Registration Dossier
Registration Dossier
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: 607-104-0 | CAS number: 225375-65-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-08-13 to 1984-11-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes
Test material
- Reference substance name:
- Silicophosphonat
- IUPAC Name:
- Silicophosphonat
- Details on test material:
- - Name of test material (as cited in study report): Silicophosphonat
- Substance type: Liquid
- Lot/batch No.: W 760/84
- Composition: 39% in Water, NaOH
- Expiration date of the lot/batch: stability of the substance was verified by a repaeated analysis.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main
- Age at study initiation: not given
- Weight at study initiation: mean 2.6 kg
- Housing: individually in metal cages with mesh walk floors, floor area 40x51 cm
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): 250 mL per animal per day
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 °C
- Humidity (%): 30-70 %
- Air changes (per hr): not given
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
time points were 1, 24, 48 and 72 hours - Number of animals or in vitro replicates:
- 3 (1 male, 2 female)
- Details on study design:
- PROCEDURE
Single application to the conjunctival sac of the right eyelid; the substance ist not washed out.
SCORING SYSTEM:
Chemosis and Cornea (Opacity degree of Density):
0 = None
1 = Slight
2 = Well-defined
3 = Severe
4 = Very severe
Conjunctivae redness:
0 = normal
1 = slight
2 = well-defined
3 = severe
Iris:
0 = normal
1 = circum corneal injection
2 = iritis
Calculation of the mean according to 83/467/ECC Criteria of July 29th, 1983 ( For calculation of the means of opacity, iris, redness and swelling only the reading of 24, 48 and 72 hours are used.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: based on 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: based on 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: based on 24, 48 and 72 h
- Score:
- 0.9
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- only female at 72 h: score 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: based on 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 48 h
- Irritant / corrosive response data:
- The substance had no effects on the cornea and the iris. Well-defined effects on the conjunctiva (Redness) 1 and 24 h after the application were fully reversivble within 72h after the treatment in all but one animal (female) The maximum score did not exceed 2. Well-defined effects on the conjunctiva (Chemosis) 1 hour after the application were fully reversivble within 48 h after the treatment. The mean score at 24 h was 1.0.
- Other effects:
- No other symptoms were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Under the conditions of this study Silicophosponate is not irritating to rabbit eyes. Well-defined effects on the conjuntiva were reversible. According to guidelines for classification, the substance is not irritating.
- Executive summary:
The primary irritation potential of Silicophosphonat on the eyes of Vienna white rabbits was examined in this study. Under the conditions of this study, Silicophosphonat is considered not irritating to rabbit eyes. Conjuctival effects were reversible and did not exceed values corresponding to an irritating potential.
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.
