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Diss Factsheets

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

Constituent 1
Chemical structure
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:
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
Body weight:
No data were reported.
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.

Applicant's summary and conclusion