(E)-4-Ethoxy-1,1,1-trifluoro-3-buten-2-one (stabilized with BHT)

Endpoint summary

Description of key information

Skin irritation/corrosion: ETFBO was demonstrated to be corrosive to skin.

Eye irritation: ETFBO was considered as causing serious eye damage.

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

Study period:

18 Sept.-09 Oct. 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was conducted according to an internationally recognised method, and under GLP. The substance is adequately characterised with its purity. Therefore full validation applies.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate from 2004-08-19

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SPF bred New Zealand White albino rabbits obtained from Centre Lagro, France.
- Sex: Males.
- Age at study initiation: Young adults.
- Weight at study initiation: 1830, 1874 and 1854 g.
- Housing: Individually housed in stainless steel cages with perforated floor.
- Diet: Standard laboratory diet ad libitum. Each batch of this diet was analysed by the supplier (SDS Special Diets services, Whitham, England) for the nutrients and contaminants and the results were kept available in the archives.
- Water: Tap water (N.V. Hydron Midden-Nederland) ad libitum. Results of routine physical, chemical and rnicrobiological examination of drinking water as conducted by the supplier were kept available in the archives.
The results of diet and water analyses were considered acceptable for this study.
- Acclimation period: 5 to 6 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C.
- Humidity: 45 - 72%.
- Air changes: ca 10 air changes per hour.
- Photoperiod: 12 hours light/12 hours dark cycle.

IN-LIFE DATES:
- Start of study: 18/09/2006 (one rabbit) and 19/09/2006 (two rabbits).
- Termination of study: 09/10/2006.

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

Three days prior to the start of the study, the hair was removed from the back and flanks of the animals using electric clippers in a way as to avoid abrasions. The clipping was repeated if considered necessary.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL.
- Concentration (if solution): The test substance is a liquid and was used as it is without dilution.

Duration of treatment / exposure:

Exposure period of ca. 4 hours.

Observation period:

Observation period of 21 days.

Number of animals:

3 rabbits.

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm.
- % coverage: Not clearly reported (an amount of 0.5 mL of the test substance was distributed over a patch measuring 2.5 x 2.5 cm).
- Type of wrap if used: The patch was fixed to the selected application site by means of adhesive tape and the entire trunk of the rabbit was wrapped with an impervious material to maintain the test patch in position.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified.
- Time after start of exposure: After an exposure period of ca. 4 hours the patch and the material applied were removed.

OBSERVATION TIME POINTS
Skin readings were made ca. one hour after the end of exposure and after approximately 24, 48, and 72 h and after 7, 14 and 20/21 days.

SCORING SYSTEM:
- Method of calculation: Draize et al. (J. Pharmacol. Exp. Ther. 82 (1944) 377-390).
A. Erythema and eschar formation
No erythema = 0
Very slight erythema (barely perceptible) = 1
Well-defined erythema = 2
Moderate to severe erythema = 3
Severe erythema (beet redness); eschar formation (injuries in depth: ischemic necrosis, haemorrhages, and incrustation) = 4
B. Oedema formation
No oedema = 0
Very slight oedema (barely perceptible) = 1
Slight oedema (edges of area well-defined by definite raising) = 2
Moderate oedema (raised approximately l millimeter) = 3
Severe oedema (raised more than 1 millimeter, extending beyond the area of exposure) = 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

At 20/21 days after removal, these skin effects had cleared in the three rabbits.

Remarks on result:

other: In combination with slight ischemic necrosis after 24 h and in combination with slight incrustation after 48 and 72 h.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

At 20/21 days after removal, these skin effects had cleared in the three rabbits.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

At 20/21 days after removal, these skin effects had cleared in the three rabbits.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

At 20/21 days after removal, these skin effects had cleared in the three rabbits.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

At 20/21 days after removal, these skin effects had cleared in the three rabbits.

Remarks on result:

other: In combination with slight ischemic necrosis after 24 h and in combination with slight incrustation after 48 and 72 h.

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

At 20/21 days after removal, these skin effects had cleared in the three rabbits.

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

At 20/21 days after removal, these skin effects had cleared in the three rabbits.

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

At 20/21 days after removal, these skin effects had cleared in the three rabbits.

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

At 20/21 days after removal, these skin effects had cleared in the three rabbits.

Remarks on result:

other: In combination with slight ischemic necrosis after 24 h and in combination with slight incrustation after 48 and 72 h.

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

At 20/21 days after removal, these skin effects had cleared in the three rabbits.

Irritation parameter:

edema score

Basis:

animal #3

Time point:

48 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

At 20/21 days after removal, these skin effects had cleared in the three rabbits.

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

At 20/21 days after removal, these skin effects had cleared in the three rabbits.

Irritant / corrosive response data:

At 1 h after removal, well-defined erythema and moderate oedema were observed in the three rabbits.
At 24 h after removal, moderate erythema and moderate oedema were observed in the three rabbits. In addition, slight ischemic necrosis was observed.
At 48 and 72 h after removal, moderate erythema, slight ischemic incrustation and slight or moderate oedema were observed in the three rabbits.
At 7 days after removal, moderate or severe incrustation was observed. In one animal (#2), a few small areas of the incrustation had a black appearance
(haemorrhages). Because of the incrustation present, erythema and oedema could not be scored.
At 14 days after removal, slight, moderate or severe incrustation was observed. Animal #2 still showed the few small black areas. Another animal (#1) showed a few small wounds because of removal of the incrustation by the animal.
At 20/21 days after removal, these skin effects had cleared in the three rabbits, but decreased hair growth (alopecia) was observed on the entire test site of all animals.

Skin irritation scores of ETFBO, after a single 4-hour dermal exposure:

Animal	Hours (h) / days (d) after removal of the test material
	1 h	24 h	48 h	72 h	7 d	14 d	20/21 d
	A-B	A-B	A-B	A-B	A-B	A-B	A-B
#1	2-3	4^1-3	4^2-3	4^2-2	4^3?-?	4^3?-?	0^6-0
#2	2-3	4^1-3	4^2-3	4^2-2	4^4?-?	4^4?-?	0^6-0
#3	2-3	4^1-3	4^2-3	4^2 -2	4^3?-?	4^5?-?	0^6-0

A = erythema (including ischemia, haemorrhages and incrustation); B = oedema

¹= moderate erythema in combination with slight ischemic necrosis (erythema score = 4)

²= moderate erythema in combination with slight incrustation (erythema score = 4)

? = erythema and oedema not discernable because of the incrustation present

³= moderate incrustation (erythema score = 4)

⁴= severe incrustation (erythema score = 4)

⁵= slight incrustation (erythema score = 4)

⁶= decreased hair growth (alopecia)

 

Mean values for erythema and oedema of each rabbit scored at 24, 48 and 72 h after treatment with ETFBO: 

Animal	Erythema	Oedema
#1	4.0	2.7
#2	4.0	2.7
#3	4.0	2.7

 

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

ETFBO was demonstrated to be corrosive to skin.

Executive summary:

The skin corrosion/irritation potential was investigated in a GPL-compliant study performed according to OECD test guideline 404.

The study was carried out with three male New Zealand White albino rabbits. Three days prior to the start of the study, the hair was removed from the back and flanks of the animals using electric clippers in a way as to avoid abrasions. The rabbits were treated as follows: just prior to application, a skin site suitable for application was selected on the clipped flank of the animal. An amount of 0.5 mL of the test substance was distributed over a patch measuring 2.5 x 2.5 cm and fixed to the selected application site by means of adhesive tape. The entire trunk of the rabbit was wrapped with an impervious material to maintain the test patch in position. After an exposure period of ca. 4 hours, the patch and the material applied were removed. Skin readings were made ca. one hour after the end of exposure and after approximately 24, 48, and 72 h and after 7, 14 and 20/21 days using the method of Draize et al. (1944).

At 1 h after removal, well-defined erythema and moderate oedema were observed in the three rabbits. At 24 h after removal, moderate erythema and moderate oedema were observed in the three rabbits. In addition, slight ischemic necrosis was observed. At 48 and 72 h after removal, moderate erythema, slight ischemic incrustation and slight or moderate oedema were observed in the three rabbits. At 7 days after removal, moderate or severe incrustation was observed. In one animal (#2), a few small areas of the incrustation had a black appearance (haemorrhages). Because of the incrustation present, erythema and oedema could not be scored. At 14 days after removal, slight, moderate or severe incrustation was observed. Animal #2 still showed the few small black areas. Another animal (#1) showed a few small wounds because of removal of the incrustation by the animal. At 20/21 days after removal, these skin effects had cleared in the three rabbits, but decreased hair growth (alopecia) was observed on the entire test site of all animals.

According to the GHS criteria, ETFBO has to be considered as corrosive to skin and has to be classified in Category 1 for skin corrosion.

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

Study period:

19 Sept.-03 Oct. 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was conducted according to an internationally recognised method, and under GLP. The substance is adequately characterised with its purity. Therefore full validation applies.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate from 2004-08-19

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: SPF bred New Zealand White albino rabbits obtained from Centre Lagro, France.
- Sex: Males.
- Age at study initiation: Young adults.
- Weight at study initiation: 1856, 1784 and 1790 g.
- Housing: Individually housed in stainless steel cages with perforated floor.
- Diet: Standard laboratory diet ad libitum. Each batch of this diet was analysed by the supplier (SDS Special Diets services, Whitham, England) for the nutrients and contaminants and the results were kept available in the archives.
- Water: Tap water (N.V. Hydron Midden-Nederland) ad libitum. Results of routine physical, chemical and rnicrobiological examination of drinking water as conducted by the supplier were kept available in the archives.
The results of diet and water analyses were considered acceptable for this study.
- Acclimation period: 6 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C.
- Humidity: 40 - 70%.
- Air changes: ca. 10 air changes per hour.
- Photoperiod: 12 hours light/12 hours dark cycle.

IN-LIFE DATES:
- Start of study: 19/09/2006.
- Termination of study: 03/10/2006.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration (if solution): The test substance is a liquid and was used as it is without dilution.

Duration of treatment / exposure:

Single instillation in the conjunctival cul-de-sac of one of the eyes. After administration, the upper and lower eye lids were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye remaining untreated, served as a control.

Observation period (in vivo):

Observation period of 14 days.
The reactions of the test eyes were judged at ca. one, 24, 48, 72 h and at 7 and 14 days after treatment

Number of animals or in vitro replicates:

3 rabbits (first started with one rabbit).

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing and time after start of exposure: Because of the severe ocular discharge observed, the treated eyes were rinsed with physiological saline daily on the first 3 days of the study. This rinsing was performed to avoid complete closure of the eye-lids by the abundant production of colloidal discharge which often forms a sealing crust.

SCORING SYSTEM:
* CORNEA
> Opacity-degree of density (area most dense taken for reading)
- No opacity = 0
- Scattered or diffuse areas, details of iris clearly visible = 1
- Easily discemible translucent area, details of iris slightly obscured = 2
- Opalescent areas, no details of iris visible, size of pupil barely discemible = 3
- Opaque, iris invisible = 4
> Area of comea affected
- One quarter (or less) but no zero = 1
- Greater than one quarter but less than half = 2
- Greater than half, but less than three quarters = 3
- Greater than three quarters, up to whole area = 4
* IRIS
- Normal = 0
- Folds above normal, congestion, swelling, circumcomeal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive) = 1
- No reaction to light, haemorrhage, gross destruction (any or all of these) = 2
* CONJUNCTIVAE
> Redness (refers to palpebral and bulbar conjunctivae, excluding comea and iris)
- Vessels normal = 0
- Vessels definitely injected above normal = 1
- More diffuse, deeper crimson red, individual vessels not easily discemible = 2
- Diffuse beefy red = 3
> Chemosis
- No swelling = 0
- Any swelling above normal (including nictitating membrane) = 1
- Obvious swelling with partial eversion of lids = 2
- Swelling with lids about half closed = 3
- Swelling with lids about half closed to completely closed = 4
* OCULAR DISCHARGE
- No discharge = 0
- Any amount different from normal (does not include amounts observed in inner canthus of normal animals) = 1
- Discharge with moistening of the lids and hairs just adjacent to lids = 2
- Discharge with moistening of the lids and hairs, and cons1derable area around the eye = 3

TOOL USED TO ASSESS SCORE
Not specified.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

other: cornea opacity area

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 d

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 d

Remarks:

Score of 2 after 7 d

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks:

Score of 2 after 7 d

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

48 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks:

Score of 2 after 7 d

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks:

Score of 2 after 7 d

Irritation parameter:

other: ocular discharge

Basis:

animal #1

Time point:

24/48 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

other: ocular discharge

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

other: cornea opacity area

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 d

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 d

Remarks:

Score of 2 after 7 d

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks:

Score of 2 after 7 d

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks:

Score of 2 after 7 d

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks:

Score of 2 after 7 d

Irritation parameter:

other: ocular discharge

Basis:

animal #2

Time point:

24/48 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

other: ocular discharge

Basis:

animal #2

Time point:

72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

other: cornea opacity area

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 d

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 d

Remarks:

Score of 2 after 7 d

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks:

Score of 2 after 7 d

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

48 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks:

Score of 2 after 7 d

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks:

Score of 2 after 7 d

Irritation parameter:

other: ocular discharge

Basis:

animal #3

Time point:

24/48 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

other: ocular discharge

Basis:

animal #3

Time point:

72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

At 1 h after treatment, slight opacity, slight iritis, moderate redness and moderate swelling of the conjunctivae and severe ocular discharge were observed in the rabbits.
At 24, 48 and 72 h after treatment, moderate opacity, slight iritis, severe redness and moderate or severe swelling of the conjunctivae and moderate or severe ocular discharge were observed in the rabbits.
At 7 days after treatment, moderate redness and moderate swelling of the conjunctivae were observed in the three rabbits.
At 14 days after treatment, eye effects had cleared in the rabbits.

Mean values for corneal opacity, iritis, redness and swelling of the conjunctivae of each rabbit scored at 24, 48 and 72 h after treatment with ETFBO:

 

Animal	Corneal opacity	Iritis	Conjunctivae redness	Conjunctivae swelling (chemosis)
#1	2.0	1.0	3.0	2.7
#2	2.0	1.0	3.0	2.3
#3	2.0	1.0	3.0	2.7

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Based on the mean scores following grading at 24, 48 and 72 hours after instillation of the test material and considering full reversibility after 14 days, ETFBO was demonstrated to be irritating to eyes and should be classified in Category 2 for serious eye damage/eye irritation (H319: Causes serious eye irritation). However, applying such a classification would lead to an inconsistency with the labelling resulting from the classification applied for skin corrosion (Category 1, H314: Causes severe skin burns and eye damage). As a matter of consistency at the level of the SDS and the labelling, it was therefore decided to severize the classification for the hazard class serious eye damage/eye irritation and to classify ETFBO in Category 1 (H318: Causes serious eye damage).

Executive summary:

The potential for serious eye damage/eye irritation was investigated in a GPL-compliant study performed according to OECD test guideline 405.

 

The study was carried out with three male New Zealand White albino rabbits. Each rabbit was treated as follows: an amount of ca. 0.1 ml of the test substance was instilled in the conjunctival cul-de-sac of one of the eyes. After administration, the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye remaining untreated, served as a control. The reactions of the test eyes were judged at ca. one, 24, 48, 72 h and at 7 and 14 days after treatment.

 

At 1 h after treatment, slight opacity, slight iritis, moderate redness and moderate swelling of the conjunctivae and severe ocular discharge were observed in the rabbits. At 24, 48 and 72 h after treatment, moderate opacity, slight iritis, severe redness and moderate or severe swelling of the conjunctivae and moderate or severe ocular discharge were observed in the rabbits. In the three rabbits, the mean scores following grading at 24, 48 and 72 h for corneal opacity, iritis, conjunctivae redness and conjunctivae swelling (chemosis) were of 2.0, 1.0, 3.0 and 2.3 - 2.7, respectively. At 7 days after treatment, moderate redness and moderate swelling of the conjunctivae were still observed in the three rabbits. At 14 days after treatment, eye effects had cleared in all the rabbits.

 

According to the GHS criteria and based on the mean scores following grading at 24, 48 and 72 hours after instillation of the test material and considering full reversibility after 14 days, ETFBO was demonstrated to be irritating to eyes and should be classified in Category 2 for serious eye damage/eye irritation (H319: Causes serious eye irritation). However, applying such a classification would lead to an inconsistency with the labelling resulting from the classification applied for skin corrosion (Category 1, H314: Causes severe skin burns and eye damage). As a matter of consistency at the level of the SDS and the labelling, it was therefore decided to severize the classification for the hazard class serious eye damage/eye irritation and to classify ETFBO in Category 1 (H318: Causes serious eye damage).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Additional information

Skin irritation/corrosion: A GPL-compliant study performed according to OECD test guideline 404 is available. It is considered as fully reliable and the result is retained as key data.

Eye irritation: A GPL-compliant study performed according to OECD test guideline 405 is available. It is considered as fully reliable and the result is retained as key data.

Justification for classification or non-classification

Skin irritation/corrosion: According to the GHS criteria, ETFBO has to be considered as corrosive to skin and has to be classified in Category 1 for skin corrosion.

Eye irritation: According to the GHS criteria and based on the mean scores following grading at 24, 48 and 72 hours after instillation of the test material and considering full reversibility after 14 days, ETFBO was demonstrated to be irritating to eyes and should be classified in Category 2 for serious eye damage/eye irritation (H319: Causes serious eye irritation). However, applying such a classification would lead to an inconsistency with the labelling resulting from the classification applied for skin corrosion (Category 1, H314: Causes severe skin burns and eye damage). As a matter of consistency at the level of the SDS and the labelling, it was therefore decided to severize the classification for the hazard class serious eye damage/eye irritation and to classify ETFBO in Category 1 (H318: Causes serious eye damage).