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EC number: 202-598-0 | CAS number: 97-64-3
- Life Cycle description
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Ethyl lactate
- EC Number:
- 202-598-0
- EC Name:
- Ethyl lactate
- Cas Number:
- 97-64-3
- Molecular formula:
- C5H10O3
- IUPAC Name:
- ethyl 2-hydroxypropanoate
- Test material form:
- liquid
- Remarks:
- colorless transparent liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Doses:
- The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality wasobserved during 24 hours (one animal died) and therefore,after another 24 hours,3 females were treated at the same dose.
- No. of animals per sex per dose:
- The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality wasobserved during 24 hours (one animal died) and therefore,after another 24 hours,3 females were treated at the same dose.
Results and discussion
- Preliminary study:
- The test item Ethyl lactate administered to 6 females at a limit dose of 2000 mg/kg body weight caused death of two animals. Piloerection was observed during the observation period.The body weights of the rest animals increased during the study. No body weight losses were observed between the first and second week after administration. During necropsy, no macroscopic findings were observed.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- 2
Any other information on results incl. tables
4/6 animals survived the limit dose of 2000 mg/kg body weight.
Sex |
Dose |
ID |
Result |
Sex |
Dose |
ID |
Result |
♀ |
2000 mg/kg |
1 |
alive |
♀ |
2000 mg/kg |
4 |
alive |
2 |
dead |
5 |
dead |
||||
3 |
alive |
6 |
alive |
Test item-related mortality was observed within24 hours. Animals No 2 and No 5 died day after administration of the test item.Animal No 5 died probably during the night hours, because cadaver was in a state of autolysis.
Table3Body Weight
Sex |
Dose |
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
Initial |
Week 1 |
Week 2 |
Week 1 - Initial |
Week 2 - Initial |
Week 2 - Week 1 |
|||
♀ |
2000 mg/kg |
1 |
190 |
190 |
210 |
0 |
20 |
20 |
2 |
185 |
- |
- |
- |
- |
- |
||
3 |
190 |
185 |
200 |
-5 |
10 |
15 |
||
4 |
195 |
215 |
225 |
20 |
30 |
10 |
||
5 |
170 |
- |
- |
- |
- |
- |
||
6 |
195 |
220 |
225 |
25 |
30 |
5 |
All animals were necropsied. During necropsy, no macroscopic findings were observed.AnimalNo 5 could not be necropsied because of autolysed cadaver.
Table4NecropsyResults
Sex |
Dose |
ID |
Result |
Sex |
Dose |
ID |
Result |
♀ |
2000 mg/kg |
1 |
no finding |
♀ |
2000 mg/kg |
4 |
no finding |
2 |
no finding |
5 |
autolytic changes |
||||
3 |
no finding |
6 |
no finding |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 of the test item Ethyl lactate is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
- Executive summary:
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Ethyl lactate is according to UN Globally Harmonized System of Classification, Labelling and Packaging of Chemicals classified in Category 5 with a LD50 cut off value 2500 mg/kg body weight according to Regulation (EU) Nr. 1272/2008 (CLP), after single oral administration to Wistar rats.
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