4-dimethylaminobenzaldehyde

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 6, 2015 - July 13, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-dimethylaminobenzaldehyde

EC Number:

202-819-0

EC Name:

4-dimethylaminobenzaldehyde

Cas Number:

100-10-7

Molecular formula:

C9H11NO

IUPAC Name:

4-(dimethylamino)benzaldehyde

Test material form:

solid

Specific details on test material used for the study:

Designation: Art. 803057
Synonym: 4-(Dimethylamino)benzaldehyde
CAS-No.: 100-10-7
Batch: S6886257
Assay (GC, area%): 99.6% (a/a)
Appearance: Grey-blue, crystalline powder
Released until: May 31, 2019
Storage: Tightly closed, dark at room temperature (15 to 25°C)

PREPARATION OF THE TEST MATERIAL
The test item Art. 803057 was prepared as a 20% (w/v) suspension in a 0.9% sodium chloride solution. The stability in the vehicle was not investigated. The test item preparation was administered within <1 hour after preparation.

Test system

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

TEST MATERIAL: 750 µL (i.e. 150mg/750µL)

NEGATIVE / VEHICLE CONTROL: 750 µL

Designation: 0.9% sodium chloride solution
Supplier: B. Braun Melsungen AG, Germany
Batch: 13445011
Released until: September 2016

POSITIVE CONTROL: 750 µL

Designation: Art. 814223
Synonym: Imidazole
Supplier: Merck KGaA, Germany
Batch: S6746923
Released until: August 31, 2018
Imidazole was dissolved with 0.9% sodium chloride solution to a concentration of 20% (w/v)

Duration of treatment / exposure:

240 minutes

Number of animals or in vitro replicates:

in vitro: triplicate design

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

Run 1 / Experiment 1

Value:

21.7

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

not determinable

Other effects / acceptance of results:

OTHER EFFECTS:
- Visible damage on test system: No observations (e.g. tissue peeling, residual test chemical, non-uniform opacity patterns) were seen in a visually inspection of the corneas after treatment.

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: After treatment with the negative control (0.9% sodium chloride solution) the calculated IVIS was 0.7 and, thus, within three standard deviations of the current historical mean of the negative control (IVIS: -1.4 – 3.6).
- Acceptance criteria met for positive control: After treatment with the positive control (20% Imidazole) the calculated IVIS was 99.2 and, thus, also within two standard deviations of the current historical mean of the positive control (IVIS 74.7 – 138.6). Therefore, the study fulfilled the validity criteria.

Any other information on results incl. tables

		Opacity	Permeability	IVIS
				per cornea	per group (mean value)	SD
Negative control	0.9% NaCl Solution	1.845	-0.003	1.800	0.7	1.0
		0.383	0.000	0.388
		-0.064	-0.004	-0.124
Positive control	20% Imidazole solution	64.464	2.223	97.807	99.2	2.0
		59.362	2.808	101.486
		67.395	2.058	98.263
Test item	Art. 803057	24.942	-0.002	24.910	21.7	3.1
		18.783	-0.001	18.766
		21.504	-0.005	21.427

Applicant's summary and conclusion

Interpretation of results:

other: could not be determined

Conclusions:

Under the conditions of the present study, the eye hazard potential of the test item Art. 803057 (4-(Dimethylamino)benzaldehyde) cannot be predicted.

Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. Under the conditions of the present study, the eye hazard potential of the test item Art. 803057 (4-(Dimethylamino)benzaldehyde) cannot be predicted.