Nonanoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (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:

Nonanoic acid

EC Number:

203-931-2

EC Name:

Nonanoic acid

Cas Number:

112-05-0

Molecular formula:

C9H18O2

IUPAC Name:

nonanoic acid

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Pelargonsäure
- Substance type: organic acid
- Physical state: liquid
- Analytical purity: 93% C9 fatty acid
- Lot/batch No.: 799800

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: mean males: 275 g; females: 176
- Fasting period before study: max. 20 hours
- Housing: in groups of 3
- Diet: ad libitum starting at 4 hours after dosing
- Water: tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/10 mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: based ob results of a pretest


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw


DOSAGE PREPARATION: purity of test substance was taken in to account. formulations (w/w) were prepare dwithin 4 hours prior to dosing.


CLASS METHOD
- Rationale for the selection of the starting dose: limit dose 2000 mg/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: twice daily. Weighing: days 1 (pre-treatment), 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not needed

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred

Clinical signs:

other: Lethargy and uncoordinated movements were seen on days 1 and/or 2. Piloerection in one female on day 1.

Gross pathology:

No abnormalities seen at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: GHS critertia under EU CLP (1272/2008/EC) not met

Conclusions:

The oral LD50 was >2000 mg/kg bw in male and female rats.

Executive summary:

The acute oral toxicity of pelargonic acid was examined in Wistar rats (3/sex) in a toxic class study, performed according to OECD guideline 423 and under GLP conditions. All animals survived the 14-day observation period following the administration of 2000 mg/kg bw by oral gavage. Clinical signs of toxicity were limited to slight to moderate lethargy and uncoordinated movements on the treatment day and/or the following day. Body weights were not affected, and there were no abnormalities at necropsy after sacrifice on day 15. The acute oral LD₅₀ was therefore >2000 mg/kg bw in rats (NOTOX, 2001).