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Description of key information

Effects on skin irritation/corrosion: irritating

Based on the pH-value of 2.5 w/w % solution of SnSO4is < 2, it is to assume that the substance causes corrosive or severe irritant effect on skin. The available in vitro study on skin corrosion was negative, hence the substance is considered to cause skin irritation.



Effects on eye irritation: corrosive

no study available, however the pH-value of 2.5 w/w % solution of SnSO4 is < 2. So it is to assume that the substance causes corrosive or severe irritant effect in eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes
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:
-
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:
-
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
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
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

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%

Interpretation of results:
other: not corrosive based on EU GHS criteria
Conclusions:
tin sulphate showed no corrosive effects under the test conditions.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a strong acid (pH <= 2.0) or base (pH => 11.5) and the available information indicates that it should be classified as serious eye damage (Category 1)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Effects on skin irritation/corrosion: irritating

Based on the pH-value of 2.5 w/w % solution of SnSO4 is < 2, it is to assume that the substance causes corrosive or severe irritant effect on skin. The available in vitro study on skin corrosion was negative, hence the substance is considered to cause skin irritation. This outcome is supported by a human case study.



Effects on eye irritation: corrosive

No study available, however the pH-value of 2.5 w/w % solution of SnSO4 is < 2. So it is to assume that the substance causes corrosive or severe irritant effect in eyes.

So as worst case assumption the substance is classified as Eye damage 1 (H318) and as Skin irritant (H315) according to Regulation (EC) No 1272/2008.

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