Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 233-237-5 | CAS number: 10099-58-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 Mar - 30 Mar 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): Chlorure de Lanthane
- Lanthane chlorure Solution: 24.1%
- Physical state: colorless liquid
- Analytical purity: 99.1% (of the test item)
- Lot/batch No.: 9935001
- Storage condition of test material: at room temperature
- pH: 3.1
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2.7 ± 0.2 kg
- Housing: individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm)
- Diet (ad libitum): 112 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France)
- Water (ad libitum): drinking water, filtered by FG Millipore membrane (0.22 µm)
- Acclimation period: at least 5 days before beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 12 cycles/h of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the unchanged solution
- Concentration (if solution): 24.1%
- Duration of treatment / exposure:
- 21 days (the eyes were not rinsed after administration of the test substance)
- Observation period (in vivo):
- 21 day
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: According to OECD 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: whitish purulent discharge
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: whitish purulent discharge
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: whitish purulent discharge, day 8-11: score 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: day 5 - 9: score 3
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- intensity
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: cornea score area: mean 1.3, max. 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- intensity
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: cornea score area: mean 2, max. 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- intensity
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: cornea score area: mean 1.7, max. 2
- Irritant / corrosive response data:
- Very slight to moderate conjunctival reactions were observed in all animals from day 1: a very slight to moderate chemosis (grade 1 to 3), a very slight to moderate redness of the conjunctiva (grades 1 to 3). The reactions persisted up to the end of the observation period (day 21).
A slight iritis (grade 1) was noted in all animals on day 2, it persisted up to day 5 or 8.
A very slight or slight corneal opacity (grades 1 to 2) was recorded in all animals from day 2. It persisted up to the end of the observation period (day 21) in two animals.
Mean scores calculated for each animal over 24, 48 and 72 h were: 3.0, 3.0 and 2.0 for chemosis; 3.0, 2.0 and 2.0 for redness of the conjunctiva; 1.0, 1.0 and 1.0 for iris lesions and 1.0, 2.0 and 2.0 for corneal opacity. - Other effects:
- A whitish purulent discharge was observed in all animals.
Furthermore, a whitish coloration of the conjunctiva was recorded in two animals.
Alopecia around the eye and neovascularisation were noted in all animals.
All these further effects were not reversible, except the whitish coloration of the conjunctiva in one animal.
Any other information on results incl. tables
Individual ocular examinations and mean values of the scores recorded at 1, 24, 48 and 72 h for each animal:
Rabbit |
Region of eye |
Description of ocular reactions |
1 h |
24 h |
48 h |
72 h |
Mean irritation score |
1 |
Conjunctivae |
Chemosis |
2 |
3 |
3 |
3 |
3.0 |
|
|
Redness |
0 |
3 |
3 |
3 |
3.0 |
|
|
Discharge |
E |
2 |
S |
S |
|
|
Iris |
|
0 |
1 |
1 |
1 |
1.0 |
|
Corneal opacity |
Intensity |
0 |
1 |
1 |
1 |
1.0 |
|
|
Area |
0 |
2 |
1 |
1 |
1.3 |
|
other |
|
- |
- |
- |
- |
|
|
Fluorescein |
|
- |
U |
U |
U |
|
2 |
Conjunctivae |
Chemosis |
2 |
3 |
3 |
3 |
3.0 |
|
|
Redness |
0 |
2 |
2 |
2 |
2.0 |
|
|
Dicharge |
E |
S |
S |
S |
|
|
Iris |
|
0 |
1 |
1 |
1 |
1.0 |
|
Corneal opacity |
Intensity |
0 |
2 |
2 |
2 |
2.0 |
|
|
Area |
0 |
2 |
2 |
2 |
2.0 |
|
other |
|
- |
- |
- |
- |
|
|
Fluorescein |
|
- |
U |
U |
U |
|
3 |
Conjunctivae |
Chemosis |
2 |
2 |
2 |
2 |
2.0 |
|
|
Redness |
0 |
2 |
2 |
2 |
2.0 |
|
|
Discharge |
E |
S |
S |
S |
|
|
Iris |
|
0 |
1 |
1 |
1 |
1.0 |
|
Corneal opacity |
Intensity |
0 |
2 |
2 |
2 |
2.0 |
|
|
Area |
0 |
2 |
2 |
1 |
1.7 |
|
other |
|
- |
- |
- |
- |
|
|
Fluorescein |
|
- |
U |
U |
U |
|
Mean irritation score on 24, 48 and 72 h
U = Fluorescein used
E = Scoring masked by residual test substance
S = Whitish purulent discharge
Individual ocular examinations of the scores recorded at 7, 14 and 21 days (scores recorded daily, results not shown here)
Rabbit |
Region of eye |
Description of ocular reactions |
7 d |
14 d |
21 d |
1 |
Conjunctivae |
Chemosis |
3 |
2 |
2 |
|
|
Redness |
3 |
3 |
2 |
|
|
Discharge |
S |
S |
S |
|
Iris |
|
1 |
0 |
0 |
|
Corneal opacity |
Intensity |
1 |
1 |
1 |
|
|
Area |
1 |
1 |
1 |
|
other |
|
- |
A |
A/N |
|
Fluorescein |
|
U |
U |
U |
2 |
Conjunctivae |
Chemosis |
1 |
1 |
1 |
|
|
Redness |
2 |
1 |
1 |
|
|
Dicharge |
1 |
S |
S |
|
Iris |
|
0 |
0 |
0 |
|
Corneal opacity |
Intensity |
0 |
0 |
0 |
|
|
Area |
0 |
0 |
0 |
|
other |
|
- |
A/CB |
N |
|
Fluorescein |
|
U |
U |
- |
3 |
Conjunctivae |
Chemosis |
2 |
2 |
2 |
|
|
Redness |
3 |
2 |
2 |
|
|
Discharge |
1 |
S |
S |
|
Iris |
|
1 |
0 |
0 |
|
Corneal opacity |
Intensity |
2 |
1 |
1 |
|
|
Area |
1 |
1 |
1 |
|
other |
|
CB |
CB/N |
CB/N |
|
Fluorescein |
|
U |
U |
U |
U = Fluorescein used
S = Whitish purulent discharge
A = Alopecia around the eye
N = Neovascularisation
CB = Whitish coloration of the conjunctiva
Applicant's summary and conclusion
- Interpretation of results:
- other: risk of serious damage to eyes
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.
