N,N-bis(1-methylethyl)formamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 30 Mar 2021 to 01 Apr 2021

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N,N-bis(1-methylethyl)formamide

EC Number:

220-284-1

EC Name:

N,N-bis(1-methylethyl)formamide

Cas Number:

2700-30-3

Molecular formula:

C7H15NO

IUPAC Name:

N,N-Diisopropylformamide

Specific details on test material used for the study:

Batch number: M-O303190723301F
Purity: 99.68%

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

SOURCE OF COLLECTED EYES
- Source: Bovine eyes (from cattle at least six months old) were obtained from a local abattoir by Spear Products (Coopersburg, PA) and transported to MB Research in Hanks’ Balanced Salt Solution (HBSS) with penicillin-streptomycin on ice, in an insulated cooler, on 01 Apr 2021.
- Selection and preparation of corneas: The eyes were examined after receipt from the abattoir. Any cornea with gross abnormalities (e.g., neovascularization, pigmentation, opacity or scratches) was discarded.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

0.75 ml

Duration of treatment / exposure:

10 minutes

Duration of post- treatment incubation (in vitro):

2 hours

Number of animals or in vitro replicates:

3

Details on study design:

NUMBER OF REPLICATES: 3

NEGATIVE CONTROL USED: MEM

POSITIVE CONTROL USED: 100% Ethanol

TREATMENT METHOD: closed chamber

POST-INCUBATION PERIOD: yes

REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After 10 (± 1) minutes, the test and control
articles were removed from the epithelium of the corneas and anterior chamber of the holder by washing with MEM containing phenol red. A final rinse was made with MEM without phenol red. The anterior and posterior chambers of the holders were then refilled with fresh MEM.
- POST-EXPOSURE INCUBATION: All corneas were incubated at 32 (± 1)°C for an additional two hours, MEM was then removed and replenished in each cornea holder.

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity of each cornea was measured by comparing the treated cornea to the blank supplied with the opacitometer.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of Spectronic 20-D Colorimeter Spectrophotometer (OD490)

SCORING SYSTEM: In Vitro Irritancy Score (IVIS)

DECISION CRITERIA: the decision criteria as indicated in the TG was used.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

58.08

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The test substance is eye corrosive.

Executive summary:

The Bovine Corneal Opacity and Permeability Test is performed on the test substanc. The IVIS value is 58.08, the test substance is eye corrosive.