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Description of key information

Skin irritation/corrosion

In a key study, 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.

Eye irritation

In a key study, the eyes of six rabbits (3 males and 3 females) were instilled with 0.1 mL of ETOX and then observed at 1, 24, 48, 72 hours then again at 8 and 14 days following application. Only one eye was treated and the other eye was left untreated as a negative control. Average overall irritation scores at 24, 48, 72 hrs and at 8 and 14 days were 37, 37, 36, 39, and 37 respectively. The results were not fully reversed by the end of the 14 day study period.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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 405 (Acute Eye 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 tissues and environmental conditions:
TEST ANIMALS
- Source: Firma gaukler 6050 offenbach/Main
- mean weights: 2.64 kg for males, 2.73 kg for females
- housing: housed singly in cages; stainless steel with wire inlaid floor (dimensions: 40 cm x 51 cm)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 26 °C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
- at 1, 24, 48, 72 hours and 8 and 14 days post treatment
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
- instilled into conjuctiva of right eye
- effects scored using Draize (1959) rating system
- test item is not washed out
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Remarks:
fully reversed in 2/6 animals
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Remarks:
fully reversed in 2/6 animals
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
37
Max. score:
37
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Remarks:
fully reversed in 2/6 animals
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
37
Max. score:
39
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Remarks:
fully reversed in 2/6 animals
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
36
Max. score:
39
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
other: 8 d
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks:
fully reversed in 2/6 animals
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
other: 8 d
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
other: 8 d
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
other: 8 d
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 animals
Time point:
other: 8 d
Score:
39.3
Max. score:
57
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks:
fully reversed in 2/6 animals
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
37
Max. score:
73
Reversibility:
not reversible
Irritant / corrosive response data:
Irritation to the cornea, the iris, and conjunctiva were scored using the Draize system.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The eyes of six rabbits (3 males and 3 females) were instilled with 0.1 mL of ETOX and then observed at 1, 24, 48, 72 hours then again at 8 and 14 days following application. Only one eye was treated and the other eye was left untreated as a negative control. Average overall irritation scores at 24, 48, 72 hrs and at 8 and 14 days were 37, 37, 36, 39, and 37 respectively. The results were not fully reversed by the end of the 14 day study period.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Additional information

Justification for classification or non-classification

Skin corrosion/irritation

A preliminary study identified ETOX as skin corrosive. A subsequent study determined the severity of the corrosive effect. Rabbits exposed to ETOX for 3 minutes did not report irreversible effects. Rabbits exposed to ETOX for 1 hour did report visible necrosis that was not reversible. Therefore, according to CLP EC 1272/2008, ETOX is classified as Skin Corrosive Category 1B.

 

Serious eye damage/eye irritation

As ETOX is classified as Skin Corrosive Category 1B, by default it is also classified as Eye Damage Category 1. Additionally, an eye irritation study demonstrated that ETOX produced irreversible effects on the eye.

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