Methanesulfonic acid, 1,1'-(1,6-hexanediyldiimino)bis[1-oxo-, sodium salt (1:2)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable and well documented

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Principles of method if other than guideline:

The modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain Crl:NMRI BR (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item Katalysator W AZ 5596-B.

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt

EC Number:

690-526-2

Cas Number:

38632-47-2

Molecular formula:

C8H14S2N2O8.Na2

IUPAC Name:

Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt

Details on test material:

content: 31.94% hexamethylenediisocyanate-bisulfiteadduct (not used for calculation)

In vivo test system

Test animals

Species:

mouse

Strain:

NMRI

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

other: Pluronic PE 9200 / 0.9% NaCl solution 1 % vIv

Concentration:

Group 1 Vehicle (Pluronic PE 9200 / 0.9% NaCl solution 1 % vIv)
Group 2 2% Isotan LP RJE 69140 (in Pluronic PE 9200 / 0.9% NaCl solution 1 % vIv)
Group 3 10% Isotan LP RJE 69140 (in Pluronic PE 9200 / 0.9% NaCl solution 1 % vIv)
Group 4 50% Isotan LP RJE 69140 (in Pluronic PE 9200 / 0.9% NaCl solution 1 % vIv)

No. of animals per dose:

6 animals/test item group and 6 control animals

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: see Remark

Remarks:

1. Direct LLNA (NMRI mice, female, 6 animalsl group) Dose (%) Weight index Cell count index (index of mean +/-SD in %) 0 1.00 +/-18.53 1.00 +/-23.24 2 1.16 +/-23.50 1.13 +/-16.65 10 1.32 +/-16.21 1.26 +/-27.83 50 1.10 +/-16.16 1.18 +/-18.50 Ear swelling (NMRI mice, female, 6 animals/group, in 0.01 mm) Dose (%) day 1 day4 Index day4 (mean +/- SD in %) 0 18.25 +/- 7.06 18.00 +/- 4.74 1.00 2 18.33 +/- 4.84 18.17 +1- 6.98 1.01 10 18.33 +/- 4.25 17.92 +/- 3.73 1.00 50 18.42 +/- 3.63 17.83 +/- 3.24 0.99 Ear weight (NMRI mice, female, 6 animals/group, in mg per 8 mm diameter punch) Dose (%) day4 Index day4 (mean +/- SD in %) 0 11.51 +/-5.44 1.00 2 11.17 +/- 8.12 0.97 10 11.45 +/- 4.45 0.99 50 11.36 +/- 6.90 0.99

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: not applicable

Any other information on results incl. tables

Compared to vehicle-treated animals, none of the parameters measured in the substance treated groups, i.e. cell counts and weights of the draining lymph nodes, ear weights and ear swelling, reached or exceeded the "positive levels" defined for this assay.

These results show that there is no indication for a skin sensitizing effect after administration of a concentration of up to and including 50% Isotan LP RJE 69140 in this test system.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Executive summary:

A modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain Hsd Win:NMRI (6 animals/ test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of

the test item Isotan LP RJE 69140.

The study was conducted according to OECD Guidelines No. 429 and No. 406, EC Guideline 2004/73IEC (29th Adaptation of Guideline 67/5481EEC, B.42)lHealth Effects Test Guideline and OPPTS 870.2600 (EPA) with the following test item concentrations:

o (vehicle control), 2%, 10% and 50%.

The test item was formulated in Pluronic PE 9200 I 0.9% NaCl solution 1 % v/v to yield an emulsion in the low concentration and a solution in the mid and the high concentration.

Compared to vehicle-treated animals, none of the parameters measured in the substance treated groups, i.e. cell counts and weights of the draining lymph nodes, ear weights and ear swelling, reached or exceeded the "positive levels" defined for this assay.

These results show that there is no indication for a skin sensitizing effect after administration of a concentration of up to and including 50% Isotan LP RJE 69140 in this test system.

In conclusion, these results show that the test item Isotan LP RJE 69140 has no sensitizing potential in rnice after dermal application of up to and including a 50% concentration. No indication for a non-specific (irritant) activation was detected, too. Therefore, the

concentration of 50% tumed out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.