4-tert-butylbenzaldehyde

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

A Draize Test was conducted according to the method described in Fed. Reg. 38, No. 187, Para 1500.42, p. 27019 (27 Sept. 1973).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butylbenzaldehyde

EC Number:

213-367-9

EC Name:

4-tert-butylbenzaldehyde

Cas Number:

939-97-9

Molecular formula:

C11H14O

IUPAC Name:

4-tert-butylbenzaldehyde

Details on test material:

- Name of test material (as cited in study report): p-tertiaerbutyl-benzaldehyde
- Analytical purity: 98 %

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: males: 2.97 kg; female: 2.89 kg
- Housing: stainless steel wire mesh cages, one animal per cage
- Diet: Ovator Solikanin 4 mm (Muskator-Werke Duesseldorf), ca. 130 g per animal per day
- Water: ca. 250 ml VE water per animal per day from monday to friday and ca. 250 ml tap water per animal per day from saturday to sunday
- Acclimation period: ca. 8 days prior to start of the experiment

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 26 °C
- Humidity: 50 - 80 %
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye of the respective animal served as control

Amount / concentration applied:

Amount applied: 0.1 ml undiluted

Duration of treatment / exposure:

The substance was not washed out.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

6 animals; 4 males and 2 females

Details on study design:

Application volume: 0.1 ml into the conjunctival sac of the right eye
Readings: 1 h, 24 h, 48 h, 72 h and 8 d after the beginning of the application

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 6 animals

Time point:

other: 24-48-72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 6 animals

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all 6 animals

Time point:

other: 24-48-72 h

Score:

0.94

Max. score:

3

Reversibility:

fully reversible within: 8 d

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 6 animals

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Other effects:

Animal 1 was dead after 72 h.

Any other information on results incl. tables

Table 1: Individual scores for eye irritation effects

	animal	cornea	iris	conjunctiva redness	conjunctiva chemosis
24 h	1	1	0	2	0
	2	0	0	1	0
	3	0	0	1	0
	4	0	0	1	0
	5	0	0	1	0
	6	0	0	1	0
	animal	cornea	iris	conjunctiva redness	conjunctiva chemosis
48 h	1	1	0	2	0
	2	0	0	0	0
	3	0	0	1	0
	4	0	0	1	0
	5	0	0	1	0
	6	0	0	1	0
	animal	cornea	iris	conjunctiva redness	conjunctiva chemosis
72 h	1*	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0
	4	0	0	1	0
	5	0	0	1	0
	6	0	0	0	0
	animal	cornea	iris	conjunctiva redness	conjunctiva chemosis
8 d	1*	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0
	4	0	0	0	0
	5	1	0	0	0
	6	0	0	0	0

*Exitus

Mean scores

	animal	cornea	iris	conjunctiva redness	conjunctiva chemosis
mean           24- 72h	1*	1	0	2	0
	2	0	0	0.33	0
	3	0	0	0.67	0
	4	0	0	1	0
	5	0	0	1	0
	6	0	0	0.67	0
mean           24- 72h	1-6	0.17	0	0.94	0

* Due to exitus mean scores include 24 and 48 hours timepoints only.