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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
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
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:
09 Oct 2017
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
BASF SE Experimental Toxicology and Ecology 67056 Ludwigshafen, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Content of water 4% (w/w)
Content of ammonium chloride 0.6% (w/w)
Batch 160001/3 UF
Storage room temperature
Specific details on test material used for the study:
purity: 95.4%
content of water 4%
content of ammonium chloride 0.6%
physical state: fine powder, blue

Test animals / tissue source

Species:
human
Strain:
other: not applicable
Details on test animals or tissues and environmental conditions:
The EpiOcularTM model (OCL-200) is a three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratinozytes used to model the human corneal epithelium. The EpiOcularTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm diameter) and are commercially available as kits (EpiOcular™ 200), containing 24 tissues on shipping agarose.

To assess the ability of the test material to directly reduce MTT a pretest was performed.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: yes (tissue incubations for positive and negative controls included)
Amount / concentration applied:
bulk volume of ca. 50 μL
Duration of treatment / exposure:
6 hours
Duration of post- treatment incubation (in vitro):
18h
Number of animals or in vitro replicates:
Two tissue samples were used per group.
Details on study design:
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The
quotient of the values indicates the relative tissue viability.

Results and discussion

In vitro

Results
Irritation parameter:
other: viability
Remarks:
[%]
Run / experiment:
mean
Value:
81
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid

Any other information on results incl. tables

Methyl acetate was used as positive control and deionised water as negative control and both gave the results to satisfy acceptance criteria.

Methyl acetate decreased the mean viability to 12 % of control cultures.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the EpiOcular test (OECD 492, GLP), the substance was found to be non irritating to eyes.