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EC number: 701-373-9 | 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
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:
- August 11, 1992 to august 14, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This test was conducted in compliance with EEC Methods, and was performed to comply with GLP regulations.
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Method Directive 84/449/EEC (OJ No. L251, 19.9.84), Part B, Method B.4. Acute toxicity (skin irritation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 10 to 13 weeks
- Weight at study initiation: 2.5-3.5 kg
- Housing: Individually in metal cages with perforated floors.
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet.
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 -1900 hours) in each 24 hours period. - Type of coverage:
- other: Each treatment site was covered with "Elastoplast" elastic adhesive dressing for a four hours period.
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- A 0.5 ml amount of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact skin site on each animal.
- Duration of treatment / exposure:
- The experimental phase of the study was undertaken between 11 and 14 August 1992./Single dermal dose
- Observation period:
- Four hours
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: A 0.5 ml amount of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact skin site on each animal.
- Type of wrap if used: Elastoplast
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with acetone to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: Each treatment site was covered with "Elastoplast" elastic adhesive dressing for a four hours period.
SCORING SYSTEM: Erythema and eschar formation and Oedema formation - Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No dermal response to treatment was observed in any animal throughout the observation period.
- Conclusions:
- Under the study conditions, the test substance was not irritating to rabbit skin.
- Executive summary:
An in vivo skin irritation study was conducted in accordance with Method B.4, Part B, EU DIrective 84/449/EEC, under GLP conditions. Three New zealand white rabbits were exposed to a single semi-occlusive application of 0.5 mL EB 3608 to intact skin for four hours. No dermal response to treatment was observed in any animal up to 72 hours post exposure. Under the study conditions, the test substance was not irritating to rabbit skin (Liggett, 1992).
Reference
Rabbit # | E = ErythemaO = Oedema | Day1, 2, 3, 4 |
579 | EO | 0, 0, 0, 00, 0, 0, 0 |
580 | EO | 0, 0, 0, 00, 0, 0, 0 |
581 | EO | 0, 0, 0, 00, 0, 0, 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From June 02 to 12, 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD guideline 405 with minor deviations: no certificate of analysis
- Justification for type of information:
- Justification for read-across has been mentioned in detail under section 13 of the dataset.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no certificate of analysis
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan France SARL, Gannat, France
- Age at study initiation: 6 weeks (at least)
- Weight at study initiation: 1.0 kg (at least)
- Housing: Housed individually in labelled cages with perforated floors
- Diet (e.g. ad libitum): Pelleted diet (K-H from SSNIFF® Spezialdiaten GmbH, Soest, Germany), 100 g/day; hay (TecniLab-BMI BV, Someren, The Netherlands) provided at least three times a week
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 5 days (at least)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.2-21.5 °C
- Humidity (%): 45-70%
- Air changes (per hour): 15/hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours fluorescent light - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume with unit): 0.1 mL - Duration of treatment / exposure:
- Not aplicable ( eye not rinsed)
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: Not applicable
SCORING SYSTEM: Scoring system same as recommended by OECD Guideline 405
CORNEAL IRRlTATlON
- Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity (may include slight dulling of normal luster): 0
Scattered or diffuse areas of opacity, details of iris clearly visible: 1
Easily discernible translucent area, details of iris slightly obscured: 2
Nacreous area, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4
- Area of cornea involved:
No ulceration or opacity: 0
One quarter or less but not 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
Markedly deepened rugae, congestion, swelling, moderate circumcorneaI hyperaemia, or injection, any of these or combination thereof, iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, hemorrhage, gross destruction (any or all of these): 2
CONJUNCTIVAL IRRlTATlON
- Redness (refers to palpebrae and sclera, excluding cornea and iris):
Blood vessels normal: 0
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson color, individual vessels not easily discernible: 2
Diffuse beefy red: 3
- Chemosis (refers to lids and/or nictitating membranes):
No swelling: 0
Any swelling above normal (includes nictitating membranes): 1
Obvious sweIling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4
- Discharge:
No discharge (may include small amounts observed in inner canthus of normal animals): 0
Any amount different from normal and/or lacrimation: 1
Discharge with moistening of the lids and hairs just adjacent to lids: 2
Discharge with moistening of the lids and hairs (considerable area around the eye): 3
TOOL USED TO ASSESS SCORE: Eye examinations were performed using fluorescein (2%) and/or an ophthalmic examination lamp (if standard lighting was inadequate) - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- - Irritation of the conjunctivae which consisted of redness, chemosis and discharge, completely resolved within 72 hours
- Remnants of the test substance were present and on the outside of the eyelids throughout the observation period
- See table 1 and 2 for further details - Other effects:
- - No mortality or symptoms of systemic toxicity
- Slight bodyweight loss observed in one animal but considered of no toxicological relevance, based on the absence of corroborative findings - Conclusions:
- Under the study conditions, the test substance was not irritating to rabbit eyes.
- Executive summary:
An in vivo eye irritation study was conducted with the read-across substance in rabbits according to the OECD Guideline 405 and in compliance with GLP. Three healthy male New Zealand White rabbits were exposed to 0.1 mL of undiluted test substance to one of the eyes while the other eye corresponded to the control. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 hours after dosing and graded according to the method of OECD Guideline 405. Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation completely resolved within 72 hours. Mean individual scores at 24, 48 and 72 h after exposure for the three animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0.7, 0.7, 0.7 for conjunctivae score and 0, 0, 0 for chemosis score. Under the study conditions, the test substance was not irritating to rabbit eyes (Beerens-Heijnen CGM, 2008).
Reference
Table 1: Individual eye irritation scores
Animal |
Time after dosing (hours) |
Cornea |
Iris |
Conjunctivae |
Comments |
||||
Opacity |
Area |
Fluor area (%)2 |
Redness |
Chemosis |
Discharge |
||||
8471 |
1 |
0 |
0 |
0 |
0 |
2 |
2 |
1 |
c |
24 |
0 |
0 |
0 |
1 |
0 |
1 |
c |
||
48 |
0 |
0 |
0 |
1 |
0 |
0 |
c |
||
72 |
0 |
0 |
0 |
0 |
0 |
0 |
c |
||
859 |
1 |
0 |
0 |
0 |
0 |
2 |
2 |
1 |
c |
24 |
0 |
0 |
0 |
1 |
0 |
1 |
c |
||
48 |
0 |
0 |
0 |
1 |
0 |
0 |
c |
||
72 |
0 |
0 |
0 |
0 |
0 |
0 |
c |
||
861 |
1 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
c |
24 |
0 |
0 |
0 |
1 |
0 |
1 |
c |
||
48 |
0 |
0 |
0 |
1 |
0 |
0 |
c |
||
72 |
0 |
0 |
0 |
0 |
0 |
0 |
c |
1Sentinel
2Green staining after fluorescein treatment (percentage of total corneal area)
c: Remnants of the test substance on the outside of the eyelids
Table 2: Mean (24, 48 and 72 hours) value eye irritation scores
Animal
|
Corneal opacity
|
Iris
|
Conjunctivae |
|
Redness |
Chemosis |
|||
847 |
0 |
0 |
0.7 |
0 |
859 |
0 |
0 |
0.7 |
0 |
861 |
0 |
0 |
0.7 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
An in vivo skin irritation study was conducted in accordance with Method B.4, Part B, EU DIrective 84/449/EEC, under GLP conditions. Three New zealand white rabbits were exposed to a single semi-occlusive application of 0.5 mL of the substance to intact skin for four hours. No dermal response to treatment was observed in any animal up to 72 hours post exposure. Under the study conditions, the test substance was not irritating to rabbit skin (Liggett, 1992).
Eye irritation
An in vivo eye irritation study was conducted with the read-across substance in rabbits according to the OECD Guideline 405 and in compliance with GLP. Three healthy male New Zealand White rabbits were exposed to 0.1 mL of undiluted test substance to one of the eyes while the other eye corresponded to the control. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 hours after dosing and graded according to the method of OECD Guideline 405. Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation completely resolved within 72 hours. Mean individual scores at 24, 48 and 72 h after exposure for the three animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0.7, 0.7, 0.7 for conjunctivae score and 0, 0, 0 for chemosis score. Under the study conditions, the test substance was not irritating to rabbit eyes (Beerens-Heijnen CGM, 2008).
Justification for classification or non-classification
Based on the results of the in vivo skin irritation and eye irritation studies with the test substance and the read-across substance, no classification for skin and eye irritation is warranted according to EU CLP (Regulation EC/1272/2008) criteria.
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