N-ethylpyridazin-4-amine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

equivalent or similar 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:

pre-guideline study

Deviations:

yes

Principles of method if other than guideline:

Study was conducted pre-guideline but according to a similar protocol. 50 µL bulk volume equivalent to 15 mg of the test substance were incubated for 6 hours followed by a 18-hours post-incubation period

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N-ethylpyridazin-4-amine

EC Number:

846-827-8

Cas Number:

1521274-68-9

Molecular formula:

C6H9N3

IUPAC Name:

N-ethylpyridazin-4-amine

Details on test material:

- State of aggregation: solid/brown

Test system

Details on study design:

- Details of the test procedure used:
Two tissue sample were incubated with the test substance for 6 hours, followed by a 18 hour post-incubation period. The extend of tissue destruction was determined by measuring mitochondrial dehydrogenase activity via MTT test.

- RhCE tissue construct used:
not specified
- Doses of test chemical and control substances used:
test chemical:
50 µL bulk volume (i.e. 15 mg) of undiluted test substance was applied;

negative control:
de-ionized water, sterile

positive control:
methyl acetate (98+%, CAS 79-20-9)

MTT reduction control:
test substance or de-ionized water, sterile

- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable):
duration:
6 hours incubation

post-incubation:
18 hours

- Number of tissue replicates used per test chemical and controls:
Two tissue samples were used per test chemical and each control

- Wavelength used for quantifying MTT formazan:
570 nm

- Description of the method used to quantify MTT formazan:
The formazan production of the test-substance treated epidermal tissues normalized to that of negative control tissues; the ratio of the values indicates the relative tissue viability

- Historic control data demonstrate reproducibility of results and robustness of the procedures

Results and discussion

In vitro

Results

Irritation parameter:

other: tissue viability %

Value:

ca. 3

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Based on the observed results and applying the evaluation criteria it was concluded that the test substance shows an eye irritation potential in the EpiOcular eye irritation test.