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Administrative data

Description of key information

Based on reliable skin and eye irritation studies with ammonium nitrate, the substance appears to be not irritating to skin, but irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
comparable to guideline study with acceptable restrictions
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.
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)
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
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
5
Interpretation of results:
GHS criteria not met
Conclusions:
P0018 (ammonium nitrate) was regarded as non-irritant to rabbit skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Duration of treatment / exposure:
24 hr / 100 mg
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 4 days
Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Classified as Category 2 according to Regulation (EC) No 1272/2008
Conclusions:
Based on the effects seen on the conjuctiva in all three animals tested (redness score: average 1, 2 and 3 days) the substance should be considered as being irritating to the eye (Category 2A).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a reliable skin irritation study in rabbits (performed similar to OECD 404) with ammonium nitrate, no signs of skin irritation were observed up to 72 hours. However, in an eye irritation study in rabbits (similar to OECD 405) with ammonium nitrate, clear irritation was observed with conjunctivae having scores above 2. However the effects were fully reversible within 7 -10 days. Irritation to the iris and cornea was limited (average scores 0.3), however the chemosis score had an average of 1. In a validation study the in vitro slug mucosal irritation assay was used to study ammonium nitrate.

Justification for classification or non-classification

Ammonium nitrate does not have to be classified for skin irritation according to Regulation (EC) No 1272/2008. However, for eye irritation the substance does have to be classified. According to the CLP Regulation as Eye irritant Cat 2, H319 causes serious eye irritation.

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