chloride, carbonate and bicarbonate salts of ammonium and sodium

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well described acceptable study done according to GLP principles., no substance purity mentioned.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Register, vol.43, no 163-Tuesday, Aug.22, 1978

Deviations:

not specified

Principles of method if other than guideline:

Method of Draize

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium chloride

EC Number:

235-186-4

EC Name:

Ammonium chloride

Cas Number:

12125-02-9

Molecular formula:

ClH4N

IUPAC Name:

ammonium chloride

Details on test material:

Ammonium chloride, Reagent Chemical, Lot #50820
crystalline

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Six New Zealand White Albino Rabbits were randomly selected from a shipment of 12 rabbits received  on September 16, 1985 from Rich-Glo-farms (U.S.D.A. 74-AA-29), El Campo, Texas. The animals were good health, being observed for 21 days prior to testing.
The animals were housed in galvanized steel cages placed over trays lined with aspen bedding. Purena Complete Rabbit Chow, Lot #197C and City of Houston Tap Water was available at all tomes. The rabbit quarters are air conditioned, temperature ranged from 72 - 76 dgree F, relative humidity from 40 to 60 %.

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

other: about 1 mL of distilled-deionized water

Controls:

not required

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

24 hour(s)

Observation period:

at least 48 h

Number of animals:

6

Details on study design:

The backs of 6 rabbits were clipped free of hair in an area of about 15 X 12 square cm. The backs of the animals were divided into quadrants. The animals were abraided in a 2 square mm cross-hatch pattern on the tatoo side by drawing a lancet across the skin, being careful not to penetrate the dermis.  Two-one square inch areas on each rabbit were tested. Two unabraided additional 1 squre inch sites on each rabbit were also tested. 0.5 gram of crystalline Ammonium chloride were placed in a double layered 1 square inch gauze pad and affixed to the four test sites on each animal with adhesive tape. The gauze was moistened with about 1 mL of distilled-deionized water and a polyethylene wrapper was placed over the bandages and wound around the trunk. The wrapper was secured with masking tape. The animals were placed in a restraining box and replaced in their individual cages. Water was available to the animals during the test. After 24 hours the animals were released from their restraints and the bandages were removed. All bandages  were stuck to the skin by the test materials but peeled away with no skin removed. The remaining test materials was brushed of  the skin but was not other wise removed.  The skin was scored according to the method of Draize.

Results and discussion

In vivo

Results

Irritation parameter:

other: Redness/Edema/Eschar

Basis:

animal: all

Time point:

other: 48

Score:

0

Max. score:

3

Reversibility:

other: all observed effects were reversible within 48 hours

Remarks on result:

other: see below

Irritant / corrosive response data:

Redness / Edema / Eschar
Abraided( 12 tests): Score (2)X7, (3)X5  /0 /0
Unabraided (12 tests):Score (2)X7, (3)X5  /0 /0 after 24 hours
These changes were not observed after 48, 72, 96 hours

Other effects:

The only redness was observed after 24 hours and disappeared within 48 hours.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

Ammonium chloride is moderately irritant to abraided and unabraided skin.