5-[(4-carboxybutanoyl)peroxy]-5-oxopentanoic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1993

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

5-[(4-carboxybutanoyl)peroxy]-5-oxopentanoic acid

EC Number:

600-254-8

Cas Number:

10195-54-7

Molecular formula:

C10H14O8

IUPAC Name:

5-[(4-carboxybutanoyl)peroxy]-5-oxopentanoic acid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne
- Age at study initiation: 15 weeks
- Weight at study initiation: 3057 - 3151 g
- Housing: Standard Laboratory Conditions (Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls, with haysticks and wood for gnawing)
- Diet: Pelleted standard Kliba 3410 ("Kliba", Kliba Miihlen AG, 4303 Kaiseraugst, Switzerland) rabbit maintenance diet ad libitum (batch no. 61/98).
- Water: Community tap water from Itingen, ad libitum, in water bowls. Results of analysis are archived by RCC.
- Acclimation period: Four days under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3°C
- Humidity (%): relative humidity 40-70% (values above 70% during cleaning process possible)
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle. Recorded music was played for approximately 8 hours during the light period

IN-LIFE DATES:
Delivery of the animals: 09 June 1998
Acclimatization: 10-14 June 1998
Treatment: 15 June 1998
Observation: 15-30 June 1998
Euthanasia of the animals: 30 June 1998

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5g per animal

VEHICLE
the solid test item was moistened with bidistilled water

Duration of treatment / exposure:

4h

Observation period:

14 days

Number of animals:

3 animals: 2 females, 1 male

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap: surgical gauze and a semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: flushed with lukewarm tap water
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
mortality and clinical signs daily, body weight at start of acclimatization, on the first day of application and at termination of observation

SCORING SYSTEM:
- Method of calculation:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours as well as 7 and 14 days after the removal of the dressing, gauze patch and test article. If evident, corrosive or staining properties of the test article were described and recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Application of the test article to healthy intact rabbit skin resulted in a primary irritation score of 1.33. Local signs (mean values from 24 to 72 hours) consisted of grade 1.33 erythema and grade 0.00 edema. Very slight to well-defined erythema was noted in all animals. This finding was reversible in two animals after 7 days, but persisted in the third animal after 14 days.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. No staining by the test article of the treated skin was observed.
The body weight of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

On the basis of the results obtained in this study according to OECD 404, the test substance does not possess any primary irritating properties to the skin of albino rabbits under the test conditions chosen.

Executive summary:

In this study, the potential irritant and/or corrosive effects of the test substance were evaluated on the skin of New Zealand White rabbits according ot OECD 404. Each of three rabbits received a 0.5g dose of the test article to 6 cm² intact dorsal skin. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours as well as 7 and 14 days after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. The irritation score was calculated per animal at 24, 48 and 72 hours, summed up and then dividing by the number of data points. The irritation score for erythema was 1.33 for all three animals (max. 8.0). This finding was reversible in two animals after 14 days, but persisted in the third animal after 14 days. Local signs (mean values from 24 to 72 hours) consisted also of grade 0.00 edema. The test article did not cause staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. The test article is not considered to be "irritating" to rabbit skin.