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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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11
Version / remarks:
February 1965
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
7,16-dichloro-6,15-dihydroanthrazine-5,9,14,18-tetrone
EC Number:
204-980-2
EC Name:
7,16-dichloro-6,15-dihydroanthrazine-5,9,14,18-tetrone
Cas Number:
130-20-1
Molecular formula:
C28H12Cl2N2O4
IUPAC Name:
15,30-dichloro-2,17-diazaheptacyclo[16.12.0.0³,¹⁶.0⁴,¹³.0⁶,¹¹.0¹⁹,²⁸.0²¹,²⁶]triaconta-1(30),3,6,8,10,13,15,18,21,23,25,28-dodecaene-5,12,20,27-tetrone
Test material form:
solid: particulate/powder
Details on test material:
Vat Blue 6

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy
- Age at study initiation: 12 to 15 weeks
- Weight at study initiation (means): males: 2.58 Kg; females: 2.73 Kg
- Housing: single
- Diet ad libitum: Styles-Oxoid
- Water ad libitum: sterile filtered water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50 to 70
- Photoperiod (hrs dark / hrs light): 14/10

IN-LIFE DATES: From: To:

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Remarks:
left side shaved; right side shaved and abraded
Vehicle:
water
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL per test site
- Concentration (if solution): 1000 mg/mL

Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3 males + 3 females
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: at least 10%
- Type of wrap if used: aluminium foil secured with "Sleek" adhesive tape. The test sites were then covered by a 6" wide "Coban" self adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24 and 72 hours

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Remarks:
of 6 animals
Time point:
24 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
24 h
Score:
2.83
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Remarks:
intact and abraded skin
Basis:
mean
Time point:
other: 24 + 72 h
Score:
2.08
Max. score:
8
Remarks on result:
probability of mild irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met