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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reliability adopted from OECD SIDS document - Meets generally accepted scientific standards and acceptable for assessment (original literature not available)

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
SIDS Initial Assessment Report For SIAM 17 - Ammonium Chloride (12125-02-9)
Author:
OECD SIDS
Year:
2004
Bibliographic source:
UNEP Publications
Report date:
2004
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Principles of method if other than guideline:
Federal Register, Vol. 43, No. 163, 1978
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Ammonium chloride
EC Number:
235-186-4
EC Name:
Ammonium chloride
Cas Number:
12125-02-9
IUPAC Name:
ammonium chloride
Details on test material:
- Name of test material (as cited in study report): Ammonium Chloride
- Analytical purity: Reagent grade
- Lot 50820

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Rich-Glo-farms (U.S.D.A. 74-AA-29), El Campo, Texas USA
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: Singly in galvanized steel cages placed over trays lined with aspen bedding
- Diet: Ad libitum, Purena Complete Rabbit Chow, Lot #197C and City of Houston
- Water: Ad libitum, tap water
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2- 24.4
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): No data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
- Type of application: Test substance was applied to gauze pads which had been moistened with 1 ml distilled-deionized water
- Restrainers: Yes
Duration of treatment / exposure:
24 hours
Observation period:
4 days
Number of animals:
6
Details on study design:
TEST SITE
- Application: Two site/animal were exposed to the test substance
- Area of exposure: 1 x 1 cm
- % coverage: No data
- Type of wrap if used: Polyethylene wrapper (secured with masking tape)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No (Test site was brushed clean)

SCORING SYSTEM: Skin was scored according to the method of Draize (see below)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all six animals (12 test sites)
Time point:
other: 24 hours
Score:
2.4
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all six animals (12 test sites)
Time point:
other: 48 hours
Score:
0
Max. score:
4
Reversibility:
other: no erythema was noticed
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all six animals (12 test sites)
Time point:
other: 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no erythema was noticed
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all six animals (12 test sites)
Time point:
other: 24, 48 and 72 hours
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all six animals (12 test sites)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no edema was noticed
Irritant / corrosive response data:
Unabraided skin (12 test sites): 7 test sites were scored with a draize score of 2 while 5 test sites had a draize score of 3, 24 hours after removal of the test patch. These changes were not observed after 48, 72, 96 hours. No edema or eschar was found at any observation time point.

Abraded skin was also scored. (However, these values are not included in the final assessment of skin irritation potential of the test substance).
- abraided (12 test sites; 24 hour observation time point): Erythema score of 2 at 7 sites, and an erythema score of 3 was recorded at 5 sites. These changes were not observed after 48, 72, 96 hours. No edema or eschar was found at any observation time point.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information