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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-04-13 to 2004-04-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002-04-24
Deviations:
yes
Remarks:
, occlusive dressing (not considered to influence the results of the study)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium hydrogensulphite
EC Number:
233-469-7
EC Name:
Ammonium hydrogensulphite
Cas Number:
10192-30-0
Molecular formula:
NH5SO3
IUPAC Name:
ammonium hydrogensulfite
Test material form:
other: solution
Details on test material:
- Name of test material (as cited in study report): ammonium bisulfite solution 70%
- Physical state: clear solution

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS - albino rabbits
- Source: Allevamento "Conelli" - Arona (NO)
- Weight at study initiation: 2820 - 2950 g
- Housing: individual housing in cages (NORYL; polyphenylenoxid; 48.2 cm x 63 cm x 37 cm)
- Diet: standard pellets (Harlan Italy)
- Water (ad libitum): cleaned water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
60 minutes as well as 24, 48, and 72 hours after application
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: 24 hours before the test item application the backs and the hips of the rabbits were shaved (area: 240 cm²). The test item was applied onto a gauze patch (2.5 cm x 2.5 cm), which was placed onto the shaved skin and secured with a plaster.

REMOVAL OF TEST SUBSTANCE
- Washing: after exposure the bandage and plaster were removed. The test substance was removed from the skin with physiological solution.

SCORING SYSTEM: according to the Draize scale

OBSERVATIONS:
- clinical signs were observed daily

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
None of the rabbits showed any signs of skin irritation or oedema.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Ammonium bisulfite solution 70% is not irritating to the skin of the rabbits.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item should not be classified as irritating to the skin.