Oxirane, 2-ethyl-, homopolymer, ether with 1,2-ethanediol (2:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4/6/2013-10/6/2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conducted at a GLP accredited laboratory

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oxirane, 2-ethyl-, homopolymer, ether with 1,2-ethanediol (2:1)

IUPAC Name:

Oxirane, 2-ethyl-, homopolymer, ether with 1,2-ethanediol (2:1)

Constituent 2

Reference substance name:

1-[2-(2-hydroxybutoxy)ethoxy]butan-2-ol

EC Number:

695-757-2

Cas Number:

897381-19-0

Molecular formula:

UVCB

IUPAC Name:

1-[2-(2-hydroxybutoxy)ethoxy]butan-2-ol

Details on test material:

Clear light yellow liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The animals were randomly assigned to the study based upon sex, body weight and apparent good health.The rabbits were given the following identification numbers and identified by ear tag numbers 622-624.

Age Range: App. 11 weeks at start of dosing; records of dates of birth for animals used in this study are retained in the Calvert archives.
Body Weight Range: 2.6 to 2. 7 kilograms at the outset (Day 1) of the study.
Animal Source: Millbrook
Experimental History: Purpose-bred and experimentally naive at the outset of the study.
Housing: Animals were individually housed in compliance with USDA Guidelines. The room in which the animals were kept was documented in the study records. No other species were kept in the same room.
Lighting: 12 hours light/12 hours dark
Room Temperature: 17-21 C degrees
Relative Humidity: 43to 78%
Food: All animals had access to PMI Certified Hi-Fiber Rabbit Ojet #5325 as per Calvert SOP. The lot number(s) and specifications of each lot used are archived at Calvert. No contaminants were known to be present in the certified diet at levels that would be expected to interfere with the results of this study. Analysis of the diet was limited to that performed by the manufacturer records of which are maintained in the Calvert archives.
Water: Water was available ad libitum to each animal via an automatic watering device. The water is routinely analyzed for contaminants as per Calvert SOP's. No contaminants were known to be present in the water at levels that would be expected to interfere with the results of this study.
Acclimation: Study animals were acclimated to their housing for a minimum of five days prior to dosing.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

The test article was dosed neat as received directly on intact, delinated skin sites. 0.5 mL of liquid test article was applied to each of the test sites.

Duration of treatment / exposure:

The exposure periods were 3 and 60 minutes and 4 hours, respectively. Following observation of this animal, two rabbits were dosed with the test article with an exposure period of 4 hours.

Observation period:

Observations for dermal irritation were recorded for the initial rabbit immediately after patch removal, at 30-60 minutes and dai1y through Day 4 for the 3 minute and 60 minute exposures. Observations for dermal irritation were recorded for the 4 hour exposure sites at 30-60 minutes post-dose and at 24, 48 and 72 hours. Grading of irritation was according to the method of Draize.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 622M

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: 4h exposure

Results 2

Irritation parameter:

edema score

Basis:

animal: 622M

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: 4h exposure

Results 3

Irritation parameter:

erythema score

Basis:

animal: 623M

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: 4h exposure

Results 4

Irritation parameter:

edema score

Basis:

animal: 623M

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: 4H exposure

Results 5

Irritation parameter:

erythema score

Basis:

animal: 624M

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: 4h exposure

Results 6

Irritation parameter:

edema score

Basis:

animal: 624M

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: 4h exposure

Results 7

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 60 min

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: very slight erythema of one animal on Day 2, resolving by Day 3

Irritant / corrosive response data:

The most severe dermal responses observed were very slight erythema of one animal on Day 2, resolving by Day 3 after 60 mins exposure.

Other effects:

No mortality was observed during the study. No clinical signs were recorded during the course of the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Precursor PO 206 was found to be non-irritating according to the EEC Irritation Rating and the GHS Classification. The Primary Irritation Index was 0.0.

Executive summary:

The purpose of this study was to determine the potential irritant and/or corrosive effects of the test article on the skin of rabbits. Precursor PO 206 was administered dermally to three New Zealand White rabbits at 0.5 mL per site. The exposure periods were 3 and 60 minutes and/or 4 hours, respectively.

The most severe dermal responses observed were very slight erythema of one animal on Day 2, resolving by Day 3 after 60 mins exposure. PO 206 was found to be non-irritating according to the EEC Irritation Rating and the GHS Classification. The Primary Irritation Index was 0.0.