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Diss Factsheets

Toxicological information

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
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Directive 96/54/EEC
Deviations:
not specified
GLP compliance:
yes
Type of study:
not specified
Justification for non-LLNA method:
Not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
432-100-9
EC Name:
-
Molecular formula:
C78H58N15Na13O58S19
IUPAC Name:
reaction mass of: pentasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate; tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; tetrasodium 4-amino-5-hydroxy-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: unknown
- Expiration date of the lot/batch: unknown
- Purity test date: unknown
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: unknown
- Specific activity: unknown
P a g . 3 | 13
- Locations of the label: unknown
- Expiration date of radiochemical substance: unknown
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: unknown
- Stability under storage conditions: unknown
- Stability under test conditions: unknown
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium:
The vehicle is bi-distilled water. Solubility of test material in water is 506000 mg/L (at 20°C).
- Reactivity of the test substance with the solvent/vehicle /test medium (if applicable): unknown
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test material is diluted in bi-distilled water for the second intradermal injection, topical application and challenge; test material is diluted in physiological saline plus FCA for the third intradermal injection.
- Preliminary purification step (if any): unknown
- Preparation of a nanomaterial dispersion (incl. dilution): unknown
- Final dilution of a dissolved solid, stock liquid or gel: for intradermal injection and challenge, final dilution is 5% and 15% respectively; for topical application, final dilution is 50%.
- Final preparation of a solid: unknown
- FORM AS APPLIED IN THE TEST (if different from that of starting material): test material is applied as liquid form in intradermal and topical injections, while in the challenge, it is loaded on a patch.
INFORMATION ON NANOMATERIALS
- Chemical Composition: unknown
- Density: unknown
- Particle size & distribution: unknown
- Specific surface area: unknown
- Isoelectric point: unknown
- Dissolution (rate): unknown
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable): unknown
OTHER SPECIFICS
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is added: unknown
- other information: no other information

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
not specified
Details on test animals and environmental conditions:
10 animals for test group

Study design: in vivo (non-LLNA)

No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
Even if the detailed procedure of the study is not described in the analytical report of Navy MGI 1319, the details on study design reported below refer to Directive 92/69 EEC.

Induction:
1- Intradermal application: Three pairs of intradermal injections of 0.1 ml volume are given in the shoulder region which is cleared of hair.
 First injection: physiological solution plus FCA (1:1)
 Second injection: test material diluted to 5% in bi-distilled water
 Third injections: test material diluted to 5% in physiological solution plus FCA (1:1)
Injections 1 and 2 are given close to each other and nearest the head, while 3 is given towards the caudal part of the test area.
For the control animals, the second and third injections are performed with vehicle only
2- Topical application: The test area is cleared of hair. A filter paper is fully-loaded with test substance diluted to 50% in bi-distilled water and applied to the test area and held in contact by an occlusive dressing for 48 hours.


Challenge:

The flanks of animals are cleared of hair. A patch or chamber loaded with the test substance, diluted to 15% in bi-distilled water, is applied to one flank of the animals and, when relevant, a patch or chamber loaded with the vehicle only may also be applied to the other flank. The patches are held in contact by an occlusive dressing for 24 hours.
Only one challenge is performed. The evaluation of reactions is assessed at 24h and 48h after challenge

No. of animals per dose: 10 animals for test group and 5 animals for control group

Challenge controls: 10 animals for test group and 5 animals for control group


Positive control substance(s): not reported
Challenge controls:
10 animals for test group and 5 animals for control group
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
15%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Not specified
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:
10
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
15%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
15%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
15%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 15% Signs of irritation during induction: No animals showed Oedema after induction. The determination of erythema was not possible due to the blue coloration of the treated skin. No evidence of sensitization at challenge

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not a skin sensitizer
Executive summary:

An in vivo test was conducted according to the EU B.6 test method (96/54/EEC) to assess the skin sensitization potential of the test material Navy MGI 1319 (EC 432-100-9).
Test group and negative control animals were treated as follows:
- Intradermal injection of the test substance at final concentration of 5% in the vehicle for the test group and intradermal injection of the vehicle only for the control group
- Topical application of the test substance at final concentration of 50% in the vehicle
- Challenge of the test substance at final concentration of 15% in the vehicle
The concentration of test substance used for the induction exposure should be well-tolerated systemically and should be the highest to cause mild-to-moderate skin irritation, while the concentration used for the challenge exposure should be the highest non-irritant dose. The appropriate concentrations can be determined from a pilot study.
In the present study, the maximum concentration not causing irritating effects in preliminary test was 15%. During induction no animals showed signs of irritation and determination of erythema was not possible due to the blue coloration of the treated skin.
For the evaluation of challenge patch test reactions, MAGNUSSON AND KLIGMAN grading scale has been considered:
0 = no visible change
1 = discrete or patchy erythema
2 = moderate and confluent erythema
3 = intense erythema and swelling
No evidence of sensitization was seen at challenge: Navy MGI 1319 (EC 432-100-9) was not considered a skin sensitizer.