Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: experimental study on similar substance
Adequacy of study:
key study
Study period:
March 9,1994 - May 20,1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, test procedure in accordance with OECD 406 methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was performed before the validation of LLNA OECD method and is considered to be valid and acceptable for the assessment.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Company distributed by Anlab s.r.o. Praha
- Weight at study initiation: 390-472 g
- Housing: Guinea pigs were housed in separate plastic cages type T4.
- Diet : Experimental animals were fed with a standard granulated feed mixture with a composition which provided full biological and nutritional diet for experimental animals. The mixture contains oats, barley, soy flour extracted, protein, wheat bran, sodium chloride etc.
- Water: guinea pigs were supplied with safe drinking water, according to CSN 757111 and each animal additionaly received 20 mg of ascorbic acid per day.
- Acclimation period: at least 5 days

Regular cleaning and disinfection of cages was performed to prevent contamination of pathogens according to standard operating
procedure.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° C ± 3°C
- Humidity (%): 50% ± 15%
- Photoperiod: 12-hour light cycle
Route:
intradermal and epicutaneous
Vehicle:
other: water for injections and vaseline alba for topic application
Concentration / amount:
For injections: 0,5 % of the tested substance in water solution
For topic application: 25 % for tested substance in vaseline alba

Route:
epicutaneous, occlusive
Vehicle:
other: water for injections and vaseline alba for topic application
Concentration / amount:
For injections: 0,5 % of the tested substance in water solution
For topic application: 25 % for tested substance in vaseline alba

No. of animals per dose:
Experimental group: 20 females x dose
Control group: 10 females x dose
Details on study design:
A. INDUCTION: INTRADERMAL INJECTION
Day 0- treated group:
Three paires of intradermal injections of 0,1 ml volume were applied to the shaved area:
injection 1: a 1:1 mixture Freunds Complete Adjuvant (FCA)/water
injection 2: 0,5 % of the test substance in water solution
injection 3: 0,5 % of the test substance in water solution formulated in a 1:1 mixture FCA/water
Day 0- control group:
Three paires of intradermal injections of 0,1 ml volume were applied to the shaved area.
injection 1: a 1:1 mixture FCA/water
injection 2: water for injection
injection 3: a 50 % w/v formulation of the vehicle in a 1:1 mixture (v/v) FCA/water

INDUCTION: TOPICAL APPLICATION
Day 7- treated group:
Tested area was again shaved. On the identical site of intradermal injection was applied a filter paper (2x4cm)
which was loaded with 10% of tested substance in white vaseline and held in contact by an occlusive dressing for 48 hours.
The gauze pad was kept in contact with the skin by an adhesive hypoallergenic patch under an occlusive aluminum foil sheet of 5x5 cm.

Day 7- control group:
Tested area was again shaved. White vaseline was applied to an identical area of intradermal injection on filter
paper (2x4 cm) in occlusive dressing for 48 hours. The gauze pad was kept in contact with the skin by an adhesive hypoalle
rgenic patch under an occlusive aluminum foil sheet of 5x5 cm.

B. CHALLENGE: TOPICAL APPLICATION
Day 21- treated and control group:
On the right side of the animals was applied a filter paper (2x2 cm) impregnated with 0.5% solution of the tested substan ce in water for injections, occlusive dressing covered a period of 24hrs.
After 1,24,48 and 72 hours was removed the patch and the challenge area was cleaned with water and was carried out cl inical trials, focusing on the intensity of erythema and edema.


Reading:
1st reading
Hours after challenge:
1
Group:
test group
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 1.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Edema.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
1
Group:
negative control
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 1.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
1
Group:
test group
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 1.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
1
Group:
negative control
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 1.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0,5 % of the tested substance in water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: all
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
No positive skin reaction was observed in the experiment.
Executive summary:
Skin was exposed to maximal concentration of the tested substance.
The number of sensitized animals determine the potency of contact allergens. No positive skin reaction was observed in the first or in repeated experiments and it can be concluded that the tested substance is not an allergen
There were no differences in growth and development of animals between experimental and control group. The tested substance is not an allergen.






Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A guinea pig maximisation test is available for Direct Black 19 following official guidelines of OECD 406.

The result shows no sensitising effects after 1, 24, 48 and 72 hours.

Migrated from Short description of key information:

Not sensitising

Justification for selection of skin sensitisation endpoint:

Study well documented, test procedure in accordance with OECD 406 methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Migrated from Short description of key information:

No data

Justification for classification or non-classification

No classification for sensitisation is warrented under Regulation CE 1272/2008.