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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019

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)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Pyrolysis light oil from waste plastics
EC Number:
940-514-0
Molecular formula:
Not required for a UVCB-substance (mixture of multiple (>100) organic substances)
IUPAC Name:
Pyrolysis light oil from waste plastics
Test material form:
liquid: volatile

Test animals / tissue source

Species:
human

Test system

Vehicle:
other: Dulbecco`s Phosphate Buffered Saline
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
50 µL of the liquid test item were added to 1 mL of MTT solution in a 6-well plate and the mixture was incubated in the dark at 37 ± 1 °C, 5.0 ± 1 % CO2 and ≥ 95% relative humidity for 3 hours. 1 mL of MTT solution plus 50 µL of H2O demin. was used as negative control.
20 µL DPBS buffer and then incubated at 37 ± 1 °C, 5 ± 1 % CO2 and ≥ 95% relative hu-midity for 30 minutes. After that, 50 µL of the controls and the test item were applied in duplicate in one- minute- intervals
Duration of treatment / exposure:
28 minutes
Duration of post- treatment incubation (in vitro):
For post-treatment incubation, the tissues were incubated for 120 minutes
Number of animals or in vitro replicates:
two replicates for each tissue

Results and discussion

In vitro

Results
Irritation parameter:
other: %viability
Run / experiment:
1-3
Value:
> 0.8 - < 2.5
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, NAPHTHA is considered non-eye irritant in the EpiOcu-larTM Eye Irritation Test.
After treatment with the test item, the mean value of relative tissue viability was reduced to 87.9 %. This value is above the threshold for eye irritation potential (≤ 60%).