Registration Dossier

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:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.