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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:
8.3.-22.4.1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
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 in year 1994.

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
EC Number:
277-616-3
EC Name:
Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
Cas Number:
73816-74-7
Molecular formula:
C28H24ClN7O10S3.3Na
IUPAC Name:
trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
impurity 1
Chemical structure
Reference substance name:
Sodium chloride
EC Number:
231-598-3
EC Name:
Sodium chloride
Cas Number:
7647-14-5
Molecular formula:
ClNa
IUPAC Name:
sodium chloride
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Reactive Red 45:1
- Physical state: red solid powder
- Analytical purity: 85% (w/w)
- Impurities (identity and concentrations): NaCl (CAS: 7647-14-5) 15% (w/w)
- Lot/batch No.: 7010
- Expiration date of the lot/batch: unlisted
- Storage condition of test material: The test substance should be stored in dry room in dark in closed container at the room temperature.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Anlab s.r.o., Praha
- animals: healthy young adult males, nulliparous, non-pregnant
- Weight at study initiation: 300g-336g
- Housing: plastic cages, 5 animals in each cage
- Diet: ad libitum,
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C permanently monitored huminidy
- Humidity (%): 50%±15% permanently monitored huminidy
- Photoperiod: 12 light/12 dark, fluorescent lighting

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: aqua pro injection, vaselinum alba
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: aqua pro injection, vaselinum alba
No. of animals per dose:
No.of animals per sex per dose: 10 control + 20 exposed animals
Details on study design:
Exposed group
- day 0 - intradermal injections : injections 2 x 0.1 mL in the shoulder region, 20 exposed animals
1 – a 1:1 mixture (v/v) Freunds Complete Adjuvant FCA/aqua pro iniectione
2 - 1% solution of test sample in aqua pro iniectione
3 - 1% solution of test sample in injection 1 (1:1)

Control group
1 – a 1:1 mixture (v/v) Freunds Complete Adjuvant FCA/aqua pro iniectione
2 - aqua pro iniectione
3 - aqua pro inietione in injection 1 (1:1)

– day 7 - topical application
– exposed group - 25% sample in vaselinum alba on filter paper – applied to the test area and held in contact by an occlusive dressing (for 48 hours)
-control group – filter paper with vaselinum alba

- with occluded patch (sample in vaseline)


Challenge controls:
Challenge: day 20 – control and exposed group
-concertation: 1% test substance in aqua pro injectione
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
1% test substance
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no pathological reaction of skin
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1% test substance
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no pathological reaction of skin
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
1% test substance
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no pathological reaction of skin
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
1% test substance
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no pathological reaction of skin
Remarks on result:
no indication of skin sensitisation
Reading:
other: not included
Group:
positive control
Dose level:
not included
Remarks on result:
other: Not included

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Non-sensitizer in all animals no erythema and no oedema were recorded
Executive summary:

The test substance Reactive Red 45:1 was tested for the assessment of skin allergic effects using albino guinea pigs.

The method is analogous to the OECD Test Guideline No. 406, Skin sensitisation.

The Magnusson and Kligman maximization procedure was followed.

The main test was performed on 20 treated and 10 control animals.

The experiment proceeded in three phases: two induction phases - topical application and the challenge phase. Potential skin reactions were evaluated at the end of experiment.

The evaluation of skin reactions in the exposed group carried out at 48 and 72 hours after the start of the challenge phase of study did not show any changes in skin of animals in both flanks.

No allergic skin reactions were observed incontrol group 48 hours and at 72 hoursfrom the start of application of the challenge dose.

No other negative clinical symptoms through the experiment were recorded.

The test substance Reactive Red 45:1, was not shown to be a contact allergen in guinea pigs.

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