Ditetradecyl peroxydicarbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-10-05 to 1992-10-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

Directive 84/449/EEC

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ditetradecyl peroxydicarbonate

EC Number:

258-436-4

EC Name:

Ditetradecyl peroxydicarbonate

Cas Number:

53220-22-7

Molecular formula:

C30H58O6

IUPAC Name:

1-[({[(tetradecyloxy)carbonyl]peroxy}carbonyl)oxy]tetradecane

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: approximately three and a half months old
- Weight at study initiation: 2.38 - 2.85 kg
- Housing: in a lagomorph room within a limited- access buiding
- Diet: free access to a commercially available standard pelleted rabbit diet
- Water: free access to tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 22 °C
- Humidity: 45 - 56 %
- Air changes: 15 complete air changes per hour without re-circulation
- Photoperiod: a lighting cycle of 12 hours of artificial light per day

IN-LIFE DATES: From: 1992-10-05 To: 1992 10-22

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:

single treatment

Observation period:

72 hours

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: 3 x 2 cm
- Type of wrap if used: unmedicated gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing: washed with warm water and dried with paper towels to remove excess test material adhering to the skin
- Time after start of exposure: 4 hour

SCORING SYSTEM:
Criteria for assessment of skin irritation responses:
1) Erythema and eschar formation:
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well-defined erythema: 2
- Moderate to severe erythema: 3
- Severe (beet redness) to slight eschar formation (injury in depth) : 4

2) Oedema formation:
- No oedema: 0
- Very slight oedema (barely perceptible): 1
- Slight oedema (edges of area weel-defined by definite raising): 2
- Moderate oedema (raised approximately 1 mm): 3
- Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No dermal response was observed at the test site of any animal at any time during the 72 hour observation period.
The control sites did not show any response to the control procedure.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Ditetradecyl peroxydicarbonate was classified as non-irritant to the skin.

Executive summary:

The potential of ditetradecyl peroxydicarbonate to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 g of the test material to the closely-clipped dorsa of three New Zealand White rabbits for four hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings. No dermal response was observed at the test site of any animal at any time during the 72 hour observation period. Ditetradecyl peroxydicarbonate was classified as non-irritant to the skin.