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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 3 min
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 11 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 4 h
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 11 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 4 h
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 4 h
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 4 h
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 4 h
Score:
>= 0 - <= 4
Max. score:
4
Reversibility:
fully reversible within: 5 days
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.