Molybdenum, bis(N,N-dibutylcarbamodithioato-κS,κS')dioxodi-μ-thioxodi-, stereoisomer

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

July 2015

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Version / remarks:

July 2012 (REG (EC) No. 440/2008 amended by REG (EC) No. 640/2012)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

validated in vitro test model for sequential testing strategy

Vehicle:

unchanged (no vehicle)

Details on test system:

see attached documents "S-600- Skin irritation Study Design.pdf"

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 11.8-13.2 mg

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL
- Concentration (if solution): neat

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL
- Concentration (if solution): 5% SDS in PBS

Duration of treatment / exposure:

15 ± 0.5 min

Duration of post-treatment incubation (if applicable):

42 h

Number of replicates:

3

Irritation / corrosion parameter:

% tissue viability

Value:

121

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

for detailed results see attached document "S-600 - Skin irritation Results.pdf"

Interpretation of results:

GHS criteria not met

Conclusions:

no classification according to REGULATION (EC) 1272/2008

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Version / remarks:

July 2016

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: EU Method B.40 BIS (In Vitro Skin Corrosion: Human Skin Model Test)

Version / remarks:

May 2008 (REG (EC) No. 440/2008)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

validated in vitro test model for sequential testing strategy

Vehicle:

unchanged (no vehicle)

Details on test system:

see attached documents "S-600 - Skin corrosion Study Design.pdf"

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 39.3-45.5 mg

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 8N KOH

Duration of treatment / exposure:

3 min and 1 hour

Number of replicates:

4 (two for the 3-minute exposure and two for the 1-hour exposure)

Irritation / corrosion parameter:

% tissue viability

Remarks:

3-min exposure

Value:

90

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Irritation / corrosion parameter:

% tissue viability

Remarks:

1-h exposure

Value:

93

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

for detailed results see attached document "S-600 - Skin corrosion Results.pdf"

Interpretation of results:

GHS criteria not met

Conclusions:

no classification according to REGULATION (EC) 1272/2008

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Version / remarks:

October 2017

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

human

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 60 mg

Duration of treatment / exposure:

6 hours ± 15 minutes

Duration of post- treatment incubation (in vitro):

18 hours ± 15 minutes

Number of animals or in vitro replicates:

2 tissues

Details on study design:

see attached documents "S-600 - Eye irritation (EpiOcular) Study Design.pdf"

Irritation parameter:

other: mean tissue viability (& of control)

Value:

104

Negative controls validity:

valid

Positive controls validity:

valid

for detailed results see attached document "S-600 - Eye irritation (EpiOcular) Results.pdf"

Interpretation of results:

GHS criteria not met

Conclusions:

Since the mean relative tissue viability for S-600 was above 60% S-600 is considered to be non-irritant, i.e. no classification according to REGULATION (EC) 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In the in vitro skin irritation/corrosion and eye irritation tests no adverse effects were obsserved. No classification according to REGULATION (EC) 1272/2008.