Propanoic acid, 2-hydroxy-, ammonium salt (1:1), (2S)-

Repeated dose toxicity: dermal

Administrative data

Endpoint:

sub-chronic toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Review publication

Data source

Reference

Reference 1

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:

1998

Bibliographic source:

International Journal of Toxicology 17 (Suppl. 1)

Reference 2

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:

1988

Bibliographic source:

Washington, DC: FDA

Materials and methods

Principles of method if other than guideline:

See "Details on study design"

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

52003-58-4

Test material form:

solid: crystalline

Specific details on test material used for the study:

A 12% Ammonium lactate lotion, pH 5.0-5.5, was used in this study

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male/female

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

1 other: mL/kg bw/day

Remarks:

of a 12% ammonium lactate lotion

Doses / concentrations 2

Dose / conc.:

4 other: mL/kg bw/day

Remarks:

of a 12% ammonium lactate lotion

No. of animals per sex per dose:

See "Details on study design"

Control animals:

yes

Details on study design:

In a 90-day dermal study, 1 mL/kg bw/day of a 12 % ammonium lactate lotion, pH 5.0-5.5, was applied to the backs of six rabbits, three per sex, and 4 mL/kg bw/day were applied to the backs of eight rabbits, four per sex. Saline was applied to the backs of a control group of 10 rabbits, five per sex. Use of restraints was not specified. The backs of half of the animals were abraded.

Positive control:

No

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Remarks on result:

other: no adverse systemic effects observed

Target system / organ toxicity

Critical effects observed:

no

Any other information on results incl. tables

Three control, one low-dose, and two high-dose animals, which died on study due to acute pneumonia and/or mucoid enteritis, were replaced. Feed consumption, body weights, haematology, clinical chemistry, and urinalysis were normal for all test groups. Absolute kidney weights of the low-dose group were significantly increased compared to controls, while the relative kidney weights were comparable. Both dose groups had mild irritation, described as a minimal to slight acanthosis, inflammatory cellular infiltration, and hyperkeratosis. Three of the high-dose animals developed minimal focal ulceration of the application areas.

Applicant's summary and conclusion

Conclusions:

In a 90-day dermal study, 1 mL/kg bw/d of a 12% ammonium lactate lotion, pH 5.0-5.5, was applied to the backs of six rabbits, three per sex, and 4 mL/kg bw/d were applied to the backs of eight rabbits, four per sex. Saline was applied to the backs of a control group of 10 rabbits, five per sex. Use of restraints was not specified. The backs of half of the animals were abraded.
Three control, one low-dose, and two high-dose animals, which died on study due to acute pneumonia and/or mucoid enteritis, were replaced. Feed consumption, body weights, haematology, clinical chemistry, and urinalysis were normal for all test groups. Absolute kidney weights of the low-dose group were significantly increased compared to controls, while the relative kidney weights were comparable. Both dose groups had mild irritation, described as a minimal to slight acanthosis, inflammatory cellular infiltration, and hyperkeratosis. Three of the high-dose animals developed minimal focal ulceration of the application areas.

Executive summary:

In a 90-day dermal study, 1 mL/kg bw/d of a 12 % ammonium lactate lotion, pH 5.0–5.5, was applied to the backs of six rabbits, three per sex, and 4 mL/kg bw/d were applied to the backs of eight rabbits, four per sex. Saline was applied to the backs of a control group of 10 rabbits, five per sex. Use of restraints was not specified. The backs of half of the animals were abraded.

Three control, one low-dose, and two high-dose animals, which died on study due to acute pneumonia and/or mucoid enteritis, were replaced. Feed consumption, body weights, haematology, clinical chemistry, and urinalysis were normal for all test groups. Absolute kidney weights of the low-dose group were significantly increased compared to controls, while the relative kidney weights were comparable. Both dose groups had mild irritation, described as a minimal to slight acanthosis, inflammatory cellular infiltration, and hyperkeratosis. Three of the high-dose animals developed minimal focal ulceration of the application areas.

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