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Diss Factsheets

Administrative data

Description of key information

Under the conditions of this study, the acute oral approximate lethal dosage (LD50) was:

male: more than 2000 mg/kg

female: more than 2000 mg/kg

Combined sexes: more than 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 25 - Otober 9, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
no guideline available
Principles of method if other than guideline:
Testing carried out prior to OECD guidelines. The acute oral toxicity of the test substance was studied in groups fasted male and female rats of Winstar at a dosage of 2000 mg per kg. The test material was administered on Day 0. Mortality and signs of reaction to treatment were recorded during a 14-day period of observation.
GLP compliance:
not specified
Test type:
other: Single dose method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age: 45 day old
- Weight at study initiation: males: 202 to 221g, females: 155 to 170g.
- Fasting period before study:
- Housing: polycarbonate cages with stainless steel grid tops
- Diet: ad libitum except on the day of dosing
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25°C +/- 3°C
- Humidity (%): 50% +/-10%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle per day

IN-LIFE DATES: From: To:
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
gavage
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The acute oral toxicity of p-Menthan-3,8-diol was studied in groups fasted male and female rats of Winstar at a dosage of 2000 mg per kg. The test material was administered on Day 0. Mortality and signs of reaction to treatment were recorded during a 14-day period of observation.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none observed
Clinical signs:
other: none obeserved
Gross pathology:
none observed
Other findings:
not specified
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the acute oral approximate lethal dosage (LD50) was:
male: more than 2000 mg/kg
female: more than 2000 mg/kg
Combined sexes: more than 2000 mg/kg
Therefore, the test substance can be classifed as relatively harmless.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification