2-tert-butylhydroquinone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from experimental study reports

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

An eye irritation study was conducted to determine the eye irritating effects caused by the chemical.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-tert-butylhydroquinone

EC Number:

217-752-2

EC Name:

2-tert-butylhydroquinone

Cas Number:

1948-33-0

Molecular formula:

C10-H14-O2

IUPAC Name:

2-tert-butylbenzene-1,4-diol

Details on test material:

- Name of test material: 2-tert-butylhydroquinone
- Molecular formula: C10H14O2
- Molecular weight: 166.22
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

14 days

Observation period (in vivo):

1 hr,24 hr,48 hr,7 days and 14 days

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Hair around eye disc red

Basis:

mean

Time point:

other: 1 hr

Score:

3

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Slight irritation observed for unwashed eye

Results 2

Irritation parameter:

other: cornea appears dry,possible area of necrosis ~ 4mm diameter on conjunctiva

Basis:

mean

Time point:

other: 1 hr

Score:

1

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: for unwashed eye

Results 3

Irritation parameter:

other: watery discharge

Basis:

mean

Time point:

other: 1 hr

Score:

1

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: showed slight irritation for unwashed and washed eye.

Results 4

Irritation parameter:

other: purulent discharge

Basis:

mean

Time point:

other: 24 hrs. and 48 hrs.

Score:

2

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: slight irritation observed ; unwashed eye

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 7 days and 14 days

Score:

1

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: for unwashed eye

Irritant / corrosive response data:

Residual corneal damage and notched lids present at 14 days.

Any other information on results incl. tables

Summary	3 Unwashed
	Immed	1Hr	24 Hr	48Hr	Day 7	Day 14
Initial	Slight
Conjuctiva		Mod	Strong	Mod	Slight
Lids		Slight	Slight	Slight	Slight
Nict. Membrane		Slight	Mod	Slight
Corneal capacity			Mod	Mod	Slight	Slight
Iris
Adnexa stain			3/3
Corneal stain			3/3
Number normal	0/3	0/3*	0/3**	0/3***	2/3	2/3

Remarks:

* 1hr. – hair around eye disc red – 3/3 slight.

Cornea appears dry, possible area of necrosis ~4mmdiameter on conjuctive -1/3.

Water discharge – 1/3 slight.

 

** 24 hr. – purulent dischg – 2/3 slight.

*** 48hr. – purulent dischg – 2/3 slight.

7 days – pannus, lids notched – 1/3.

14 hays – pannus, lids notched - /3.

3 Washed
Immed	1Hr	24Hr	48Hr	Day 7	Day 14
	Slight	Slight
		Slight
	Slight	Slight	Slight
		2/3
		0/3
3/3	1/3*	1/3	2/3	3/3	3/3

Remarks:

*1 hr – watery dischg – 1/3.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The test substance when applied at 1.0 ml concentration to rabbit eye showed moderate to strong eye irritation.

Executive summary:

The eye irritation study was conducted to determine the adverse eye effects caused by the chemicals.

About 0.1 ml of undiluted test chemical was instilled into the eyes of each rabbit and the eyes were scored at 1 hr,24 hr,48 hr,7 days and 14 days.

The test chemical caused moderate to strong eye irritation, residual corneal damage and notched lid at 14 days. Thus the chemical can be considered as irritating to the eyes of treated rabbits.