2-ethyl-2-oxazoline

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Remarks:

in vivo skin corrosion study

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test item as cited in study report: 2-ethyloxazolin
- Substance number: 81/150

Species:

rabbit

Strain:

other: Weisser wiener

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma gaukler 6050 offenbach/Main
- Weights: 2.77 kg for the male, 3.10 kg for the female
- housing: housed singly in cages; stainless steel with wire inlaid floor (dimensions: 40 cm x 51 cm)
- diet: provided with ca. 130 g of feed and with 250 mL of drinking water daily

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 26 °C
- Relative humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Type of coverage:

occlusive

Preparation of test site:

shaved

Remarks:

at least 15 hr before the start of the trial

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

- two treatments: 3 min, 1 hr

Observation period:

30 - 60 minutes following treatment then after 24 hrs, 48 hrs, and 8 days

Number of animals:

2 (1 male and 1 female)

Details on study design:

TEST SITE
- Area of exposure: upper third of the back or flank region
- % coverage: 2.5 cm x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the end of the exposure period, washed with Lutrol and Lutrol/Water (1:1)


OBSERVATION TIME POINTS
- 30 - 60 minutes following treatment then after 24 hrs, 48 hrs, and 8 days

SCORING SYSTEM:
- according to Draize, 1959

Irritation parameter:

erythema score

Remarks:

3 min exposure

Basis:

animal #1

Remarks:

female

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 8 d

Irritation parameter:

erythema score

Remarks:

3 min exposure

Basis:

animal #2

Remarks:

male

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 8 d

Irritation parameter:

edema score

Remarks:

3 min exposure

Basis:

animal #1

Remarks:

female

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: No effect observed

Irritation parameter:

edema score

Remarks:

3 min exposure

Basis:

animal #2

Remarks:

male

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: no effect observed

Irritation parameter:

erythema score

Remarks:

3 min exposure

Basis:

animal #1

Remarks:

female

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 8 d

Irritation parameter:

erythema score

Remarks:

3 min exposure

Basis:

animal #2

Remarks:

male

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 8 d

Irritation parameter:

edema score

Remarks:

3 min exposure

Basis:

animal #1

Remarks:

female

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: no effect observed

Irritation parameter:

edema score

Remarks:

3 min exposure

Basis:

animal #2

Remarks:

male

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: no effect observed

Irritation parameter:

erythema score

Remarks:

3 min exposure

Basis:

animal #1

Remarks:

female

Time point:

other: 8 d

Score:

0

Max. score:

0

Reversibility:

other: no effect observed

Irritation parameter:

erythema score

Remarks:

3 min exposure

Basis:

animal #2

Remarks:

male

Time point:

other: 8 d

Score:

0

Max. score:

0

Reversibility:

other: no effect observed

Irritation parameter:

edema score

Remarks:

3 min exposure

Basis:

animal #1

Remarks:

female

Time point:

other: 8 d

Score:

0

Max. score:

0

Reversibility:

other: no effect observed

Irritation parameter:

edema score

Remarks:

3 min exposure

Basis:

animal #2

Remarks:

male

Time point:

other: 8 d

Score:

0

Max. score:

0

Reversibility:

other: no effect observed

Irritation parameter:

erythema score

Remarks:

1 hr exposure

Basis:

animal #1

Remarks:

female

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

erythema score

Remarks:

1 hr exposure

Basis:

animal #2

Remarks:

male

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

edema score

Remarks:

1 hr exposure

Basis:

animal #1

Remarks:

female

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

edema score

Remarks:

1 hr exposure

Basis:

animal #2

Remarks:

male

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

erythema score

Remarks:

1 hr exposure

Basis:

animal #1

Remarks:

female

Time point:

48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

erythema score

Remarks:

1 hr exposure

Basis:

animal #2

Remarks:

male

Time point:

48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

edema score

Remarks:

1 hr exposure

Basis:

animal #1

Remarks:

female

Time point:

48 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

edema score

Remarks:

1 hr exposure

Basis:

animal #2

Remarks:

male

Time point:

48 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

erythema score

Remarks:

1 hr exposure

Basis:

animal #1

Remarks:

female

Time point:

other: 8 d

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

erythema score

Remarks:

1 hr exposure

Basis:

animal #2

Remarks:

male

Time point:

other: 8 d

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

edema score

Remarks:

1 hr exposure

Basis:

animal #1

Remarks:

female

Time point:

other: 8 d

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

edema score

Remarks:

1 hr exposure

Basis:

animal #2

Remarks:

male

Time point:

other: 8 d

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

erythema score

Remarks:

both 3 min & 1 hour exposure

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

edema score

Remarks:

3 min & 1 hour exposure

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

The shaved upper third of the back or flank region of two rabbits (1 male and 1 female) were treated with 0.5 mL of ETOX for 3 min and for 1 hr and then observed at 30 - 60 minutes following treatment then after 24 hrs, 48 hrs, and 8 days. The effects were scored using the Draize system. Following the 3 min exposure period, slight (very weak) erythema was noted for the first 48 hrs in both rabbits. However, the effects were reversible by 8 days. No edema was noted in either rabbit following the 3 min exposure period.Following the 1 hr exposure period, strong to very strong irreversible erythema and edema was noted in both rabbits. Profound necrosis was reported by day 8.