Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
other: Annex V, Part B of Council Directive 79/831/EEC
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)
EC Number:
279-317-3
EC Name:
Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)
Cas Number:
79828-43-6
Molecular formula:
C38H18Cl2CrN16O20S4.5Na
IUPAC Name:
Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Pirbright white strain (Tif: DHP),
10 male and 10 female animals were used in the test group and 5 male and 5 female in the control group, respectively. (initial weight was between 336 to 418 g).
The animals were housed individually in Macrolon cages(Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags, kept at a constant room temperture of 22 ± 3 °C, at a relative humidity of 30 to 70 % and a 12 hours light cycle day. The animals received ad libitum standard guinea pig pellets and fresh water.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
5 % FAT40210/D in physiological saline
Day(s)/duration:
Week 1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
40 % in Vaseline in epidermal induction.
Day(s)/duration:
One week after intradermal induction (week 2)
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline
Concentration / amount:
40 % in Vaseline in epidermal challenge.
Day(s)/duration:
Week 5
No. of animals per dose:
20
Details on study design:
0.1 ml of adjuvant /saline mixture, FAT 40210/D in physiological saline and FAT 40210/D in the adjuvant/saline mixture were injected simultaneously intradermal in to the shaved neck of the guinea pigs, and second induction was one week later with FAT 40210/D in vaseline was applied on a filter paper patch to the neck of the animals (patch 2x4 cm, approx 0.4 g paste per patch, occluded administration for 48 hours. Week 5, the animals were tested on the flank with FAT 40210/D in vaseline was applied (patch 2x2 cm, approx. 0.2 g paste per patch, occluded administration for 24 hours).
Challenge controls:
The group was treated with the vehicle as well as with the test articles to check the maximum subirritant concentration of the test article in adjuvant treated animals.
Positive control substance(s):
yes
Remarks:
strain sensitivity is tested once or twice per year with a known sensitizer (e.g. mercaptobenzothiazole, hexyl cinnamic aldehyde or potassium dichromate). Results of last three tests included in report.

Results and discussion

Positive control results:
None

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40 % in Vaseline
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: (test article control)
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
40 % in Vaseline
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: (test article control)
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 (vehicle control)
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 (vehicle control)
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
40 % in Vaseline
No. with + reactions:
15
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
40 % in Vaseline
No. with + reactions:
14
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Potassium dichromate ( Intradermal induction: 0.2%, Epidermal induction: 5%, Epidermal Challenge: 1%)
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: No reactions were seen with the side with vehicle only exposure

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
FAT 40210/D was found to be a strong sensitizer in albino guinea pigs testing.
Executive summary:

A key study was performed to determined skin sensitisation of FAT 40210 according to OECD Guideline 406 (Skin Sensitisation).

75 % and 65 % of the animals were sensitized by FAT 40210/D in the test group following challenge. And according to the maximization grading FAT 40210/D showed a strong grade of skin-sensitizing (contact allergenic) potential in albino guinea pigs, which shall be classified as skin sensitizer 1B according to CLP Regulation (Regulation EC No. 1272/2008).