Isovaleric acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Equivalent to guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isovaleric acid

EC Number:

207-975-3

EC Name:

Isovaleric acid

Cas Number:

503-74-2

Molecular formula:

C5H10O2

IUPAC Name:

3-methylbutanoic acid

Test animals

Species:

rabbit

Strain:

Vienna White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gauckler. D-6050 Offebach
- Weight at study initiation: 2-3 kg
- Fasting period before study: no data
- Housing: in stainles steel cages
- Diet: approx. 130 g/animal and day
- Water: approx. 250 mL/animal and day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

vegetable oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 300 cm²
- Type of wrap if used: semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 5 mL/kg bw
- Concentration (if solution): 40%
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 5 mL/kg bw
- Concentration (if solution): 60%
- Purity: olive oil, DAB 9

Duration of exposure:

24 hrs

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: at least once per day; weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: histopathology of treated skin

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1/6 animals died within 24 hours

Mortality:

One male died during day 1. Necropsy revealed dilatation of the heart and moderate lung edema

Clinical signs:

other: none

Other findings:

One male died during day 1. Necropsy revealed dilatation of the heart and moderate lung edema.

Sacrificed animals: skin: full thickness necrosis; organs: no pathological findings

Applicant's summary and conclusion

Conclusions:

The dermal LD50 was >2000 mg/kg bw in male and female rabbits.

Executive summary:

The acute dermal toxicity of isovaleric acid was determined in White Vienna rabbits (3 per sex; semi-occlusive dressing, exposure period 24 hours; dose 2000 mg/kg bw; vehicle: olive oil) using a protocol that was equivalent to OECD 402. The observation period was 14 days. One male died on day 1, all other animals survived without clinical signs of toxicity. At termination, histopathology revealed full thickness necrosis at all treated sites, moderate lung oedema and heart dilatation in the animal that died, no findings in animals that were sacrificed. Hence, the dermal LD50 was >2000 mg/kg bw in rabbits (BASF, 1990).  

The study is considered to be valid and suitable for assessment.