Registration Dossier

Diss Factsheets

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.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Categories Display