Dibutyl peroxydicarbonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 1976

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: FDA Fed. Reg. 28 (119), 5582, 1963

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyl peroxydicarbonate

EC Number:

240-344-0

EC Name:

Dibutyl peroxydicarbonate

Cas Number:

16215-49-9

Molecular formula:

C10H18O6

IUPAC Name:

1-({[(butoxycarbonyl)peroxy]carbonyl}oxy)butane

Specific details on test material used for the study:

- Name of the test material: Trigonox NBP-C 50 (di-n. butyl peroxydicarbonate)
- Appearance: liquid
- Purity: 50% solution in Shellsol T
- Storage condition of test material: stored at -20 ˚C until use

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: Animals are caged individually and receive no hay or extraneous material that might enter the eye

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test substance

Duration of treatment / exposure:

The test substance is applied to the uppler and lower eye lid, which are then carefully closed and subsequently held together for at least one second. The eyes are not washed following the application of the test material and the animals are released immediately.

Observation period (in vivo):

The eyes are examined at 24, 48, 72 h and 7 days after instillation of the test material.

Number of animals or in vitro replicates:

6 per test material

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The eyes are not washed following the application of the test material and the animals are released immediately

SCORING SYSTEM:
- The test is considered positive if four or more of the animals in the test group of six rabbits exhibit a positive reaction
- If one animal exhibits a positive reaction, the test is regarded as negative
- If two or three animals exhibit a positive reaction, the test is repeated, using a different group of six animals.
- The second test is considered positive if three or more of the animals exhibit a positive reaction.
- If only one or two animals in the second test exhibit a positive reaction, the test is again repeated with a different group of six animals.
- If a third test is needed, the substance will be regarded as an irritant if two or more animals exhibit a püositive response.

TOOL USED TO ASSESS SCORE: binocular

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

mean

Remarks:

of six animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.667

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Remarks on result:

probability of mild irritation

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

not fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 13

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Remarks on result:

probability of mild irritation

Results 14

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

For detailed results please refer to Table 1 in box "Any other information on results incl tables".

Other effects:

- Lesions and clinical observations: The eye lesions caused by the test item was of a slight degree.

Any other information on results incl. tables

Table 1: Individual scores awarded to the ocular lesions elicited by Trigonox NBP-C 50

Animal No.	Cornea	Iris	Conjunctivae
			Redness	Chemosis
After 24 hours
1	0	0	2	3
2	0	0	1	1
3	0	0	1	1
4	0	0	1	0
5	0	0	1	0
6	0	0	>1	1
After 48 hours
1	0	0	1	1
2	0	0	0	0
3	0	0	1	0
4	0	0	0	0
5	0	0	1	0
6	0	0	1	1
After 72 hours
1	0	0	1	0
2	0	0	0	0
3	0	0	1	1
4	0	0	0	0
5	0	0	1	0
6	0	0	1	1
After 7 days
1	0	0	1	0
2	0	0	0	0
3	0	0	0	0
4	0	0	0	0
5	0	0	0	0
6	0	0	1	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions reported, the test substance Trigonox NBP-C 50 showed only slight irritant effects in the eye of New Zealand White rabbits. Based on the results and in accordance with the CLP criteria, no classification is warranted.

Executive summary:

In a primary eye irritation study conducted similar to OECD test guideline 405, 0.1 mL of Trigonox NBP-C 50 was instilled into the upper and lower eye lid of one eye of each of six New Zealand White rabbits. Animals were observed for a total of 7 days. Scoring was conducted 24 h, 48 h, 72 h and 7 days after test substance administration. Eye lesions were scored by the method of Draize. Only slight irritant effects were observed, which were fully reversible within 7 days at latest. Only in two animals a conjunctivae redness score of 1 was still recorded after 7 days. Based on the results and in accordance with the CLP criteria, no classification is warranted.