Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05.02.2004 to 16.03.2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to the OECD guideline 425 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
OS Menthol Ester
IUPAC Name:
OS Menthol Ester
Constituent 2
Chemical structure
Reference substance name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
EC Number:
604-569-1
Cas Number:
147126-62-3
Molecular formula:
C14H24O4S
IUPAC Name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
Test material form:
other: White solid

Test animals

Species:
rat
Strain:
other: CD(R)[Crt:CD(R)(SD)BR]
Sex:
female
Details on test animals or test system and environmental conditions:
- Age at study initiation: X days (at study initiation / at test item administration)
- Weight at study initiation: females 200-300 g
- Fasting period before study: overnight
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 23 days
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1% methyl cellulose in water
Details on oral exposure:
The animals were dosed at 2000.0 mg/kg (10.0 mL/kg by volume). The individual doses of the test article preparation were individually calculated for each animal based on the body weight of the animal. All doses were administered orally using a feeding needle, inserted into the stomach of the animals.
Doses:
The individual doses of the test article will be individually calculated for each animal based on the body weight of the animal. All doses will be administered orally using No. 6 infant feeding cannula or feeding needle, inserted into the stomach of the animals. The maximum dose volume will not exceed 2 mL/100 g
for aqueous solutions, or 1 mL/1 00 g for non aqueous solutions.
No. of animals per sex per dose:
5 female rats at 2000 mg/kg
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at 0.5 and 4 h after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 day 13 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy, organ weights, histopathology
Statistics:
Not applicable due to no mortalities.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortalities at 2000 mg/kg bw
Mortality:
No mortalities were observed during the 14-day post treatment observation period.
Clinical signs:
No signs of toxicity were recorded during the 14-day post treatment observation period.
Body weight:
Mean Group Weight (g)± S.D. (g); n = 5
Initial: 255.9 ±22.7
Day7: 274.6 ± 21.6
Day13: 291.8 ± 22.4
Day14: 293.5 ±22.6
Gross pathology:
Each animal was sacrificed at the end of the 14-day observation period, and full gross necropsy was performed. No gross pathological findings were observed at the time of necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information > 2000 with no deaths or evident toxicity Criteria used for interpretation of results: EU
Conclusions:
Based on the foregoing results, the acute oral LD50 in rats of the test article, OS Menthol Ester was found to be in excess of 2000.0 mg/kg.
Thus, the test article is considered not to present a sigoificant acute toxic risk if swallowed.
The Globally Harmonized Classification System for Chemicals and Mixtures classifies compounds in which the estimated LDso is greater than 2000.0 mg/kg with no deaths or evidence of toxicity as being Category 5 chemicals.
Executive summary:

As no mortalities were observed in female rats orally dosed at 2000 mg/kg bw the substance was not classified.