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EC number: 240-267-2 | CAS number: 16102-99-1
Skin sensitisation
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:
- 1 988
- 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
- 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-(sulfooxy)ethanesulfonyl]phenyl}amino)-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
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.
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