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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The HCE is produced and commercialized since 2000 - more than 11 years -, and is the only model made from human corneal cells. The model is routinely used by the major Cosmetic and Pharmaceutical companies, and has already been prevalidated in 2004. Furthermore, this model is recognized as the model of choice and scientifically relevant as documented by several publications.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The experiment was carried out on reconstituted human ocular epithelia (SkinEthic™ Human Corneal Epithelial Model (HCE)); The model used for this study is a corneal epithelial tissue (mucosa) without a stratum corneum. The ultra-structure (tissue morphology and thickness) is similar to the corneal mucosa of the human eye
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
6331-96.-0
IUPAC Name:
6331-96.-0
Test material form:
other: solid
Details on test material:
Purity: 98.9%

Test animals / tissue source

Species:
other: in vitro
Strain:
other: in vitro; reconstituted human ocular epithelia

Test system

Vehicle:
other: moistened with PBS
Controls:
other: negative and positive controls included
Duration of treatment / exposure:
Human Corneal Epithelial (HCE) inserts were exposed to 30 mg of the test item for 60 min (RT; three inserts per period of incubation time).
Observation period (in vivo):
After the exposure period of 60 minutes the inserts were washed carefully with PBS. After a post-exposure incubation of 16h in the incubator MTT reduction assay was performed.
Duration of post- treatment incubation (in vitro):
60 min.
Number of animals or in vitro replicates:
In vitro; three inserts per period of incubation time.

Results and discussion

In vitro

Results
Irritation parameter:
other: Cell viability in %
Run / experiment:
Decision criteria: ocular irritant if cell viability
Value:
77.3
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:
No indication for an eye irritant potential was seen in an in vitro test.
Executive summary:

Dichlororthanilsaure was not characterised by a significant impact on cell viability after test item exposure.

Thus, Dichlororthanilsaure is identified as non-irritant under the conditions of this in vitro assay.