Isopulegol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-GLP, pre-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Principles of method if other than guideline:

no data

GLP compliance:

no

Remarks:

pre-GLP-study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isopulegol

EC Number:

201-940-6

EC Name:

Isopulegol

Cas Number:

89-79-2

Molecular formula:

C10H18O

IUPAC Name:

isopulegol

Details on test material:

Isopulegol; no further data
Test Sample: RIFM 71-47 (5-11-71)
Clear liquid in a 4 ounce bottle

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.4-2.8 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Type of wrap if used: dental dam binders with gauze and adhesive binder
- intact or abraded skin, 2 animals per dose group each

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

Duration of exposure:

24 hours

Doses:

ca. 1140, 2275, 4550, 9090 mg/kg bw (1.25, 2.5, 5, 10 ml/kg bw)

No. of animals per sex per dose:

2 males and 2 females per dose group

Control animals:

no

Details on study design:

- Duration of observation period following administration: daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight (initial and at day 14), dermal irritation scoring acc. to Draize (after binder removal and daily thereafter for a total of 14 days)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 5 mL/kg bw

Remarks on result:

other: approx. 4550 mg/kg bw

Mortality:

10 ml/kg bw: 4/4
5 ml/kg bw: 1 (abraded)/4
2.5 ml/kg bw: 0/4
1.25 ml/kg bw: 0/4

Clinical signs:

other: 10 ml/kg bw: ataxia and lacrimation in 2 females 5 ml/kg bw: ataxia in 3 rabbits 2.5 ml/kg bw: ataxia in 1 unabraded female 1.25 ml/kg bw: no effects

Gross pathology:

Stomach hyperemia, post mortem change, dehydration and hemorrhage (dermis, epidermis)

Any other information on results incl. tables

Data on the LD50 are inconsistent in the study report. The LD50 has been reported to be approx. 3 ml/kg, which is incosistent with the mortality findings observed, i.e. mortality in 1/2 abraded rabbits in the 5 ml/kg dose group.