardous following acute exposure.

Justification for classification or non-classification

The available data on acute oral toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.