Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Reliability adopted from OECD SIDS document - Meets generally accepted scientific standards and acceptable for assessmnet (original literature not available)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
SIDS Initial Assessment Report For SIAM 17 - Ammonium Chloride (12125-02-9)
Author:
OECD SIDS
Year:
2004
Bibliographic source:
OECD - submitted on Janaury 30th 2004
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Register, vol.43, no 163
Version / remarks:
1978-08-22
Deviations:
not specified
GLP compliance:
yes

Test material

1
Chemical structure
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
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot No.of test material: 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
- Housing: Individually in galvanized steel cages placed over trays.
- 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

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 applied: 0.5 g
- Type of application: the test substance was applied to gauze pads which had been moistened with 1 mL distilled-deionized water
- Restrainers: Yes
Duration of treatment / exposure:
24 hour(s)
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
- Type of wrap if used: a polyethylene wrapper (secured with masking tape)

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

SCORING SYSTEM: The skin was scored according to the method of Draize (see below).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Worst case scenario based on the results reported.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Worst case scenario based on the results reported.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Worst case scenario based on the results reported.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Worst case scenario based on the results reported.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Worst case scenario based on the results reported.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Worst case scenario based on the results reported.
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all six animals (12 test sites)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Unabraded 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. (These values however are not included in the final assessment of skin irritation potential of the test substance).
- abraded (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:
GHS criteria not met