A mixture of: tetrasodium-phosphonoethane-1,2-dicarboxylate; hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 23 september 1992 To 26 September 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Draize test.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: tetrasodium-phosphonoethane-1,2-dicarboxylate; hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate

EC Number:

410-800-5

EC Name:

A mixture of: tetrasodium-phosphonoethane-1,2-dicarboxylate; hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate

Cas Number:

143239-08-1

Molecular formula:

There is no molecular formula available, as the reference substance is a multi- constituent reaction mass. The molecular formulae of the constituents are documented in section 1.2.

IUPAC Name:

dotriacontasodium (1R,2S,3R)-1-phosphonatobutane-1,2,3,4-tetracarboxylate (1R,2S,3S)-1-phosphonatobutane-1,2,3,4-tetracarboxylate (1S,2R,3S)-1-phosphonatobutane-1,2,3,4-tetracarboxylate (1S,2S,3S)-1-phosphonatobutane-1,2,3,4-tetracarboxylate (2R)-2-phosphonatobutanedioate (2S)-2-phosphonatobutanedioate

Details on test material:

- Physical state: white powder
- Stability under test conditions:
- Storage condition of test material: room temperature under silica gel

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.31-2.82 kg
- Housing: individually in suspended metal cages
- Diet : ad libitum (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, U.K.)
- Water : ad libitum
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 56-58
- Air changes (per hr): 15
- Photoperiod : 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: 23 September 1992 To: 26 September 1992

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE: none

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: dorsal/flank area
- % coverage: no data
- Type of wrap if used: elasticated corset (TUBIGRIP)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material were removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: no data


SCORING SYSTEM: according to the Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, and 72 hr

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight erythema was noted at three treated skin sites one hour after patch removal. all treated skin sites appeared normal 24 hours after treatment.

Other effects:

None

Any other information on results incl. tables

Table 7.3.1/1: Irritant/corosive response data for each male animal after 4h exposure under semiocclusive coverage

score at time point/ Reversibility	Erythema Max. score:4	Edema Max. score:2
1h	1/0/0/1/0/1	0/0/0/0/0/0
24h	0/0/0/0/0/0	0/0/0/0/0/0
48h	0/0/0/0/0/0	0/0/0/0/0/0
72h	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test, ITC 288 was non-irritant to rabbit skin. Therefore, no classification is required according to the EU legislation (CLP regulation (1272/2008) and Directive 67/548/EEC).

Executive summary:

In a primary dermal irritation study (Tuffnell, 1992), six male New Zealand rabbits were dermally exposed to 0.5 g of ITC 288, moistened with 0.5 ml of distilled water for 4 hours under an semi-occlusive dressing. Animals were observed for 3 days. Irritation was scored by the draize scale. A single 4-hour, semi-occluded application of ITC 288 to the intact skin of six rabbits produced very slight erythema. All treated skin sites appeared normal after treatment. Mean scores (24, 48, 72 hours) was 0.0 for erythema and edema. Under the test conditions of this study, ITC 288 is not considered as skin irritant according to the EU legislation (CLP regulation (1272/2008) and Directive 67/548/EEC).

This skin irritation study is classified as acceptable. It satifies the guideline requirement for a skin irritation in the rabbit.