Registration Dossier

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:
Deviation: Concerning:
Provided Materials, study plan, p. 11
Study Plan: vial methyl acetate, CAS No. 79-20-9 (positive control)
Report:Methyl acetate was not provided with the kit.

Deviations:
yes
Remarks:
This deviation did not influence the quality or integrity of the present study
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,10-dichlorodecane
EC Number:
218-489-6
EC Name:
1,10-dichlorodecane
Cas Number:
2162-98-3
Molecular formula:
C10H20Cl2
IUPAC Name:
1,10-dichlorodecane
Test material form:
liquid

Test animals / tissue source

Species:
human
Details on test animals or tissues and environmental conditions:
This test uses the three-dimensional RhCE EpiOcular™ (MatTek). It consists of normal, human-derived epidermal keratinocytes and mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium. The MatTek EpiOcular™ model has been widely used as a research and testing model for many years.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
. Negative Control 50 µL Aqua dest.
2. Positive Control 50 µL methyl acetate
3. Test Item 50 µL (undiluted)

Duration of treatment / exposure:
30 ± 2 min at 37 °C +/-1 °C, 5.0% CO2 / 95% air
Duration of post- treatment incubation (in vitro):
ca. 5h
Number of animals or in vitro replicates:
The test was performed on a total of 2 tissues per dose group.

Results and discussion

In vitro

Results
Irritation parameter:
other: Mean Tissue Viability %
Run / experiment:
Mean
Value:
102
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

The potential of the test item to induce eye irritation was analysed by using the three-dimensional human corneal epithelium model EpiOcularä, consisting of normal, human-derived epidermal keratinocytes mimicking characteristics of the corneal epithelium. In the present study 1,10-Dichlorodecane was applied topically to the EpiOcularätissue for 30 min followed by 12 min post-soaking incubation after removal of the test item. After a 120 min post-treatment period cytotoxic effects were determined via MTT reduction assay. Ocular irritation potential of the test item was predicted from the relative mean tissue viabilities compared to the negative control tissues concurrently treated with Aqua dest. The mixture of 50 µL test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple.Therefore, NSMTT equalled 0%. The mixture of 50 µL test item per 1 mL A. dest. and per 2 mL isopropanol showed no colouring as compared to the solvent.Therefore, NSCliving equalled 0%. The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 60% (102.1%). The controls confirmed the validity of the study. The mean absolute OD570 of the two negative control tissues was> 0.8 and < 2.5 (1.814). The mean relative tissue viability (% negative control) of the positive control was < 50% (20.5%). The maximum inter tissue difference of replicate tissues of all dose groups was < 20% (4.4%).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study under the given conditions the test item showed no irritant effects. The test item is classified as “non-irritant“ in accordance with UN GHS “No Category”.

Executive summary:

In the present study theeye irritating potential of 1,10-Dichlorodecane was analysed. Since irritant substances are cytotoxic to the corneal epithelium after a short time exposure the cytotoxic effects of the test item on EpiOcular, a reconstituted three-dimensional human corneal epithelium model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 30 min exposure period and 120 min post-treatment period and compared to those of the concurrent negative controls.

The mixture of 50 µL test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple.Therefore, NSMTT equalled 0%.

The mixture of 50 µL test item per 1 mL A. dest. and per 2 mL isopropanol showed no colouring as compared to the solvent. Therefore, NSCliving equalled 0%.

The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 60% (102.1%).