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EC number: 203-602-3
CAS number: 108-64-5
The test item has a low acute toxicity
by the oral and dermal route.
In rats, the LD50 value via the oral
route is > 5000 mg/kg bw (value derived from Read -across compound 3
-methylbutyl isovalerate). In consideration of the molecular
weight of both substances (172.27 and 130.18 g/mol), the corrected LD50
for Ethyl isovalerate is > 3778.66 mg/kg.
In rats, the LD50 value via the dermal
route is > 2000 mg/kg bw (value derived from Read -across compound ethyl
propionate). In consideration of the molecular weight of both substances
(102.13 and 130.18 g/mol), the corrected LD50 for the target substance
No abnormalities were observed during
1: Summary of Mortality
Step / Dose (mg/kg)
No. of animals
Days after dosing
Step 1/ 5,000
Step 2/ 5,000
2: Individual Clinical Signs
Hours (Day 0) after dosing
No observable abnormality
Table 3. Individual Body Weights
0 ~ 14
Table 4. Individual Body Weights
during an Acclimation Period
Temporary Animal ID
of this study was to assess the potential toxicity of the test substance
following a single oral dose administration to female Sprague-Dawley
rats and to classify the test substance under GHS classification.
groups were designed as Steps 1 and 2 at 5,000 mg/kg. Step 1 consisted
of one female and Step 2 consisted of two females. All animals were
monitored for clinical signs and body weight changes during the 14-day
observation period after administration. They were subjected to gross
necropsy at the end of the observation period.
no deaths of animals at 5,000 mg/kg. Mucous stool was observed in an
animal on Day 1 after dosing and it disappeared on Day 2 after dosing. A
tendency to suppress body weight gain was observed in animals on Day 1
after dosing. Then, these animals returned to normal on Day 3. No test
substance-related effects were observed in necropsy findings in any
on the result of the acute oral toxicity study in Sprague-Dawley rats,
the test substance was not classified according to the GHS
classification and the median lethal dose derived was: LD50
cut off> 5,000
The acute dermal toxicity of the target
substance was predicted from the source substance (see read-across
justification). In an acute dermal toxicity study the LD50 for the
source substance was >2000 mg/kg bw in rats. In consideration of the
moleculoar weight of both substances (130.18 and 102.13 g/mol), the
corrected LD50 value for the target substance is >2549 mg/kg bw.
Therefore, using a read-across approach, the target substance was not
classified under CLP classification.
In the supporting acute oral toxicity
studies in rats using the test substance, an LD50 of >5000 mg/kg bw was
determined. In the supporting acute dermal toxicity study an LD50 of
>5000 mg/kg bw in rabbits was determined.
Based on the available results, the test
substance is not classified for acute oral and dermal toxicity according
to Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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