2-tert-butylhydroquinone

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 peer reviewed journal

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: as mentioned below

Principles of method if other than guideline:

Skin irritation study was condcuted to determine the skin irritation potential of test 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

Species:

guinea pig

Strain:

not specified

Test system

Type of coverage:

other: rubber dam cuff

Preparation of test site:

not specified

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

0.25-1.00 g/kg

Duration of treatment / exposure:

48 hrs

Observation period:

2 weeks

Number of animals:

Not specified

Details on study design:

Not specified

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hr and 48 hrs

Reversibility:

no data

Remarks on result:

other: Dose : 0.25 - 1.0 g/kg, moderate skin irritant

Irritant / corrosive response data:

No escars or scarring were present at 2 weeks , superficial necrosis occurred during the period of exposure . No evidence of percutaneous absorption.

Any other information on results incl. tables

SUMMARY
DOSE	MAXIMUM EFFECT			WEIGHT CHANGE
g/Kg	SKIN 24/48 Hrs	SKIN 2 WEEKS	SYSTEMIC	1 WEEK	2WEEK
0.25	Mod ery/edema	Normal		+32	+67
0.50	Slt necrosis	Normal		+2	+33
1.00	Mod necrosis	Normal		+16	+43
1.00	Slt necrosis	Normal		+17	+59
1.00	Slt necrosis	Normal		-4	+47

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test substance when applied at 0.25-1.0 g/kg concentration to guinea pig skin showed moderate irritation . Hence the test chemical was considered as irritating to the skin.

Executive summary:

The skin irritation study was conducted on guinea pigs to assess the skin irritation potential of test chemical.

The test chemical was applied on each guinea pig at concentration of 0.25-1.0 g/kg by using rubber dam cuff.

Although no escars or scarring were present at 2 weeks, superficial necrosis occurred during the period of exposure. No evidence of percutaneous absorption.

Thus the test chemical can be considered as moderately irritating to the skin of treated guinea pigs.