Registration Dossier
Registration Dossier
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EC number: 230-898-1 | CAS number: 7360-53-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July - August 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline- and GLP-compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Aluminium triformate
- EC Number:
- 230-898-1
- EC Name:
- Aluminium triformate
- Cas Number:
- 7360-53-4
- Molecular formula:
- CH2O2.1/3Al
- IUPAC Name:
- aluminium triformate
- Details on test material:
- Test article: Altriform CFD
Chemical name: Aluminiumtriformiat
Article No.: 335204
Batch No.: 46799/01
Activity: approx. 97%
Description: White powder
Stability: 12 months
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Chbb:HM(SPF)-Littlerussian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Weight at study initiation: 3.1, 2.7, 2.9 kg
- Housing: individual caging in PPO cages
- Diet (e.g. ad libitum): Altromin 2123
- Water (e.g. ad libitum): domestic quality drinking water acidified with HCl to pH 2.5
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 3 °C
- Humidity (%): 55 % +/- 15 %
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1h, 24h, 48h, 72h, 7d, 14d, 21d, 28d, 35d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing with 20 mL 0.9 % sodium chloride solution
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Reversibility:
- other: reversible in 2/3 animals, not reversible in 1/3 animals
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2.2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2.9
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Well defined signs of irritation were observed in the treated eyes. One animal still showed irreversible effects at the end of the study on Day 35.
Any other information on results incl. tables
Mean values (24, 48 and 72 hours):
Animal No. |
Cornea opacity |
Iris lesion |
Conjunctivae |
||
- Fluorescein |
+ Fluorescein |
Redness |
Oedema |
||
2182 |
1.00 |
1.67 |
1.00 |
2.00 |
2.67 |
2361 |
1.00 |
1.00 |
1.00 |
2.00 |
3.00 |
2366 |
1.00 |
2.00 |
1.00 |
2.67 |
3.00 |
Mean
Cornea opacity |
Iris lesion |
Conjunctivae |
||
- Fluorescein |
+ Fluorescein |
Redness |
Oedema |
|
1.0 |
1.6 |
1.0 |
2.2 |
2.9 |
See attached document for individual results.
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the directive of the EEC commission 93/21/EEC from May 4, 1993 Aluminiumtriformiat, Batch No. 46799/01, shall be classified as "R41 - risk of serious damage to eyes".
- Executive summary:
The local effect of Aluminiumtriformiat was investigated according to the method recommended in the OECD Guideline 405, "Acute Eye Irritation/Corrosion", February 1987, and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", January 1997.
Three female albino rabbits were exposed to 0.1 g of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours as well as 7, 14, 21, 28 and 35 days after dosing.
Well-defined signs of irritation were observed in the treated eyes. One animal still showed irreversible effects at the end of the study on Day 35.
According to the directive of the EEC commission 93/21/EEC from May 4, 1993 Aluminiumtriformiat, Batch No. 46799/01, shall be classified as "R41 - risk of serious damage to eyes".
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