Tin sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tin sulphate

EC Number:

231-302-2

EC Name:

Tin sulphate

Cas Number:

7488-55-3

Molecular formula:

O4S.Sn

IUPAC Name:

λ²-tin(2+) sulfate

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 or test system 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 vitro test

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 (3 min)

Value:

95

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

2 (60 min)

Value:

79

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

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 based on EU GHS criteria

Conclusions:

tin sulphate showed no corrosive effects under the test conditions.