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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report. No purity information available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
according to Fed. Reg. 38, No. 187, § 1500.41, 1973 (Draize test)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Name of the test substance used in the study report: Scheckfarbstoff AS
The purity is stated as 100% of the drawn chemical structure in the order sheet. (Chemical structure is identical to the main component of the UVCB, CAS 6359-10-9)
The substance is stated to be a sales product.
The water solubility is indicated to be 20g/L. No information on pH is provided.
Specific details on test material used for the study:
solid
Scheckfarbstoff A.S.
Content: 100%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Mean body weight: 2.5 - 3.5 kg
The rabbits are kept in individual cages measuring 540 x 360 x 315 mm or in restraining devices which allow the back of the animal to be treated. The animal house is ventilated (renewal of air = 12 times per hour; temperature 22°C; hygrometry 55 +/- 10%). The ear of each animal is pierced and a metal tag attached for individual identification.
200 g of food is provided per animal and day in the form of granules; water is given automatically and ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
0.5 g (made into a paste immediately using 0.3 ml of water)
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6
Details on study design:
The rabbits are clipped with a fine toothed electric clipper to bare a skin surface of 14 x 14 cm; thus, a precise cut can be achieved without irritating the skin mechanically. The animals are left to rest for 24 hours and then only those with perfectly healthy skin are chosen for the study.
The right flank is scarificed with a sterile scalpel blade, making 3 parallel superficial incisions 2 cm long and 0.5 cm apart. The incisions are epidermal and do not damage the dermis (should bleeding occur, a new animal is utilized).
The treated areas are subsequently covered with a 2 cm square gauze pad consisting of sterile, hydrophilic gauze of 4 layers. The material to be tested and the gauze pads are kept in contact with the skin by a patch consisting of a central, circular disc of 22 mm diameter with a surrounding adhesive, hypoallergenic, perforated plaster 10 mm wide.
Finally, an adhesive tape 6 cm wide is wound around the animal to complete the fixing of the patches. Care is taken so that the respiratory and abdominal movements of the animal are not restricted.
The rabbits are then placed for 24 hours in restraining devices.
After 24 hours of contact with the skin, the patches are removed. 1 hour later, the primary skin irritation index is evaluated and the animals are then put back into their individual cages. 48 hours later, a 2nd reading is made to determine the extent of any recovery (the 2 readings are performed respectively 25 and 72 hours after test substance application).
If after the last reading, any irritation is noted, the animals are maintained under observation for 1 week. On the 7th day, another reading is made, special attention to be paid to the presence of desquamation at the site of application.
The scores obtained on the intact and abraded skin - for erythema and edema respectively - are added at 25 and 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 25 - 72 h
Score:
0.42
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 25 - 72 h
Score:
0.92
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 25 - 72 h
Score:
0.08
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 25 - 72 h
Score:
1.17
Max. score:
2
Reversibility:
not fully reversible within: 7 days in one animal
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
See attached figure for table.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met