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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
an in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Induced hypersensitive response of experimental animals to allergen challenge. Skin sensitization is immune skin reactions in guinea pigs is reflected blood flow, swelling.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A LLNA study has not been conducted because adequate data from guinea pig Maximisation test study are already available.

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 7-[[2-[(aminocarbonyl)amino]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]phenyl]azo]naphthalene-1,3,6-trisulphonate
EC Number:
279-408-8
EC Name:
Tetrasodium 7-[[2-[(aminocarbonyl)amino]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]phenyl]azo]naphthalene-1,3,6-trisulphonate
Cas Number:
80157-00-2
Molecular formula:
C28H20ClN9Na4O16S5
IUPAC Name:
tetrasodium 7-[[2-[(aminocarbonyl)amino]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]phenyl]azo]naphthalene-1,3,6-trisulphonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

In vivo test system

Test animals

Species:
guinea pig
Sex:
female
Details on test animals and environmental conditions:
- Numbero of animals: 20
- Non pregnant
- Weight: 250-350 g
- Diet: KO 16 ad libitum
- Water: drinking water with ascorbic acid
- Cage: T5 (supplied by Velaz)

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
Intradermal:
0,1 mL at 25 %;
0,1 mL at 5 % of dye
0,1 mL at 5% of dye and adjuvant (1:1)
Epicutaneous: 25 % of dye in vaseline
Challenge
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
Intradermal:
0.1 mL at 25 %
0.1 mL at 5 % of dye
0.1 mL at 5 % of dye and adjuvant (1:1)
Epicutaneous: 25 % of dye in vaseline
No. of animals per dose:
2
Details on study design:
- Route of application: injection and patch application
- Exposure period: 72 hours
- Post-exposure period of observation: 14 days
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
1
Group:
test chemical
Dose level:
0,1
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
weak swelling; edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 1.0. Group: test group. Dose level: 0,1. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: weak swelling; edema.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0,1
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
weak swelling; edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,1. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: weak swelling; edema.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0,1
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
weak swelling; edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,1. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: weak swelling; edema.
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
other: not reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Non sensitising
Executive summary:

Method

To assess the allergenic potential the test substance has been tested in albino guinea pigs, according to the OECD guideline 406.

Results

Positive reaction was found on 3 animals of the total 20 (15 % corresponding to an intradermal induction dose of 5 %).

Conclusion

Non sensitising.