Registration Dossier
Registration Dossier
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EC number: 604-012-2 | CAS number: 137296-15-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Review publication
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Final report on the safety assessment of glycolic acid, ammonium, calcium, potassium, and sodium glycolates, methyl, ethyl, propyl, and butyl glycolates, and lactic acid, ammonium, calcium, potassium, sodium, and TEA-lactates, methyl, ethyl, isopropyl, …
- Author:
- Andersen, F.A.
- Year:
- 1 998
- Bibliographic source:
- International Journal of Toxicology 17 (Suppl. 1)
- Reference Type:
- other: FDA review
- Title:
- FDA summary action review of the new drug application submitted by Bristol-Myers on Lac-Hydrin (Ammonium lactate) 12% lotion
- Author:
- FDA
- Year:
- 1 988
- Bibliographic source:
- Washington, DC: FDA
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- See "details on study design"
- GLP compliance:
- not specified
- Type of study:
- not specified
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 52003-58-4
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- A 12 % Ammonium lactate lotion, pH 5.0-5.5 was used in this study
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Results and discussion
- Positive control results:
- Not specified
In vivo (non-LLNA)
Results
- Reading:
- other: see Remarks on result
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- One animal was found dead on day 18 (reason not stated). No erythema was observed after induction or challenge applications, and 12 % Ammonium Lactate lotion was not a sensitiSer using guinea pigs.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, in a dermal skin sensitisation study with guinea pigs a 12% ammonium lactate lotion was not skin sensitising.
- Executive summary:
In a dermal skin sensitisation study 10 guinea pigs were treated with a 12% ammonium lactate lotion under occlusive conditions. One animal was found dead on day 18. No erythema was observed after induction or challenge applications. Based on the results, it can be stated that the test item is not a skin sensitiser.
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