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Administrative data

Description of key information

Skin Irritation
The primary irritation index on rabbit for (3-aminophenyl)uronium chloride is estimated to be 1.91. Based on this value, it can be estimated that(3-aminophenyl)uronium chloride exhibits slight irritation potential to rabbit skin. However, the PDII score is not considered high enough for classification of the chemical as a skin irritant. Thus, the chemical (3-aminophenyl)uronium chloride is not considered to be a skin irritant.
Eye Irritation
(3-aminophenyl)uronium chloride is irritating to rabbit eye at 100 mg/24H concentration.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
(Q)SAR
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: OECD Guideline 404 (Acute dermal irritation / corrosion)
Principles of method if other than guideline:
Prediction is done using QSAR Toolbox version 3.1
GLP compliance:
no
Test material information:
Composition 1
Species:
rabbit
Strain:
not specified
Type of coverage:
other: occlusive
Preparation of test site:
not specified
Vehicle:
not specified
Irritation parameter:
other: Primary irritation index(PII)
Basis:
mean
Score:
1.91
Reversibility:
no data
Remarks on result:
other: The PDII score indicates the chemical to be a slight skin irritant





The prediction was based on dataset comprised from the following descriptors: "Primary Irritation Index"
Estimation method: Takes average value from the 6 nearest neighbours
Domain  logical expression:Result: In Domain

(("a" and "b" )  and ("c" and "d" )  )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Aromatic amines by Skin irritation/corrosion Inclusion rules by BfR

Domain logical expression index: "b"

Similarity boundary:Target: c1(N)cc(N{+}(.Cl{-})=C(N)O)ccc1
Threshold=30%,
Dice(Atom centered fragments)

Domain logical expression index: "c"

Parametric boundary:The target chemical should have a value of logP Multicase which is >= -2.69

Domain logical expression index: "d"

Parametric boundary:The target chemical should have a value of logP Multicase which is <= 2.53

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The primary irritation index on rabbit for (3-aminophenyl)uronium chloride is estimated to be 1.91. Based on this value, it can be estimated that(3-aminophenyl)uronium chloride exhibits slight irritation potential to rabbit skin. However, the PDII score is not considered high enough for classification of the chemical as a skin irritant. Thus, the chemical (3-aminophenyl)uronium chloride is not considered to be a skin irritant.
Executive summary:

The primary irritation index on rabbit for (3-aminophenyl)uronium chloride is estimated to be 1.91. Based on this value, it can be estimated that(3-aminophenyl)uronium chloride exhibits slight irritation potential to rabbit skin. However, the PDII score is not considered high enough for classification of the chemical as a skin irritant. Thus, the chemical (3-aminophenyl)uronium chloride is not considered to be a skin irritant.

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:
4 (not assignable)
Reference:
Composition 0
Principles of method if other than guideline:
The Draize Test is an acute toxicity test devised in 1944 by Food and Drug Administration (FDA) toxicologists John H. Draize and Jacob M. Spines. Initially used for testing cosmetics, the procedure involves applying 0.5mL or 0.5g of a test substance to the eye or skin of a restrained, conscious animal, and then leaving it for set amount of time before rinsing it out and recording its effects. The animals are observed for up to 14 days for signs of erythema and edema in the skin test, and redness, swelling, discharge, ulceration, hemorrhaging, cloudiness, or blindness in the tested eye. The test subject is commonly an albino rabbit, though other species are used too, including dogs. The animals are euthanized after testing if the test renders irreversible damage to the eye or skin. Animals may be re-used for testing purposes if the product tested causes no permanent damage. Animals are typically reused after a "wash out" period during which all traces of the tested product are allowed to disperse from the test site.
GLP compliance:
no
Test material information:
Composition 1
Species:
rabbit
Strain:
not specified
Vehicle:
not specified
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24H
Details on study design:
Standard Draize test
Irritation parameter:
overall irritation score
Basis:
mean
Remarks on result:
other: Dose : 100 mg/24H; Irritating to eyes
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
(3-aminophenyl)uronium chloride is irritating to rabbit eye at 100 mg/24H concentration.
Executive summary:

(3-aminophenyl)uronium chloride is irritating to rabbit eye at 100 mg/24H concentration.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin Irritation

The primary irritation index on rabbit for (3-aminophenyl)uronium chloride is estimated to be 1.91. Based on this value, it can be estimated that(3-aminophenyl)uronium chloride exhibits slight irritation potential to rabbit skin. However, the PDII score is not considered high enough for classification of the chemical as a skin irritant. Thus, the chemical (3-aminophenyl)uronium chloride is not considered to be a skin irritant.

Eye Irritation

(3-aminophenyl)uronium chloride is irritating to rabbit eye at 100 mg/24H concentration.


Justification for selection of skin irritation / corrosion endpoint:
Model considered reliable by OECD

Justification for selection of eye irritation endpoint:
Model considered reliable by OECD

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based upon the available data, (3-aminophenyl)uronium chloride is classified as a eye irritant and not a skin irritant.