[[(phosphonomethyl)imino]bis[ethylenenitrilobis(methylene)]]tetrakisphosphonic acid, potassium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

10.05.2000 to 20.05.2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline, and in compliance with GLP. The study is read across from the sodium salt of DTPMP (CAS 22042-96-2).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphosphonic acid, sodium salt

EC Number:

244-751-4

EC Name:

[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphosphonic acid, sodium salt

Cas Number:

22042-96-2

IUPAC Name:

sodium hydrogen [10,10-dihydroxy-10-oxido-2,5,8-tris(phosphonomethyl)-2,5,8-triaza-10-phosphadec-1-yl]phosphonate

Constituent 2

Reference substance name:

[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphos phonic acid, sodium salt

IUPAC Name:

[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphos phonic acid, sodium salt

Details on test material:

- Name of test material (as cited in study report): Dequest 2066A
- Substance type: Phosphonate
- Physical state: Clear amber liquid
- Analytical purity: No data
- Purity test date: No data
- Lot/batch No.: None provided
- Expiration date of the lot/batch: None provided
- Stability under test conditions: Not provided
- Storage condition of test material: Room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN.
- Age at study initiation: 'adult'
- Weight at study initiation: 2.3 - 2.44 kg
- Housing: Individually in suspended stainless steel cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22
- Humidity (%): 46-82
- Air changes (per hr): 10-16
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 10.05.2000 to 20.05.2000

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

Four hours

Observation period:

10 days

Number of animals:

Six

Details on study design:

TEST SITE
- Area of exposure: Dorsal area of trunk
- % coverage: No data
- Type of wrap if used: The gauze patch was held in place around the cut edges with non-irritating tape, and ingestion prevented by placing an elastic wrap over the trunk and test area.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: Residual test substance was removed using gauze moistened with deionised water followed by dry gauze.

SCORING SYSTEM: Based on Draize

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0.75

Max. score:

8

Reversibility:

fully reversible within: 10 days

Irritant / corrosive response data:

Very slight to well-defined erythema on 6/6 test sites and very slight oedema on 3/6 test sites at the one hour scoring interval. The dermal irritation had resolved competely in all animals by day 10.

Other effects:

None reported.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

In a skin irritation study conducted to OECD 404 and GLP (reliability score 1) Dequest 2066A was very mildly irritating to the skin of rabbits. The result is read across from the sodium salt of DTPMP (CAS 22042-96-2).