Registration Dossier
Registration Dossier
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EC number: 616-639-9 | CAS number: 78620-07-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: conducted to OECD/EC guidelines with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): Belcor 575 trisodium salt
- Physical state: Aqueous solution
- Aqueous sodium salt solution formed by neutralising acid with sodium hydroxide (52% Belcor 575, 48% NaOH)
- Lot/batch No.: PAD-A-240-226-D
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: 9 - 13 weeks old
- Weight at study initiation: 2710 - 2960 grams
- Housing: Metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag No. 814
- Water (e.g. ad libitum): ad libitum fresh water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 36 cm2
- % coverage: 12 - 16 cm2
- Type of wrap if used: Gauze
Three New Zealand white rabbits were treated dermally with 0.5ml of Belcor 575 trisodium salt. The test material was applied on a gauze patch to the shaved right flank of each animal. A control patch moistened with distilled water was applied to the contralateral flank. The patches were loosely covered with aluminium foil and held in place for 4 hours by adhesive tape.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Not irritating
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: not irritating
Any other information on results incl. tables
The skin reactions were evaluated according to the OECD scoring system 1, 24, 48 and 72 hours after removal of the gauze patches. Erythema was observed at 1 hour in two of the animals and at all the observation times in one animal. The observation period was extended to 7 days to determine reversibility of the reactions. All animals appeared normal within 7 days. The reactions observed 24 to 72 hours after removal of the dressings are below the threshold of significance according to the EEC directive 83/467.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Trisodium [carboxy(oxido)methyl]phosphonate is not irritating to the skin
- Executive summary:
In a primary dermal irritation study 3 male New Zealand white rabbits of 9 -13 weeks old were dermally exposed to 0.5mL of Trisodium [carboxy(oxido)methyl]phosphonate for 4 hours to a 12 -16 cm2 area. Animals then were observed for 3 days.
In this study, trisodium [carboxy(oxido)methyl]phosphonate is not a dermal irritant.
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