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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD testing guideline compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-(2,5-dimethyl-1,4-phenylene)bis[4-[(5-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide
EC Number:
279-211-7
EC Name:
N,N'-(2,5-dimethyl-1,4-phenylene)bis[4-[(5-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide
Cas Number:
79665-24-0
Molecular formula:
C44H34Cl2N6O4
IUPAC Name:
2-Naphthalenecarboxamide, N,N'-(2,5-dimethyl-1,4-phenylene)bis[4-[2-(5-chloro-2-methylphenyl)diazenyl]-3-hydroxy-
Test material form:
solid: bulk
Details on test material:
- Substance type: red material
- Physical state: solid
- Analytical purity: approx 100%
- Purity test date: no data
- Lot/batch No.: AL 56/37+38
- Expiration date of the lot/batch: December 31, 1988
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Kleintierfarm Madoerin AG, Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 14 weeks (male) - 15 weeks (females)
- Weight at study initiation: male 2.6 kg, females 2.5 - 2.9 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3 degrees centigrade
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1988-09-19 To: 1988-09-22

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: polyethyleneglycol
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4h
Observation period:
72h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 10 cm x 10 cm
- Type of wrap if used: patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped
around the abdomen and anchored with an elastic bandage.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no effects
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no effects
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no effects
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no effects
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no effects
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no effects
Remarks on result:
no indication of irritation
Other effects:
In the area of application a red staining of the treated skin by pigment or coloring of the test article was observed during the whole observation period.

No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
The body weight gain of all rabbits was similar.
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU