Registration Dossier
Registration Dossier
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EC number: 201-196-2 | CAS number: 79-33-4
Storage stability and reactivity towards container material
Administrative data
Link to relevant study record(s)
- Endpoint:
- storage stability and reactivity towards container material
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Principles of method if other than guideline:
- Sample was stored at 25 °C, 60% relative humitidy, for up to 60 months. Colour, lactic acid concentration, and level of heavy metals, iron, chloride, sulfate and calcium were monitored during this time.
- GLP compliance:
- not specified
- Type of method:
- ambient testing
- Specific details on test material used for the study:
- Test was performed with an 80 % aqueous solution of L-lactic acid.
- Results:
- Lactic acid solutions stored at ambient temperature in polyethylene containers are stable for at least 5 years, with no change in concentration.
- Transformation products:
- no
- Storage stability / reactivity towards container material:
- other: no reactivity towards container material.
- Conclusions:
- L-lactic acid in polyethylene containers is stable for at least 5 years when stored at ambient conditions. There is no risk for reactivity of lactic acid towards the container material.
- Executive summary:
L-lactic acid was exposed to "stressed" conditions, to investigate their effects on the stability of the acid, with regard to the formation of degradation products. When summarizing the results of the stress-testing experiments we can conclude that L-lactic acid is a stable product under most conditions tested. Only when exposed to hydrogen peroxide some oxidation occurs to acetaldehyde, pyruvic acid, acetic acid, formic acid and COX. Furthermore it is known from literature that lactic acid can decompose to acetaldehyde, formic acid and / or carbon monoxide on reaction with an excess of concentrated sulfuric acid (at room temperature) or with an excess of diluted sulfuric acid at 130 °C.
Reference
Description of key information
The stability data demonstrated that L-lactic acid is very high at ambient conditions of 25 °C. A stability period of at least 5 years is justified.
Additional information
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