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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-138-7 | CAS number: 10043-27-3
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Final report: 04-APR-1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No certificate of analysis for the test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Draize method
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 4 animals, observation period of 7 days
- GLP compliance:
- no
Test material
- Reference substance name:
- Terbium trinitrate
- EC Number:
- 233-138-7
- EC Name:
- Terbium trinitrate
- Cas Number:
- 10043-27-3
- Molecular formula:
- HNO3.1/3Tb
- IUPAC Name:
- terbium trinitrate
- Test material form:
- other: colourless liquid
- Details on test material:
- - Name of test material (as cited in study report): Nitrate de terbium
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 kg to 3 kg
IN-LIFE DATES: From: 10-MAR-1980 To: 01-APR-1980
No other information were available.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- other: The right eye, which remained untreated, served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL introduced into the conjunctival sac of the left eye - Duration of treatment / exposure:
- Single conjunctival instillation
- Observation period (in vivo):
- 1 hour, 1, 2, 3, 4 and 7 days after instillation
- Number of animals or in vitro replicates:
- 4 rabbits per treatment group
- Details on study design:
- TREATMENT PROCEDURE
0.1 mL of test item as such was placd into the conunctival sac of the left eye of each animal.
REMOVAL OF TEST SUBSTANCE
- Washing: one treatment group without washing and one treatment group with washing 30 seconds after instillation
SCORING SYSTEM:
- Cornea opacity: degree of density (area most dense taken for reading)
No ulceration or opacity = 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible = 1
Easily discernible translucent areas, 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
- Iris
Normal = 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia 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
- Conjunctivae
* Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
Blood vessels normal = 0
Some blood vessels definitely hyperaemic (injected) = 1
Diffuse, crimsom colour, individual vessels not easily discernible = 2
Diffuse beefy red = 3
* Chemosis (lids and/or nictating membranes)
No swelling = 0
Any swelling above normal (includes ncitating 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
The coefficients of the conjunctival damage, the iris damage and the corneal damage allow to determine 3 indices of ocular irritation:
- the individual eye irritation index (= IEI), the maximum value of which equals 110, is equal to each time, for each rabbit, to 2 (A + B + C) + 5A1 + 5A2B2
- the mean ocular irritation index (= MOI) is the average, at each time, of the IEI of the 4 treated rabbits;
- the acute eye irritation index (= AEI) is the highest MOI obtained within 7 days of observation.
The interpretation of the results is made from these 3 index and is drawn from KAY and CALANDRA (J. Soc. Cosmet. Chem., 13, 281 (1962): "Interpretation of eye-irritation tests").
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Presence of a membrane on half of the corneal surface at 24 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: Circumcorneal injections + congestion of the iris
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Presence of a whitish humor on the edge of the eyelids at 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: At 24 and 48 hours, impossible read due to corneal opacification. At 72 hours, circumcorneal injections + congestion of the iris (score = 1)
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Presence of a whitish humor on the edge of the eyelids at 24 and 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: Circumcorneal injections + congestion of the iris
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Presence of a whitish humor on the edge of the eyelids at 24 and 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Presence of a membrane on half of the corneal surface at 24 hours
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- other: impossible read due to corneal opacification
- Remarks on result:
- other: At 24 and 48 hours, Circumcorneal injections + congestion of the iris. At 72 hours, impossible read due to corneal opacification
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Presence of a whitish humor on the edge of the eyelids at 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: mean score 24, 48 and 72 hours
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Chemosis (grade 4), enanthema (score 1 - 3), congestion of iris (score 1 - 2) and corneal opacity (score 2 - 4) were observed in all animals at 1h and remained present at the end of the observation study (day 7).
Any other information on results incl. tables
Table 1 : Results (without rinsing)
Evaluation of effects |
1 hour |
D1 |
D2 |
|||||||||||
N° of rabbits |
147 |
148 |
149 |
150 |
147 |
148 |
149 |
150 |
147 |
148 |
149 |
150 |
||
Conjunctiva |
A) Chemosis 0 - 4 |
4 |
4 |
4 |
4 |
4£ |
4£ |
4£ |
4£ |
4 |
4£ |
4£ |
4 |
|
B) Discharge 0 - 3 |
1 |
1 |
1 |
1 |
2 |
2 |
3 |
2 |
3 |
3 |
3 |
3 |
||
C) Enanthema 0 - 3 |
1 |
1 |
1 |
1 |
2 |
2 |
2 |
2 |
3 |
3 |
3 |
3 |
||
(A+B+C) x 2 (max. = 20) |
12 |
12 |
12 |
12 |
16 |
16 |
18 |
16 |
20 |
20 |
20 |
20 |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct photomotor reflex of pupil (§) |
N¥ |
N¥ |
N |
N¥ |
N¥ |
N¥ |
N¥ |
N¥ |
N¥ |
Rɸ |
N¥ |
Rɸ |
||
Iris |
Congestion 0 – 2 |
1α |
1α |
1α |
1α |
1α |
1α |
1α |
1α |
1α |
1α |
1α |
1α |
|
x 5 (max. = 10) |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
(§) N = Normal – R = Reduced – No reflex |
||||||||||||||
Cornea |
A) Opacity 0 – 4 |
2 |
2 |
2 |
2 |
4β |
2 |
2 |
2β |
3 |
3 |
2 |
3 |
|
B) Area affected 1 – 4 |
3 |
3 |
3 |
4 |
1 |
4 |
4 |
4 |
3 |
4 |
4 |
1 |
||
A x B x 5 (max. = 80) |
30 |
30 |
30 |
40 |
20 |
40 |
40 |
40 |
45 |
60 |
40 |
15 |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Individual ocular irritation score IOI (max. 110) |
47 |
47 |
47 |
57 |
41 |
61 |
63 |
61 |
70 |
85 |
65 |
40 |
||
Observations:
£: Presence of a whitish humor on the edge of the eyelids.
¥: Permanent myosis with preservation of direct photomotor reflex.
ɸ: Permanent myosis with solw-motion photomotor reflex.
α: Circumcorneal injections + congestion of the iris.
β: Presence of a membrane on half of the corneal surface.
Mean score per zone |
Conj. + Iris + Corn. |
Conj. + Iris + Corn. |
Conj. + Iris + Corn. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
12.00 |
5.00 |
32.50 |
16.50 |
5.00 |
35.00 |
20.00 |
5.00 |
40.00 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Mean ocular irritation score MOI Standard deviation S |
|
49.50 5.00 |
|
56.50 10.38 |
|
65.00 18.71 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Observations: £: Presence of a whitish humor on the edge of the eyelids. ɸ: Permanent myosis with solw-motion photomotor reflex. ?: Impossible read due to corneal opacification. α: Circumcorneal injections + congestion of the iris. x: Well-defined neovascularization.
Given the importance of lesions in the eye, some readings could not be performed normally. As a result, two types of calculations have been performed: - On the one hand, assuming that the impossible readings are negative (= 0), which makes it possible to determine a MINIMUM VALUE. - And on the other hand, by attributing to these readings the highest possible score, which determines the MAXIMUM VALUE. Table 2: Summary of various MOI
Minimum Acute Eye Irritation Index (AEI): 91.00 at D7 Maximum Acute Eye Irritation Index (AEI): 96.00 at D7
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the test conditions, Terbium trinitrate is considered as extremely irritant to the eye.
- Executive summary:
An eye irritation study was performed with Terbium trinitrate in rabbits. The method followed was similar to the OECD Guideline 405 and the study was not performed in accordance with GLP. A single dose of Terbium trinitrate in its original form was introduced into the conjunctival sac of the left eye of 4 rabbits/groups. The right eye was not treated and served as control. The eyes were not rinsed after administration of Terbium trinitrate for one treatment group and the eyes were rinsed 30 seconds after administration of Terbium trinitrate for the other treatment group
Ocular reactions were observed 1 hour and 1, 2, 3, 4 and 7 days after the administration.
Chemosis (grade 4), enanthema (score 1 - 3), congestion of iris (score 1 - 2) and corneal opacity (score 2 - 4) were observed in all animals at 1h and remained present at the end of the observation study (day 7).
Terbium trinitrate has induced irreversible effects on the rabbit eyes and is therefore classified as category 1 according to the UN GHS and CLP criteria.
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.