2-Propylheptyl octanoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-06-20 to 2006-10-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-study according to OECD test guideline 402

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

February 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation, India
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation:Male : Minimum: 283, Maximum: 298, Female : Minimum: 237, Maximum: 266
- Fasting period before study: no
- Housing: individually in polypropylene rat cages covered with stainless steel grid tops
- Diet: Rat pellet feed (Amrut brand), was provided ad libitum
- Water: Drinking water filtered through an Aquaguard water filter system was provided ad libitum.
- Acclimation period: 6 days prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature: :19 to 23 °C
- Humidity: 64 to 67 %
- Air changes: minimum 15 air changes/h
- Photoperiod: photoperiod was 12 h artificial light and 12 h darkness, light hours being 06:00 h -18:00 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 10% of body area
- Type of wrap if used: porous gauze dressing and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: cotton moistened with distilled water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2, 3 and 6 hours post dermal application on day 0; from day 1 twice/day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

none

Body weight:

comparable gain in treated and control group

Gross pathology:

no findings in treated group