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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:
1974
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:
1974
Report date:
1974

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
Remarks:
Study performed before GLP principles were in place.

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate
EC Number:
229-142-3
EC Name:
Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate
Cas Number:
6417-83-0
Molecular formula:
C21H12N2O6S.Ca
IUPAC Name:
calcium 3-hydroxy-4-[(1-sulfonato-2-naphthyl)diazenyl]-2-naphthoate
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: bred on the premises
- Age at study initiation: 3-4 months
- Weight at study initiation: male 2.54 kg and female 2.46 kg
- Housing: single
- Diet: a commercial irradiated diet (Styles-Oxoid) ad libitum
- Water: sterile filtered water was available at al times
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 10 hours artificial light (08.00-18.00h)

Test system

Type of coverage:
occlusive
Preparation of test site:
other: left shaved; right shaved+abraded
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Amount applied: 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2 test sites of 2.5 cm2
- % coverage: 10%
- Type of wrap if used: Gauze pad covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban"-self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

REMOVAL OF TEST SUBSTANCE
- Washing: No
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
ca. 1.17
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact and abraded skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of an in vivo test, in which 6 New Zealand White rabbits (3 male, 3 female) were occlusively exposed to 0.5 g of the test substance in 0.5 mL water for 24 hours, it is concluded that the test substance is not corrosive and not irritant to the skin.
Executive summary:

In a skin irritation test, 6 New Zealand White rabbits (3 male, 3 female) were exposed to 0.5 g of the test substance in 0.5 mL water. Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded. The application site was covered with aluminium foil secured with adhesive tape. The test sites were then enclosed by a self adhesive bandage the edges of which were fixed to the skin. After 24 hours, the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours. Mild to moderate oedema was seen at the test sites in 3/6 rabbits 24 hours after application of the test compound. There was no difference between intact and abraded sites. This reaction had subsided by 72 hours. The primary irritation score was 0.6. The substance is not considered to be corrosive and/or irritating to rabbit skin.