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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethyl-2-oxazoline
EC Number:
233-912-4
EC Name:
2-ethyl-2-oxazoline
Cas Number:
10431-98-8
Molecular formula:
C5H9NO
IUPAC Name:
2-ethyl-2-oxazoline
Test material form:
liquid
Specific details on test material used for the study:
- Name of test item as cited in study report: 2-ethyloxazolin
- Substance number: 81/150

Test animals

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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.