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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Principles of method if other than guideline:

A gauze patch with 500 µl of the test item was applied on the left side of the dorsal area of 3 rabbits. The patch was fixed with a semi-occlusive dressing and held in contact with the skin throughout a 4-hour period. At the end of the exposure period, the residual test item was removed with aqua ad injectionem. The animals were examined for signs of erythema and edema 1 hour after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and edema 24, 48 and 72 hours after the patch removal.

GLP compliance:

yes

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:

Name: 1,1´-(1,6-Hexanediyldiimino)bis[1-oxo]-methanesulfonic acid, sodium salt (1:2)
Common Name: X-Tan
CAS No.: 38632-47-2
Physical State at RT: powder
Colour: white
Density: 1.218 kg/L
Molecular Weight of Base Form: 376.3 g/mol
pH: 2.5 to 5
Active Components: 84.5%

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other:

Vehicle:

water

Controls:

not required

Duration of treatment / exposure:

4 hours

Observation period:

3 days

Number of animals:

3 animals

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicalbele - score = 0 at any time point

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, and 72 h

Score:

0

Max. score:

4

Reversibility:

other: score = 0 at any time point

Any other information on results incl. tables

No irritant or corrosive effects were observed on the intact skin of the three female rabbits (strain NZW) after a contact time of 4 hours.

Neither mortalities nor significant clinical signs of toxicity were observed. There were no significant body weight changes during the contact and observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Executive summary:

A gauze patch with 0.5 g of tthe test item was applied on the left side of the dorsal area of 3 rabbits. The patch was fixed with a semi-occlusive dressing and held in contact with the skin throughout a 4-hour period. At the end of the exposure period, the residual test item was removed with aqua ad injectionem. The animals were examined for signs of erythema and edema 1 hour after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and edema 24, 48 and 72 hours after the patch removal.

Under the conditions of the present study, the single dermal application of the test item 1,1´-(1,6-Hexanediyldiimino)bis[1-oxo]- methanesulfonic acid, sodium salt (1:2) to three rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.