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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
other: No signs of toxicity were recorded during the 14-day post treatment observation period.
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.