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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:
12 Jan - 12 Feb 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was not valid at time of test conduct

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate
EC Number:
240-267-2
EC Name:
Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate
Cas Number:
16102-99-1
Molecular formula:
C22H18N2O11S3.2Na C22H16N2Na2O11S3
IUPAC Name:
disodium 1-amino-9,10-dioxo-4-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)amino]-9,10-dihydroanthracene-2-sulfonate
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: mean 273 g; range: 208 g to 332 g; n = 15
- Housing: group-housing (5/cage)
- Diet: ERKA-Mischfutter Nr. 8300 for guinea pigs and rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 12. Jan to 12. Feb 1988

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
2 x 0.1 mL 1% solution in physiological saline
2 x 0.1 mL 1% solution in Freund's Adjuvans
Day(s)/duration:
Day 1 of study
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
2.5%; 0.5 mL
Day(s)/duration:
on Day 9 of study for 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
2.5%; 0.5 mL
Day(s)/duration:
on Day 22 of study for 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Determination of primary not irritating concentration: 6
Determination of intradermal tolerability: 3
Sentinel group: 5
Control group: 5
Treatment group: 10
Details on study design:
RANGE FINDING TESTS:

Determination of the primary non-irritant concentration:
In a dermal-occlusive test for primary skin irritation, each of the following test concentrations was applied to the left flank of two guinea pigs:
25.0 % in isotonic saline
2.5 % in isotonic saline
0.25 % in isotonic saline
The hair on the left flanks of the animals was removed mechanically. 0.5 mL of the test substance preparation was applied to a 2 x 2 cm cellulose patch, which was then fixed to the left flank and covered occlusively for 24 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and oedema

Determination of the tolerance of intradermal injections:
To determine the tolerance of intradermal injections, each of the following preparations (5.0%, 1.0%, 0.2% in isotonic saline) was administered twice by intradermal injection to 3 guinea pigs. The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulder.


MAIN STUDY
A. INTRADERMAL INDUCTION
- No of Injections: 2 x 3 preparations: 50% FCA, 1% TS in 0.9% NaCl, 1% TS in 50% FCA - treatment group
50% FCA, 0.9% NaCl, 50% FCA - control and attending group
- Exposure period: Injection on Day 1, observation Day 1 to Day 7
- Site: shoulder

B. DERMAL INDUCTION EXPOSURE
- No. of exposures: one
- Exposure period: 48 hours
- Test groups: 2.5% TS in 0.9% NaCl
- Control group: 0.9% NaCl
- Site: shoulder
- Frequency of applications: single
- Duration: Day 9 to Day 22
- Concentrations: 2.5%

C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 22
- Exposure period: 24 hours
- Test groups: 2.5% TS + 0.9% NaCl
- Control group: 2.5% TS + 0.9% NaCl
- Site: right flank: TS; left flank: 0.9% NaCl
- Concentrations: 2.5%
- Evaluation (hr after challenge): 24 and 48 hours
Positive control substance(s):
yes
Remarks:
bi-annually tested

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
blue staining of skin, not interfering with assessment
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
blue staining of skin, not interfering with assessment
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
blue staining of skin, not interfering with assessment
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
blue staining of skin, not interfering with assessment

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not sensitizing in pirbright white guinea pigs.
Executive summary:

Testing for sensitizing properties of Reactive Blue 19:1 was performedin female Guinea pigs according to the method of MAGNUSSON &KLIGMAN. Intradermal induction was performed using 1% reactive Blue 19:1.in isotonic saline. Dermal induction and challenge treatment were carried out with 2.5% Reactive Blue 19:1 in isotonic saline.

Based on the results of this study Reactive Blue 19:1 showed no evidence for sensitizing properties.