Bis(2-ethylhexyl) peroxydicarbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-08-01 to 1995-08-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) peroxydicarbonate

EC Number:

240-282-4

EC Name:

Bis(2-ethylhexyl) peroxydicarbonate

Cas Number:

16111-62-9

Molecular formula:

C18H34O6

IUPAC Name:

3-({[({[(2-ethylhexyl)oxy]carbonyl}peroxy)carbonyl]oxy}methyl)heptane

Constituent 2

Reference substance name:

Di-(2-Ethylhexyl)-Peroxydicarbonate

IUPAC Name:

Di-(2-Ethylhexyl)-Peroxydicarbonate

Details on test material:

- Name of test material (as cited in study report): Luperox 223-M-75 (Di-(2-Ethylhexyl)-Peroxydicarbonate)
- Substance type: organic peroxide
- Physical state: colourless liquid
- Analytical purity: 75.8 % in hydrocarbon
- Lot/batch No.: 802-9409-01
- Storage condition of test material: at -20°C and protected from light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2.4 kg +/- 0.2 kg
- Housing: individually
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Remarks:

the substance was used in original form (75.8% in hydrocarbon)

Controls:

other: untreated skin served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of the test substance in active material corresponding to 0.66 ml in the finished product
- Concentration (if solution): 75.8 % in hydrocarbon

Duration of treatment / exposure:

The test substance was applied in a first assay for a period of 3 min and 4 h in one male New Zealand white rabbit. Since the substance was not strongly irritating in the first assay, it was applied for 4 h in a second assay.

Observation period:

The observation period was extended to a maximum of 14 days (until day 15) in order to determine the progress of lesions and their reversibility.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm^2
- Type of wrap if used: dry gauze pad

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped of with moistened (4 h exposure) or dry (3 min exposure) gauze pad
- Time after start of exposure: 3 min or 4 h

SCORING SYSTEM: scoring scale 0-4 see table 1 in "any other information on materials and methods"

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 3 min

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 11 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 4 h

Score:

>= 0 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 11 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 4 h

Score:

>= 0 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 4 h

Score:

>= 0 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 4 h

Score:

>= 0 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 4 h

Score:

>= 0 - <= 4

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 4 h

Score:

>= 0 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 5 days

Other effects:

dryness of the skin observed in all animals latest on day 5 after 4 h exposure and on day 7 after 3 min exposure

Any other information on results incl. tables

Table 2: Mean irritant response data after 4 h exposure at day 2, 3 and 4

Rabbit number	Dermal Irritation	Mean irritation score (#)	Interpretation
1	Erythema	1.3	(-)
	Oedema	0.7	(-)
	Other	Dryness of skin from day 7 onwards
2	Erythema	2.0	(+)
	Oedema	3.3	(+)
	Other	Dryness of skin from day 5 onwards
3	Erythema	2.0	(+)
	Oedema	2.0	(+)
	Other	Dryness of skin from day 5 onwards

(#) mean irritation score on days 2, 3 and 4

(+) = irritant according to E.E.C. criteria

(-) = non-irritant according to E.E.C. criteria

 

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions, the test substance Di-(2-Ethylhexyl)-peroxycarbonate was considered irritant in rabbits. All effects were reversible.

Executive summary:

In a primary dermal irritation study according to the OECD guideline 404, 3 male rabbits (New Zealand white; 2.4 +/-0.2 kg) were dermally exposed to 0.5 ml of Di-(2-Ethylhexyl)-peroxydicarbonate (undiluted test material; 75.8 % in hydrocarbon) which corresponds to 0.66 ml in the finished product. The test sites were covered with a semi-occlusive dressing for 3 minutes and 4 hours, respectively. Animals were then observed for 14 days until day 15. The mean values of the scores for erythema and oedema were calculated for each animal.

After 3 minutes exposure very slight erythema (grade 1) was observed up to day 7; dryness of the skin was noted from day 7 onwards, masking evaluation of the erythema up to day 10.

After 4 hours of exposure very slight or slight erythema (grade 1 or 2) was observed up to days 4, 6 or 7. Slight or severe oedema (grade 2 and 4) was noted for 24 h in one animal, and up to day 4 in another animal. In the remaining rabbit, slight oedema was noted from days 2 to 4.

Dryness of the skin was observed from day 5 (two rabbits) or 7 to days 11, 13 or 15. It masked evaluation of erythema in one rabbit on day 5 and in animal on days 8 to 10.

Mean scores over 24, 48 and 72 hours for individual animals were 1.3, 2.0 and 2.0 for erythema and 0.7, 3.3 and 2.0 for edema.

In this study, Di-(2-Ethylhexyl)-peroxydicarbonate is a dermal irritant to the skin.