reaction mass of: pentasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate;tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;tetrasodium 4-amino-5-hydroxy-6-[(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(2-hydroxyethylsulfonyl)-phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[-2-sulfonato-4-(2-hydroxyethylsulfonyl)phenylazo]naphthalene-2,7-disulfonate

Endpoint summary

Description of key information

Skin sensitizer

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Additional information:

Bulher test (OECD 406)

Twenty male animals of the test group were treated topically with Navy MGi 1571 at 50 % in pEG 300 once a week for a 3 week induction phase. Two weeks after the final  induction application the animals were challenged with the same test item concentration of 50 % in PEG 300 as used for induction.
The ten animals of the control group were not treated during the induction. They were treated once at challenge with Navy MGi 1571 at 50 % in PEG 300.
Eleven (at the 24-hour reading) and fifteen (at the 48-hour reading) out of 20 test animals were observed with discrete/patchy to moderate/confluent erythema after the challenge treatment with the highest tested non-irritating concentration of Navy MGi 1571 at 50 % in PEG300.
No skin reactions were observed in the control group treated in the same conditions during the challenge phase.
Based on the above mentioned findings in a non-adjuvant sensitization test in guinea pigs Navy MGi 1571 applied at a
concentration of 50 % in PEG 300 was found to be as a skin sensitizer.

LLNA assay (OECD 429)

Three groups each of four female mice were treated daily with the test item at concentrations of 5 %, 10 %, and 25 % (w/v) in ethanol:water, 7:3 (v/v) by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. A control group of four mice was treated with the vehicle (ethanol:water=7:3 (v/v)) only. Five days after the first topical application the mice
were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a pscintillation counter.
No test item-related clinical signs were observed. All treated animals survived the scheduled study period.
ln this study STIMULATION INDICES of 9.0, 7.9 and 16.7 were determined with the test item at concentrations of 5 %,10 % and 25 % (w/v) in ethanol:water, 7:3 (v/v).
A test item is regarded as a sensitizer in the LLNA if the exposure to one or more test concentrations resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the STIMULATION lNDEX (S.I.).
The test item Navy MGi 1571 was found to be a sensitizer.

Justification for classification or non-classification

The test substance was found to have positive results in the two skin sensitisation tests carried out according to the OECD 406 and 429, respectively, according to the criteria set out in the CLP Regulation 1272/2008.

It is therefore classified as Skin Sens Cat. 1. A harmonized classification also applies for the test substance.