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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:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
additional measurement of skin thickness with cutimeter
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study has been conducted when the LLNA was not yet the standard method.

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
EC Number:
401-560-2
EC Name:
Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
Cas Number:
108624-00-6
Molecular formula:
C28H(21-x-y)ClF2Li(x)N8Na(y)O16S5
IUPAC Name:
Lithium sodium hydrogen-4-amino-6-(5-(5-chloro-2,6-difluoropyrimidine-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
Details on test material:
Reactive Blue FC 05717

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstr. 27, 0-33178 Borchen, SPF breeding colony.
- Body weight at start of study: 291-405 g
- Age at start of study: 5-8 wk
- Housing: in macrolon cages (type 4) on soft wood granulate
- Diet: Altromin 3022 for guinea pigs, ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 8 d
- Animal identification: fur marking and cage numbering

ENVIRONMENTAL CONDITIONS
- Temperature: 21-23°C
- Humidity: 35-60%
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: August 24, 1999 To: September 24, 1999

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.5% / 0.1 mL
Day(s)/duration:
Day 1 - one injection in water and one injection in water and Freund's Adjuvant
Adequacy of induction:
other: highest possible concentration not leading to complete discolouration of animal
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10% / 0.5 mL
Day(s)/duration:
Day 8 - for 48 hours
Adequacy of induction:
highest technically applicable concentration used
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10% / 0.5 mL
Day(s)/duration:
Day 22 - for 24 hours
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10% / 0.5 mL
Day(s)/duration:
Day 36 - for 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 2 x 10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal + 1 epicutaneous
- Exposure period: intradermal: 24 hours; epicutaneous: 48 hours
- Test groups: 1
- Control group: 2
- Site: shoulder
- Frequency of applications: Day 1; Day 8
- Duration: 24 and 48 hours
- Concentrations: 0.5 and 10%

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Day 22 and Day 36
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1 + 1
- Site: flank
- Concentrations: 10%
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches

as the blue discolouration of the skin did not allow the evaluation of skin reddening, the thicknes of skin folds was measured with a cutimeter before and after challenge treatment to assess for sensitising properties
Positive control substance(s):
yes
Remarks:
formaldehyde

Results and discussion

Positive control results:
1. Challenge: 2% formaldehyde - positive effects in the treatment group and to a lesser effect in the control group
2. Challenge: 0.5% formaldehyde - positive effects in the treatment group and to a lesser effect in the control group

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% test substance
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.52 after challenge: 1.66 (test substance flank) = 0.14
Remarks on result:
other: skin fold thickness
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
10% test substance
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.52 after challenge: 1.66 (test substance flank) = 0.14
Remarks on result:
other: skin fold thickness
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.48 - after challenge: 1.59 (control flank) = 0.11
Remarks on result:
other: skin fold thickness
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.48 - after challenge: 1.59 (control flank) = 0.11
Remarks on result:
other: skin fold thickness
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% test substance
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.57 - after challenge: 1.84 (test substance flank) = 0.27
Remarks on result:
other: skin fold thickness
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10% test substance
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.57 - after challenge: 1.78 (test substance flank) = 0.21
Remarks on result:
other: skin fold thickness
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.53 - after challenge: 1.65 (control flank) = 0.12
Remarks on result:
other: skin fold thickness
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.53 - after challenge: 1.63 (control flank) = 0.10
Remarks on result:
other: skin fold thickness
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% test substance
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.46 - after challenge: 1.59 (test substance flank) = 0.13
Remarks on result:
other: skin fold thickness
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10% test substance
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.46 - after challenge: 1.62 (test substance flank) = 0.16
Remarks on result:
other: skin fold thickness
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.45 - after challenge: 1.54 (control flank) = 0.09
Remarks on result:
other: skin fold thickness
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.45 - after challenge: 1.51 (control flank) = 0.06
Remarks on result:
other: skin fold thickness
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% test substance
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.73 - after challenge: 1.84 (test substance flank) = 0.11
Remarks on result:
other: skin fold thickness
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10% test substance
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.73 - after challenge: 1.97 (test substance flank) = 0.24
Remarks on result:
other: skin fold thickness
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.67 - after challenge: 1.69 (control flank) = 0.02
Remarks on result:
other: skin fold thickness
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.67 - after challenge: 1.74 (control flank) = 0.07
Remarks on result:
other: skin fold thickness
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.5%
No. with + reactions:
15
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
0.5%
No. with + reactions:
11
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Remarks:
there might be skin sensitising properties based on skin fold thickness measurements
Conclusions:
The test substance might have sensitizing properties based on skin fold thickness measurements.
Executive summary:

A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406, in compliance with GLP. Concentrations of the test substance at 5 and 25% in deionized water were selected for the intradermal and dermal inductions. The test substance is a blue dye that strongly colours the skin, making it impossible to evaluate skin irritation reactions such as reddening. Therefore, effects were measured as thickness of a skin fold using a cutimeter. At the first reading (concentration: 10%), differences in skin fold thickness were seen in the treated groups between the treated and control flanks. The difference was notable at 48 h and slightly attenuated at 72 h. These effects between substance and sham-treated sides were less pronounced in the control animals. The second reading (concentration: 10%) yielded similar results. However, the increases in skin fold thickness was less distinctive after 48 h, but was more pronounced at 72 h in the treated group. Under the study conditions, the test substance might have sensitizing properties (Heiman, 1986).