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

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3/07/2013-12/07/2013

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 406 (Skin Sensitisation)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

The study has been performed according to a scientifically and regulatorily valid OECD TG at the time of the performance of the study.

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:

Light yellow liquid. It stored at room temprature in dark.

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

male/female

Details on test animals and environmental conditions:

Age: 4 weeks
BW: 328-337 gr (dose range), 313-442 g (main 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: 16-27 C degrees
Relative Humidity: 25to 96%
Food: All animals had access to HArlan Tekland Guinea Pig Diet ad libitum. 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 5-7 days prior to dosing.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: Dermal induction with patch

Vehicle:

physiological saline

Induction 2

Concentration / amount:

Initially, a dose range was performed in four na'ive animals with the test article, PD 206, at 5%, 25%, 50% and 100% (as received). Based on these results, an induction dose and challenge dose of 100% (as received) was chosen for this study.

Challenge

Challenge 1

Route:

other: Dermal induction with patch

Vehicle:

physiological saline

Challenge 2

Concentration / amount:

Initially, a dose range was performed in four na'ive animals with the test article, PD 206, at 5%, 25%, 50% and 100% (as received). Based on these results, an induction dose and challenge dose of 100% (as received) was chosen for this study.

No. of animals per dose:

Four primary irritation
Twenty test article group (10/sex)
Ten vehicle control (5/sex)
Six positive control (3/sex)

Details on study design:

Article group were induced with two six-hour occluded dermal applications of PD 206 (as received) (second and third inductions). For the first induction, it is documented that the dental dam and patch were removed ~4 hours after test article application . A vehicle group of ten animals (5/sex) was induced in the same manner with 0.9% saline.
Fifteen days after the last induction, all animals were dermally challenged with occluded applications at naiive test sites. Animals in the test article and vehicle control group were challenged with PD 206 (as received) and 0.9% saline. Animals in the positive control group were challenged with DNCB (0.2°.4> in acetone). On the day following the challenge, animals were depilated and approximately three hours later were scored for dermal irritation (24 hour). Scoring was repeated at 48 hours.

Challenge controls:

A positive control group of six animals (3/sex) was induced with a known dermal sensitizer: 1-chloro-2,4-dinitrobenzene (DNCB).

Positive control substance(s):

yes

Remarks:

1-chloro-2,4-dinitrobenzene (DNCB)

Results and discussion

Positive control results:

The positive control group, induced and challenged with DNCB, exhibited the anticipated positive responses at challenge indicating that the methods
employed in this study were valid. All dermal irritation scores at the 24- and 48-hour observations were zero for the vehicle control animals challenged with the test article and the vehicle (saline).

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100% and in saline

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

incidence and severity

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

100% and in saline

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

incidence and severity

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

0.2% DNCB

No. with + reactions:

6

Total no. in group:

6

Clinical observations:

incidence and severity

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

positive control

Dose level:

0.2% DNCB

No. with + reactions:

6

Total no. in group:

6

Clinical observations:

incidence and severity

Any other information on results incl. tables

All dermal irritation scores at the 24- and 48-hour observations were zero for the test article group animals challenged with the test article and the vehicle (saline).

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study induction with Precursor PD 206 did not elicit a delayed contact hypersensitivity response in guinea pigs when challenged.

Executive summary:

The purpose of this study was to determine if a test article elicits a delayed dermal contact hypersensitivity response in guinea pigs by the measurement of skin reactivity.

The positive control group, induced and challenged with DNCB, exhibited the anticipated positive responses at challenge indicating that the methods employed in this study were valid. Under the conditions of this study induction with Precursor PD 206 did not elicit a delayed contact hypersensitivity response in guinea pigs when challenged.