Nonanoic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

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. 10 weeks
- Weight at study initiation: mean males: 369 g; females: 239 g
- Housing: singly
- Diet: standard laboratory diet ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-3
- Humidity (%): 30-70
- Air changes per hour: 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: males 25 cm², females 18 cm²,
- % coverage: 10% of body surface
- Type of wrap if used: surgical gauze, covered with aluminium foil and flexible bandage


REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was removed using a tissue moistened with water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Constant volume or concentration used: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): apporx. 8 mL/kg bw
- Concentration (if solution): approx. 80%

Duration of exposure:

24 hours

Doses:

2000 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 observations and weighing: observations: 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

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality occurred

Clinical signs:

other: Hunched posture in all treated animals up to day 4. Skin reactions: general erythema, scales and scabs were noted in all animals. Grades 1 and 2 (slight, moderate) prevailed. In 6 of 10 animals, skin reactions persisted until the end of the observation pe

Gross pathology:

No findings noted

Any other information on results incl. tables

Skin: not examined histopathologically

Applicant's summary and conclusion

Interpretation of results:

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

Executive summary:

The acute dermal toxicity ofpelargonicacid (2000 mg/kgbw) was examined in Wistar rats (5/sex) according to OECD guideline 423 and under GLP conditions. All animals survived the 14-day observation period following the application of 2000 mg/kgbw. Clinical signs of toxicity were hunched posture on the treatment day and the following three days, and skin reactions which were seen in all treated animals. The skin reactions were general erythema, scales and scabs of the treated skin, generally of slight to moderate grade. In 6 of 10 animals, skin reactions persisted until the end of the observation period on day 15. Body weights were not affected, and there were no abnormalities at necropsy after sacrifice on day 15. The acute dermal LD₅₀ was therefore >2000 mg/kg bw in rats (NOTOX, 2001).