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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study following official guidelines, GLP compliant, performed on a mixture containing the test substance and one analogue substance as pure sodium salts

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA not available as test method at the time of testing

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)
EC Number:
274-487-5
EC Name:
Disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)
Cas Number:
70236-55-4
Molecular formula:
C36H18CrN7O13S . 2 Na
IUPAC Name:
disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)
Constituent 2
Chemical structure
Reference substance name:
Disodium [3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)][N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthyl]acetamidato(2-)]chromate(2-)
EC Number:
274-488-0
EC Name:
Disodium [3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)][N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthyl]acetamidato(2-)]chromate(2-)
Cas Number:
70236-56-5
Molecular formula:
C38H22CrN7Na2O12S
IUPAC Name:
disodium [3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)][N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthyl]acetamidato(2-)]chromate(2-)
Constituent 3
Chemical structure
Reference substance name:
Disodium [3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
EC Number:
274-489-6
EC Name:
Disodium [3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
Cas Number:
70236-57-6
Molecular formula:
C36H19CrN6Na2O11S
IUPAC Name:
disodium [3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
Test material form:
solid: particulate/powder
Details on test material:
Storage conditions: room temperature
Test article received: March 4, 1993
Expiration date: February 1998
Stability in vehicle: at least 24h in water, saline, PEG400 and CMC

In vivo test system

Test animals

Species:
guinea pig
Sex:
male/female
Details on test animals and environmental conditions:
The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, initially weighing between 330 to 390 g. The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags, kept at a constant room temperature of 22+/- 3°C, at a relative humidity of 30 to 70% and a 12 hours light cycle day.The animals received ad libitum standard guinea pig pellets -NAFAG No. 845, Gossau SG and fresh water. All batches of the diet are assayed for nutritive ingredients and contamination level by the manufacturer. Analytical results are available at the animal supply office. The drinking water quality fulfilled the critical parameters in the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972). The results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschutz) are available to CIBA-GEIGY Limited, as well as the results of inhouse chemical analysis by the analytical laboratories of the Pharmaceutical Division, CIBA-GEIGY Limited.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5%
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
0.4 g of a 50% test item concentration
Day(s)/duration:
48 h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
30% of the test item in vaseline applied on the flank (on a patch 2x2 cm, ca. 0.2g paste per patch)
or only vaseline
Day(s)/duration:
24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group
Details on study design:
The induction stage was performed in 2 weeks (first week intradermal, second week epicutaneous). During weeks 3 and 4 no treatments were performed. At week 5 the challenge exposure was performed.Induction reactions. After the intradermal and the epidermal induction application irritant reactions are normally induced by the adjuvant and the high test article concentration. Because most of the reactions are treatment related and not compound related, the reactions are only described in special cases in the section of results. Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale.
The body weight was recorded at start and end of the test.
Challenge controls:
A control group of 10 animals (5 m/5 f) was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals.
Positive control substance(s):
yes
Remarks:
potassium dichromate

Results and discussion

Positive control results:
90% of animals at 24 and 48h

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10

Any other information on results incl. tables

No erythema nor oedema were recorded for the test group animals.

No test item related effect on the body weight of the animals was observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was tested for skin sensitisation following OECD 406. Under the experimental conditions the test item does not show skin sensitising properties.
Executive summary:

The test item was tested for skin sensitisation following OECD 406. Guine pigs (10 males and 10 females) were tested with intradermal and epicutaneous occlusive induction at 5% and 50% of the test item (with adjuvant for the intradermal test, vaseline for the epicutaneous), respectively, in the first two weeks. At week 5 the challenge step was performed with an occlusive patch at 30% of the test item in vaseline. Skin irritation was recorded, together with animals weight.

Under the experimental condition positive skin reactions were noted in 5% of the animals at 24h after patch removal and in 10% of the animals at 48h showed positive reactions. The test item has therefore no skin sensitising properties.