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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Sufficient information on the M&M is available to determine the reliability. The study has been performed according to OECD and/or EC guidelines. However, since the study was performed with a substance analogue and the data are read across, the Klimisch score is 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Remarks:
study performed before GLP was in place.

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium nitrate
EC Number:
229-347-8
EC Name:
Ammonium nitrate
Cas Number:
6484-52-2
Molecular formula:
H3N.HNO3
IUPAC Name:
Ammonium nitrate
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): P0018 = Ammonium nitrate
- Physical state: white crystalline solid
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ltd., The Field Station, Grimston, Aldbrough, Hull, HU11 4QE
- Weight at study initiation: 2.72-3.23 kg
- Housing: individually in grid floor cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum):free access
- Acclimation period: at least 3 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 C
- Humidity (%): 44-53%
- Air changes (per hr): single air conditioned
- Photoperiod (hrs dark / hrs light):14 hours artificial light (06.00-20.00)

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
other: each animal served as its own control
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 0.5 g moistened with water
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: covered with gauze patch and plastic collar around the neck


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towel moistened with water.
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: No erythema observed at t=1h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: No erythema observed at t=1h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: No erythema observed at t=1 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no edema observed at t=1 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no edema observed at t=1 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no edema observed at t=1 h
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
5
Reversibility:
other: not applicable
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
5
Reversibility:
other: not applicable
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
5
Reversibility:
other: not applicable

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not classified according to Regulation (EC) 1272/2008
Conclusions:
P0018 (ammonium nitrate) was regarded as non-irritant to rabbit skin.