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Toxicological information

Eye irritation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
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)

Test material

Constituent 1
Chemical structure
Reference substance name:
Molybdenum, bis(N,N-dibutylcarbamodithioato-κS,κS')dioxodi-μ-thioxodi-, stereoisomer
EC Number:
825-571-0
Cas Number:
60428-79-7
Molecular formula:
C18H36Mo2N2O2S6
IUPAC Name:
Molybdenum, bis(N,N-dibutylcarbamodithioato-κS,κS')dioxodi-μ-thioxodi-, stereoisomer
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
human

Test system

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"

Results and discussion

In vitro

Results
Irritation parameter:
other: mean tissue viability (& of control)
Value:
104
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.

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