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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Limited detail on test substance, methods and animals/conditions. 24-hour exposure duration under occlusive dressing.

Principles of method if other than guideline:

Method: other: Insufficient detail to fully assess comparability with OECD guideline.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid

EC Number:

239-931-4

EC Name:

[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid

Cas Number:

15827-60-8

Molecular formula:

C9H28N3O15P5

IUPAC Name:

[(bis{2-[bis(phosphonomethyl)amino]ethyl}amino)methyl]phosphonic acid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: No data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml (although the recommended dose of 0.5 ml was achieved for the formulation, this means that the limit dose for the active acid was not attained. The level of irritation of the anhydrous active acid may therefore be underestimated by this study.However, the presence of HCl in the formulation would be predicted to exacerbate the effect seen).

Duration of treatment / exposure:

24 hour(s)

Observation period:

Seven days (1, 24, 48, 72, 120 and 168 hours)

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: No data
- % coverage: No data but 1X1 inch square patch used
- Type of wrap if used: Occlusive plastic wrap.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No Data
- Time after start of exposure: No data


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Average maximum score

Basis:

mean

Time point:

other: 24 hours

Score:

1

Max. score:

8

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

other: Individual animal readings were not available.

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

other: Individual animal readings were not available.

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

other: Individual animal readings were not available.

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

other: Individual animal readings were not available.

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

other: Individual animal readings were not available.

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

other: Individual animal readings were not available.

Irritant / corrosive response data:

After one hour there were no skin changes, but by 24 hours there was grade 1 erythema (no oedema) in all three animals. This erythema had disappeared by 48 hours.

Other effects:

None

Any other information on results incl. tables

Scored responses were as follows.  
1 hour        0,0,0
24 hours    1,1,1 (barely perceptible erythema; no oedema)
48-168 hours    0,0,0

The average maximum score was 1.0 out of a possible 8.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a skin irritation study (reliability score 2) conducted prior to the adoption of OECD test guidelines and GLP, DTPMP-H was mildly irritating to rabbit skin.

Executive summary:

In a skin irritation study (reliability score 2) conducted prior to the adoption of OECD test guidelines and GLP, 0.5 ml undiluted 58% w/w solution of diethylenetriamine penta(methylene phosphonic acid) was applied to the clipped, intact skin of three New Zealand white rabbits for 24 hours. A 1x1 inch square patch was used and covered with an occlusive dressing. Skin reactions were scored at 1, 24, 48, 72, 120 and 168 hours using the Draize scoring system. After one hour there were no skin changes, but by 24 hours there was grade 1 erythema (no oedema) in all three animals. This erythema had disappeared by 48 hours. Therefore the test substance was mildly irritating to the skin of rabbits.