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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study, glp

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension
Remarks:
migrated information: dispersion
Details on test material:
-

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
foreskin from multiple donors
Source strain:
not specified
Details on animal used as source of test system:
-
Justification for test system used:
-
Vehicle:
not specified
Control samples:
not required
Amount/concentration applied:
-
Duration of treatment / exposure:
-
Duration of post-treatment incubation (if applicable):
-
Number of replicates:
-

Test animals

Species:
other: not applicable (primary human keratinocytes were used for the skin model cultivation)
Strain:
other: human
Details on test animals and environmental conditions:
-

Test system

Type of coverage:
open
Preparation of test site:
other: not relevant, in vitro test
Vehicle:
other: moistened with 25 µL water
Controls:
not required
Amount / concentration applied:
-
Duration of treatment / exposure:
3 min and 60 min
Observation period:
not relevant according to guideline
Number of animals:
not relevant according to guideline, in-virto test

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: OD50
Value:
< 0.8
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
not valid
Remarks on result:
no indication of irritation

In vivo

Resultsopen allclose all
Irritation parameter:
other: ODS50
Basis:
mean
Time point:
other: 3 min
Score:
ca. 1.568
Max. score:
0.215
Reversibility:
other: not relevant according to guideline
Remarks on result:
other: in vitro test
Irritation parameter:
other: ODS50
Basis:
mean
Time point:
other: 60 min
Score:
1.201
Max. score:
0.293
Reversibility:
other: not relevant according to guideline
Remarks on result:
other: in vitro test

Any other information on results incl. tables

Table 1: MTT-results - 3 min treatment

3 min

Negative Control

Test Item

Positive Control

Tissue 1

Tissue 2

Tissue 1

Tissue 2

Tissue 1

Tissue 2

Absolute OD550values

1.693

1.588

1.608

1.529

0.208

0.211

1.727

1.580

1.585

1.541

0.215

0.212

1.700

1.571

1.643

1.500

0.224

0.221

OD550(mean of 3 aliquots)

1.707

1.580

1.612

1.523

0.216

0.215

OD550

(mean of 2 replicate tissues)

1.643*

1.568

0.215

Mean relative tissue viability [%]

100

95

13**

Inter tissue viability difference [%]***

7.7

5.7

0.4

Table 2: MTT-results - 60 min treatment

60 min

Negative Control

Test Item

Positive Control

Tissue 1

Tissue 2

Tissue 1

Tissue 2

Tissue 1

Tissue 2

Absolute OD550values

1.292

1.726

1.188

1.224

0.256

0.322

1.335

1.678

1.172

1.218

0.269

0.327

1.379

1.713

1.183

1.221

0.269

0.317

OD550(mean of 3 aliquots)

1.335

1.706

1.181

1.221

0.264

0.322

OD550

(mean of 2 replicate tissues)

1.521*

1.201

0.293

Mean relative tissue viability [%]

100

79

19**

Inter tissue viability difference [%]***

24.4

3.3

19.6

*          mean OD550 ≥ 0.8

**        mean relative tissue viability of the 3 min. positive control ≤ 30%

***       inter tissue viability difference ≤ 30%

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
tin sulphate showed under the test conditions no corrosive effects.