methylethylketone peroxide trimer

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well conducted GLP study. No certificate of analysis included in the report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-320-2

EC Name:

-

Cas Number:

24748-23-0

Molecular formula:

C12H24O6

IUPAC Name:

3,6,9-triethyl-3,6,9-trimethyl-1,2,4,5,7,8-hexaoxonane

Constituent 2

Reference substance name:

Initiator D-129

IUPAC Name:

Initiator D-129

Details on test material:

Colourless liquid
Batch No.: KOW96170
44% in aliphatic hydrocarbons

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Albino Rabbit, New Zealand White, (SPF-Quality)
Source: Broekman Institute, Someren, The Netherlands.


Air-conditioned room with approximately 15 air changes per hour and the
environment controlled with optimal conditions considered as being a temperature
of 21°C and a relative humidity of 50%. Fluctuations from these optimal
conditions were noted, but were considered not to have affected study integrity.
Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.

Accommodation
Individually in labelled cages with perforated floors (Scanbur Denmark) and
equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
Acclimatisation period was at least 5 days before start of treatment under
laboratory conditions.

Diet
Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms,
Woerden, The Netherlands) approx. 100 gram per day. Certificates of analysis
were examined and retained in the NOTDX archives.
In addition, hay (BMI, Helmond, The Netherlands) was provided once a week.

Water
Free access to tap-water diluted with decalcified water.
Certificates of quarterly analysis were examined and retained in the NDTDX
archives.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Details on study design:

Approximately 24 hours before treatment, the dorsal fur was clipped with
electric clippers, exposing an area of approximately 150 square centimeters
(10x15 cm').
A health inspection was performed prior to the commencement of treatment, to
ensure that the animals were in a good state of health. Special attention was
paid to the skin to be treated, which was intact and free from abnormalities.
On test day 1, 0.5 ml of the test substance was applied to the skin of one
flank, using a surgical gauze patch of 2x3 cm. The patch was mounted on
Micropore tape*. which was wrapped around the abdomen and secured with Coban
elastic bandage.
Four hours after the application, the dressing was removed and the remaining
test substance removed using a tissue moistened with tap-water and subsequently
a dry tissue.
Whenever considered necessary the treated skin areas were re-clipped at least 3
hours before the observations, to facilitate the scoring .

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

3.7

Max. score:

2.3

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

labelling requirements for dangerous substances and preparations (Guidelines in
Commission Directive 93/21/EEC, 27th April 1993), the test substance should be labelled as:
irritating to the skin (R 38).

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Based on these results and according to the EEC criteria For classification and
labelling requirements For dangerous substances and preparations (Guidelines in
Commission Directive 93/21/EEC, 27th April 1993), 0-129 should be labelled as:
irritating to the skin (R 38).
-

Executive summary:

The study was carried out in accordance with the OECD guideline No. 404, 'Acute Dermal Irritation/Corrosion' and the EEC Directive 92/69/EEC, B.4, 'Acute Toxicity - Skin irritation. Three rabbits were exposed to 0.5 m1 of the test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours, 7 and 14 days after exposure. Exposure to the test substance resulted in well defined or moderate to severe erythema and slight oedema in the treated skin-areas of the three rabbits. Scaliness was observed in all animals 7 days after exposure. The skin irritation had resolved within 14 days after exposure in all animals. Sticky remnants of the test substance, which became dry remnants after day 1, were present in the treated skin-areas of all animals up to 72 hours after exposure. Dermal application of the test substance resulted in a primary irritation index of 3.7 (moderately irritating) when applied to the intact rabbit skin. Based on these results and according to the EEC criteria For classification and labelling requirements For dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC, 27th April 1993), the test substance should be labelled as: irritating to the skin (R 38).

The test substance would be classified as a category 2 irritant in accordance with the criteria for classification in accordance with Guidance to Regulation (EC) No 1272/2008 on classifica tion, labelling and packaging (CLP) of substances and mixtures Version 3.0 November 2012.