Oligomerisation products of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane with acrylic acid and fatty acids, C18-unsatd., dimers and nonanoic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From August 13, 2012 to August 23, 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Principles of method if other than guideline:

Another guideline was also followed: "Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No. 8147, April 2011; including the most recent partial revisions".

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Oligomerisation products of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane with acrylic acid and fatty acids, C18-unsatd., dimers and nonanoic acid

EC Number:

701-359-2

Cas Number:

216689-76-8

Molecular formula:

Molecular formula not available for this UVCB.

IUPAC Name:

Oligomerisation products of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane with acrylic acid and fatty acids, C18-unsatd., dimers and nonanoic acid

Test material form:

liquid

Specific details on test material used for the study:

Specific Gravity / Density: 1.14 g/cm3; pH (1% in water, indicative range): 5.5 – 5.5 (determined at WIL Research Europe); Stability at higher temperatures: yes, maximum temperature 40°C.

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

male

Details on test animals or test system and environmental conditions:

Animals:
Species: Albino rabbit, New Zealand White, (SPF-Quality). Recognized by international guidelines as the recommended test system (e.g. EC, OECD). Source: Charles River Deutschland, Kisslegg, Germany. Number of animals: 3 Males. Age and body weight: at least 6 weeks old and at least 1.0 kg. Identification: earmark. Health inspection: 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.
Conditions:
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study. Accommodation: animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm). Acclimatization period was at least 5 days before start of treatment under laboratory conditions. Diet: pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) and wooden sticks (Swedish aspen wood, Bioservices, Uden, The Netherlands) were available during the study period. Water: free access to tap water. Diet, water and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of each animal

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4h

Observation period:

1, 24, 48 and 72 hours after exposure

Number of animals:

3

Details on study design:

The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 7 days later, after considering the degree of skin irritation observed in the first animal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

Irritation:
Four hours exposure to 0.5 mL of the test substance resulted in very slight erythema in the treated skin areas of the three rabbits on Day 1. No oedema was noted.
Corrosion:
No evidence of a corrosive effect on the skin.

Other effects:

Coloration / Remnants:
No staining of the treated skin by the test substance was observed. Sticky remnants of the test substance were present on the skin on Day 1 and 2.
Toxicity / Mortality:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

The results were evaluated according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations and the EC criteria for classification and labelling of dangerous substances and preparations (Council Directive 67/548/EEC and all adaptations to technical progress and amendments of this Directive published in the Official Journal of the European Union).

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Remarks:

- does not have to be classified

Executive summary:

A study was conducted to determine the skin irritation/corrosion potential of the test substance according to OECD Guideline 404, EU Method B.4 and EPA OPPTS 870.2500. Three New Zealand White rabbits were exposed to 0.5 ml test substance by application onto clipped skin (150 cm2 area) for 4 h using a semi-occlusive dressing. The untreated skin of each animal served as the reference control. Four hours after application, the dressing was removed and the skin cleaned of residual test substance using tap water. Skin reactions were assessed 1, 24, 48 and 72 h after exposure. Exposure to 0.5 mL of the test substance resulted in very slight erythema in the treated skin areas of the three rabbits on Day 1. No oedema was noted. No corrosive effects on the skin were observed. Under the study conditions, the test substance was considered as not irritating to skin (van Huygevoort, 2012).