Bis-sec-butyl peroxydicarbonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Date: July 17, 1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: the requirements of the Federal Hazardous Substances Act would be considered an eye irritant

Principles of method if other than guideline:

Prior to compound administration, the eyes of each rabbit were examined with ultraviolet light after instillation of one drop of a 2.0 percent sodium fluorescein solution. Rabbits exhibiting corneal lesions were discarded.
A volume of 0.1 ml of the test material was instilled into the cupped conjunctival sac of the right eye of each rabbit.
Examinations were made for ocular irritation at 24, 48 and 72 hours. At the 72 hour examination, sodium fluorescein and ultraviolet light were used to aid in revealing possible corneal injury.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis-sec-butyl peroxydicarbonate

EC Number:

243-424-3

EC Name:

Bis-sec-butyl peroxydicarbonate

Cas Number:

19910-65-7

Molecular formula:

C10H18O6

IUPAC Name:

2-[({[(butan-2-yloxy)carbonyl]peroxy}carbonyl)oxy]butane

Test material form:

liquid

Specific details on test material used for the study:

The test materials were received from the Lucidol Division, Pennwalt Corporation, Buffalo, New York, on June 12, 1970.
The test material was identified as follows:.
"Lupersol 22SM, Di (sec-Butyl) Peroxydicarbonate".
Each was received as a clear liquid packed in dry ice.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Nine male and 9 female albino New Zealand White rabbits weighing from 1858 to 2447 grams were used for this test. Each rabbit was housed individually in hanging metal cages and maintained in temperature and humidity controlled quarters throughout the test. Purina Rabbit Chow and water were available ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

72 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

The rabbits were divided into 3 groups of 3 male and 3 female rabbits each. Each group was used to examine one of the three test materials for eye irritation.
Prior to compound administration, the eyes of each rabbit were examined with ultraviolet light after instillation of one drop of a 2.0 percent sodium fluorescein solution. Rabbits exhibiting corneal lesions were discarded.
A volume of 0.1 ml of the test material was instilled into the cupped conjunctival sac of the right eye of each rabbit.
Examinations were made for ocular irritation at 24, 48 and 72 hours. At the 72 hour examination, sodium fluorescein and ultraviolet light were used to aid in revealing possible corneal injury.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

12.6

Max. score:

50

Reversibility:

not specified

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Score:

10.2

Max. score:

50

Reversibility:

not specified

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

8.2

Max. score:

50

Reversibility:

not specified

Any other information on results incl. tables

At each observation interval, conjunctival irritation in varying degrees was observed in each of the 6 animals tested. The irritation noted consisted of slight to moderate redness, slight to marked chemosis and very slight to slight discharge.

Seventy-two hours following instillation of the test material, each eye was examined with ultraviolet light and sodium fluorescein.

No corneal damage was observed.

Based upon the results obtained Lupersol 225M would be considered an eye irritant.

Eye irritation in the Rabbit:

Ocular Area		Average Scores (Range)
		Observation Period (hours)
		24	48	72
Cornea	A	0	0	0
	B	0	0	0
Cornea Score		0	0	0
Iris	A	0	0	0
Iris Score		0	0	0
Conjunctivae	A	1.9 (1.5-2.5)	1.7 (1.0-2.5)	1.3 (0.5-2.0)
	B	3.5 (3.0-4.0)	2.7 (2.0-4.0)	2.3 (2.0-2.5)
	C	0.9 (0.5-1.5)	0.7 (0.5-1.0)	0.5 (0.5)
Conjunctivae Score		12.6	10.2	8.2
Total Score		12.6	10.2	8.2

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Based upon the results obtained Lupersol 225M would be considered an eye irritant.

Executive summary:

Three test materials (Lupersol 223 , Lupersol 225M and D-199 P) were examined for eye irritation and dermal toxicity in the albino rabbit.

Each of the test materials when examined in accordance with the requirements of the Federal Hazardous Substances Act would be considered an eye irritant.

Based upon the results obtained Lupersol 225M would be considered an eye irritant.