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EC number: 482-670-8 | 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: not irritating
- Eye irritation: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1 September 2006 to 20 April 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: the study was performed according to internationally recognised guidelines and GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- the temperature and relative humidity sometimes outside of the target ranges (this minor deviation was not considered to have compromised the validity or integrity of the study).
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see higher
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- see higher
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Grimaud frères selection S.A.S., La Corbière, Roussay, France
- Age at study initiation: on the day of treatment, the animals were 2 to 4 months old
- Weight at study initiation: on the day of treatment, the animals had a mean body weight of 2.8 ± 0.2 kg
- Housing: the animals were housed individually in Pajon cages (50 cm x 57 cm x 75 cm)
- Diet: free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France)
- Water: drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: 30 to 70%
- Air changes: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: from 12 September 2006 (day of treatment of the first animal) to 17 September 2006 (end of the observation period) - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 mg - Duration of treatment / exposure:
- The test item was first evaluated on a single animal. The durations of exposure were 3 minutes, 1 hour and 4 hours.
Since the test item was neither severely irritant nor corrosive on this first animal, it was then applied for 4 hours simultaneously to two other animals. - Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: anterior left flank (application for 3 minutes), anterior right flank (application for 1 hour) or posterior right flank (application for 4 hours)
- % coverage: approximately 6 cm2
- Type of wrap if used: gauze pad held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage
REMOVAL OF TEST SUBSTANCE
- Washing: yes (any residual test item was wiped off by means of a dry cotton pad
- Time after start of exposure: 4 hours
SCORING SYSTEM:
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) to slight eschar formation (injuries in depth) -> 4
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 1 millimetre) -> 3
. severe oedema (raised more than 1 millimetre and extending beyond area of exposure) -> 4 - Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: NOt applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- After a 3-minute and a 1-hour exposure (one animal):
No cutaneous reactions were observed.
After a 4-hour exposure (three animals):
A very slight erythema (grade 1) was noted in 2/3 animals on day 1 only.
No other cutaneous reactions were observed thereafter.
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Neodymium tris(di-2-ethylhexylphosphate) is not considered to be a skin irritant in the rabbit.
- Executive summary:
In a primary dermal irritation study performed according to OECD 404, EC B.4, US/EPA/OPPTS 870.2500 and GLP (CIT report No. 32230 TAL, 2007), scored as validity 1 according to Klimisch criteria, 3 male New Zealand White rabbits were dermally exposed to 0.5 g of neodymium tris(di-2-ethylhexylphosphate) applied on the skin of flanks and maintained under semi-occlusive dressing for 4 hours. Animals then were observed for 72 hours. Irritation was scored 1, 24, 48 and 72 h after removal of the dressing by calculating dermal irritation scores, based on the grading of cutaneous erythema and edema.
After a 3-minute and a 1-hour exposures (one animal), no cutaneous reactions were observed.
After a 4-hour exposure (three animals), a very slight erythema was noted in 2/3 animals on day 1 only. No other cutaneous reactions were observed thereafter.
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema.
The test substance was considered as non-irritant to the skin. No classification for skin irritation is warranted based on the observed cutaneous reactions following a 4-hour exposure, according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.
This study is classified as acceptable. It satisfies international guideline requirements for acute dermal irritation or corrosion.
Referenceopen allclose all
Table 1: Individual cutaneous examinations and mean values of the scores recorded for each animal (24, 48 and 72 hours)
Rabbit number |
Dermal irritation |
Scores |
Mean irritation score (1) |
Interpretation (+) or (-) |
|||
1h |
24h |
48h |
72h |
||||
646 |
Erythema Edema Other |
0 0 * |
0 0 * |
0 0 * |
0 0 * |
0.0 0.0 |
(-) (-) |
608 |
Erythema Edema Other |
1 0 * |
0 0 * |
0 0 * |
0 0 * |
0.0 0.0 |
(-) (-) |
609 |
Erythema Edema Other |
1 0 * |
0 0 * |
0 0 * |
0 0 * |
0.0 0.0 |
(-) (-) |
(1) mean of scores on days 2, 3 and 4
(+) = irritant according to E.E.C. criteria
(-) = non-irritant according to E.E.C. criteria
* = none
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1 September 2006 to 20 April 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: the study was performed according to internationally recognised guidelines and GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- the temperature and relative humidity sometimes outside of the target ranges (this minor deviation was not considered to have compromised the validity or integrity of the study)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see higher
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- see higher
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Grimaud frères selection S.A.S., La Corbière, Roussay, France
- Age at study initiation: on the day of treatment, the animals were 2 to 4 months old
- Weight at study initiation: on the day of treatment, the animals had a mean body weight of 3.0 ± 0.2 kg
- Housing: individually in Pajon cages (50 cm x 57 cm x 75 cm)
- Diet: free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France)
- Water: drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: 30 to 70%
- Air changes: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12hrs dark / 12hrs light)
IN-LIFE DATES: from 19 September 2006 (day of treatment of the first animal) to 24 September 2006 (end of the observation period) - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount: 100 mg
- Concentration: undiluted - Duration of treatment / exposure:
- Single conjunctival instillation
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM:
Ocular reactions were scored according to the following numerical scale:
CONJUNCTIVAL LESIONS AND DISCHARGE:
> Chemosis (lids and/or nictitating membranes)
. no swelling = 0
. any swelling above normal (includes nictitating membranes) = 1
. obvious swelling with partial eversion of lids = 2
. swelling with lids about half-closed = 3
. swelling with lids more than half-closed = 4
> Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
. blood vessels normal = 0
. a number of blood vessels definitely hyperemic (injected) = 1
. diffuse, crimson colour, individual vessels not easily discernible = 2
. diffuse, beefy red = 3
> Discharge
. absence of discharge = 0
. slight discharge (does not include small amounts normally found in inner canthus) = 1
. discharge with moistening of lids and hairs adjacent to lids = 2
. discharge with moistening of lids and hairs on wide area around the eye = 3
IRIS LESIONS:
. normal = 0
. markedly deepened rugae, congestion, swelling, moderate circum-corneal hyperemia, or injection, any 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
CORNEAL LESIONS:
> Degree of opacity (area most dense taken for reading)
. no ulceration or opacity = 0
. scattered or diffuse areas of opacity (other than slight dulling or normal lustre), details of iris clearly visible = 1
. easily discernible translucent area, details of iris slightly obscured = 2
. nacreous areas, no details of iris visible, size of pupil barely discernible = 3
. opaque cornea, iris not discernible through the opacity = 4
> Area of opacity
. one quarter (or less) but not zero = 1
. greater than one quarter but less than a half = 2
. greater than one half but less than three quarters = 3
. greater than three quarters up to whole area = 4
Any other lesions observed were noted.
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicale
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- A slight chemosis (grade 1) was observed in all the animals on days 1.
A slight redness of the conjunctiva (grade 1) was noted in all the animals at 1 hours after treatment; it persisted at time point 24 hours in 2/3 animals.
No other ocular reactions were recorded during the study. - Other effects:
- Residual test item was noted in all the animals on day 1 only.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Neodymium tris(di-2-ethylhexylphosphate) is not considered to be an eye irritant in the rabbit according to EU criteria.
- Executive summary:
In a primary eye irritation study performed according to OECD 405, EC B.5 ,US/EPA/OPPTS 870.2400 and GLP (CIT report No.32231 TAL, 2007), scored as validity 1 according to Klimisch criteria, 100 mg of neodymium tris(di-2-ethylhexylphosphate) were instilled into the conjunctival sac of the left eye of 3 male New Zealand White rabbits. Exposed eyes were not rinsed. Animals then were observed for 72 hours. Irritation was scored 1, 24, 48 and 72 hours after instillation by calculating ocular irritation scores, based on the grading of conjunctiva, iris and cornea scores.
A slight chemosis was observed in all the animals on days 1, from 1 hour up to 24 hours after treatemnt.
A slight redness of the conjunctiva was noted in all the animals 1h after treatement; it persisted up to 24 hours in 2/3 animals.
Residual test item was noted in all the animals on day 1 only.
No other ocular reactions were recorded during the study.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.3, 0.3 and 0.3 for chemosis, 0.0, 0.3 and 0.3 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.
No classification for eye irritation is warranted based on the ocular reactions observed during 72 hours after exposure, according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.
This study is classified as acceptable. It satisfies the international guideline requirements for acute eye irritation or corrosion.
Referenceopen allclose all
Table 1: Individual ocular examinations and mean values of the scores recorded for each animal (24, 48 and 72 hours)
Rabbit number |
Region of the eye |
Description of ocular reactions |
Scores |
Mean irritation score (1) |
Interpretation (+) or (-) |
|||
1h |
24h |
48h |
72h |
|||||
646 |
Conjunctivae |
Chemosis Redness Discharge |
1 1 0 |
1 0 0 |
0 0 0 |
0 0 0 |
0.3 0.0 0.0 |
(-) (-) |
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
(-) |
|
Corneal opacity |
Intensity Area |
0 0 |
0 0 |
0 0 |
0 0 |
0.0 0.0 |
(-) |
|
Other |
|
Su |
* |
* |
* |
|
|
|
Fluorescein |
|
/ |
U |
/ |
/ |
|
|
|
608 |
Conjunctivae |
Chemosis Redness Discharge |
1 1 0 |
1 1 0 |
0 0 0 |
0 0 0 |
0.3 0.3 |
(-) (-) |
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
(-) |
|
Corneal opacity |
Intensity Area |
0 0 |
0 0 |
0 0 |
0 0 |
0.0 0.0 |
(-) |
|
Other |
|
Su |
* |
* |
* |
|
|
|
Fluorescein |
|
/ |
U |
/ |
/ |
|
|
|
609 |
Conjunctivae |
Chemosis Redness Discharge |
1 1 0 |
1 1 0 |
0 0 0 |
0 0 0 |
0.3 0.3 |
(-) (-) |
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
(-) |
|
Corneal opacity |
Intensity Area |
0 0 |
0 0 |
0 0 |
0 0 |
0.0 0.0 |
(-) |
|
Other |
|
Su |
* |
* |
* |
|
|
|
Fluorescein |
|
/ |
U |
/ |
/ |
|
|
(1) mean of scores on days 2, 3 and 4
(+) = irritant according to E.E.C. criteria
(-) = non-irritant according to E.E.C. criteria
* = none
Su = residual test item
U = fluorescein batch No. K 742
/ = fluorescein not used
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Neodymium tris(di-2-ethylhexylphosphate) was tested in one dermal irritation study and one eye irritation study, both performed according to internationally recognised guidelines and GLP, scored as validity 1 according to Klimisch criteria, and considered as key studies acceptable for the assessment.
In a primary dermal irritation study performed according to OECD 404, EC B.4, US/EPA/OPPTS 870.2500 and GLP (CIT report No. 32230 TAL, 2007), scored as validity 1 according to Klimisch criteria, 3 male New Zealand White rabbits were dermally exposed to 0.5 g of neodymium tris(di-2-ethylhexylphosphate) applied on the skin of flanks and maintained under semi-occlusive dressing for 4 hours. Animals then were observed for 72 hours. Irritation was scored 1, 24, 48 and 72 h after removal of the dressing by calculating dermal irritation scores, based on the grading of cutaneous erythema and edema.
After a 3-minute and a 1-hour exposures (one animal), no cutaneous reactions were observed.
After a 4-hour exposure (three animals), a very slight erythema was noted in 2/3 animals on day 1 only. No other cutaneous reactions were observed thereafter.
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema.
According to these results, the test item is not classified as a skin irritant according to EU criteria.
In a primary eye irritation study performed according to OECD 405, EC B.5, US/EPA/OPPTS 870.2400 and GLP (CIT report No.32231 TAL, 2007), scored as validity 1 according to Klimisch criteria, 100 mg of neodymium tris(di-2-ethylhexylphosphate) were instilled into the conjunctival sac of the left eye of 3 male New Zealand White rabbits. Exposed eyes were not rinsed. Animals then were observed for 72 hours. Irritation was scored 1, 24, 48 and 72 hours after instillation by calculating ocular irritation scores, based on the grading of conjunctiva, iris and cornea scores.
A slight chemosis was observed in all the animals on days 1 and 2.
A slight redness of the conjunctiva was noted in all the animals on day 1; it persisted on day 2 in 2/3 animals.
Residual test item was noted in all the animals on day 1 only.
No other ocular reactions were recorded during the study.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.3, 0.3 and 0.3 for chemosis, 0.0, 0.3 and 0.3 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.
According to these results, the test item is not classified as an eye irritant according to EU criteria.
Justification for classification or non-classification
Based on the results of these studies, neodymium tris(di-2-ethylhexylphosphate) was considered as non-irritant to the skin and to the eye. No classification for skin and eye irritation is warranted, according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.
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