Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2/3 to 17/3 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: similar to guideline study, non-GLP and no individual data reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-menthane
- Physical state: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
-Strain: Wilmslow Wistar
-Source: Harlan Winkelmann GmbH, 33167 Borchen
- Age at study initiation: young adults
- Weight at study initiation: average 153 g
- Fasting period before study: 16 hours before application
- Housing: 5 animals/macrolon III cage
- Diet: R10 allein diät Ssniff laboratory rat feed ad libitum
- Water: ad libitum
- Acclimation period: 5-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 60±5%
- Air changes (per hr):15/hr
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02-03-1989 To: 17-03-1989

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: NA

MAXIMUM DOSE VOLUME APPLIED: 3.75 cm3/kg bw

Doses:
3000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: until 6 hours and daily thereafter
Body weight:on day 0, 1, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: macrocopic investigations
Statistics:
NA limit test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
ventro-lateral recumbency, piloerection and diarrhea in males during first 24 hours.
Thereafter no observations
Body weight:
within normal ranges
Gross pathology:
thinkening of the forestomach mucosa

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 in rats is > 3000 mg/kg bw
Executive summary:

In a limit test rats received 3000 mg/kg bw of the test substance. No mortality occurred. The LD50 is > 3000 mg/kg bw.