Registration Dossier
Registration Dossier
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EC number: 604-012-2 | CAS number: 137296-15-2
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- 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
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- See "Details on study design"
- GLP compliance:
- 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 was used in the modified Draize prophetic patch tests.
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Route of administration:
- dermal
- Details on study design:
- Two modified Draize prophetic patch tests were conducted, each using 203 subjects, to investigate the contact sensitization potential of a 12% Ammonium Lactate lotion. In both studies, the lotion was applied to the back under occlusive patches three times per week, for a 48-h period during the week and a 72-h period over the weekends, for a total of 10 applications. After a 2-week non-treatment period, a challenge patch was applied to an untreated site for 72 h.
Results and discussion
- Results of examinations:
- No sensitisation was reported in either study.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, no sensitisation was reported in two modified Draize prophetic patch tests.
- Executive summary:
Two modified Draize prophetic patch tests were conducted, each using 203 subjects, to investigate the contact sensitization potential of a 12% Ammonium Lactate lotion. In both studies, the lotion was applied to the back under occlusive patches three times per week, for a 48-h period during the week and a 72-h period over the weekends, for a total of 10 applications. After a 2-week non-treatment period, a challenge patch was applied to an untreated site for 72 h. No semsitisation was reported in either study.
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