Tin sulphate

Endpoint summary

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

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.