Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Fed. Reg. (17 Sept 1964, § 191.11) = Draize test
Deviations:
not applicable
Remarks:
test method not reported in detail
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
EC Number:
226-106-9
EC Name:
N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
Cas Number:
5280-78-4
Molecular formula:
C40H23Cl5N6O4
IUPAC Name:
N,N'-(2-chloro-1,4-phenylene)bis{4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-2-naphthamide}
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: powder
- Analytical purity: no data
Specific details on test material used for the study:
- Physical state: powder
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: polyethylene glycol
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
mixed with the powdered material to a paste
Duration of treatment / exposure:
24 hrs
Observation period:
72 h
Number of animals:
6
Details on study design:
SCORING SYSTEM: OECD Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.16
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: slight erythema (score 1) was observed in 2 animals only at the 72 hr reading
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.08
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: slight edema (score 1) was observed in 1 animal only at the 72 hr reading

Applicant's summary and conclusion