Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
review article or handbook
Title:
RTECS Number- YR8500000
Year:
2012
Bibliographic source:
RTECS (Registry of Toxic Effects of Chemical Substances):- 85JCAE "Prehled Prumyslove Toxikologie; Organicke Latky," Marhold, J., Prague, Czechoslovakia, Avicenum, 1986 Volume(issue)/page/year:962,1986; Marhold, J.

Materials and methods

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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material : (3-aminophenyl)uronium chloride

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
not specified
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24H
Details on study design:
Standard Draize test

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks on result:
other: Dose : 100 mg/24H; Irritating to eyes

Applicant's summary and conclusion

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.