Registration Dossier

Administrative data

Description of key information

AITC is calssified as Skin Corr. 1C, H314.

As the substance is classified as skin corrosive, an eye irritation study was not performed.

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
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
other: New Zealand albino
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
not specified
Controls:
no
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
other: animal euthanized for human reasons after 24h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
other: animal euthanized for human reasons after 24h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
8
Reversibility:
not reversible
Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
A primary skin irritation test was conducted with one rabbit to determine the potential for IR9804 to produce irritation after a single topical application. Under the conditions of this study, IR9804 is classified as corrosive to the skin.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to Regulation (EC) n. 1272/2008, AITC is calssified as Skin Corr. 1C, H314.