Registration Dossier
Registration Dossier
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EC number: 239-570-2 | CAS number: 15529-67-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Part of research on methods to improve LLNA.
Lactic acid assessed (note lactic acid canbe used as a negative control in some methods)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- As well as the standard method of using radioactivity to assess activity of the local lymph nodes, the research included asessment of cell counts in the lymph nodes
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Lactic acid
- EC Number:
- 200-018-0
- EC Name:
- Lactic acid
- Cas Number:
- 50-21-5
- Molecular formula:
- C3H6O3
- IUPAC Name:
- 2-Hydroxypropanoic acid
Constituent 1
- Specific details on test material used for the study:
- Work performed with lactic acid.
Lactic acid and lactates dissolve to form lactate ions and the acid is considered to be a suitable surrogate for assessment of the salt.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Temperature 20–24 °C and a relative humidity of 30–70%, with a 12 h light–dark cycle
Tap water and food were given ad libitum.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 5.0, 10, 25 %
- No. of animals per dose:
- Three
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Positive
In vivo (LLNA)
Results
- Key result
- Parameter:
- EC3
- Value:
- 0
- Remarks on result:
- not determinable
- Remarks:
- No indication of positive effects
Any other information on results incl. tables
Lactic acid led to local skin irritation in the high and mid dose groups.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Lactic acid proved negative by both methods used for evaluation.
Substances known to be positive sensitisers gave positive responses as expected demonstrating validity of the work.
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