Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 475-900-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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
- 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. - 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.
Reference
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 |
41-3 |
42-3 |
42-2 |
43?-? |
43?-? |
06-0 |
#2 |
2-3 |
41-3 |
42-3 |
42-2 |
44?-? |
44?-? |
06-0 |
#3 |
2-3 |
41-3 |
42-3 |
42 -2 |
43?-? |
45?-? |
06-0 |
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- 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. - 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).
Reference
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 |
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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.