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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key 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 402 (Acute Dermal Toxicity)

Version / remarks:

Conducted prior to adoption of OECD test guidelines.

Deviations:

yes

Remarks:

Limited detail on test substance, methods and animals/conditions.

Principles of method if other than guideline:

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

GLP compliance:

no

Test type:

standard acute method

Limit test:

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

Sex:

male/female

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: 1.8 to 2.0 kg
- Fasting period before study: 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

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: 'plastic strips'


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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Constant volume or concentration used: No data

Duration of exposure:

24 hours

Doses:

3160, 5010, 7940 and 7940 mg/kg bw

No. of animals per sex per dose:

One male or female animal per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, and macroscopic examination of all animals.

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 940 mg/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to >4605 mg active acid/kg bw

Mortality:

No deaths occurred.

Clinical signs:

other: Clinical symptoms included reduced appetite and activity for 1-2 days. 

Gross pathology:

No adverse findings.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute dermal toxicity study (reliability score 2), conducted prior to the adoption of OECD test guidelines and GLP, the LD50 for DTPMP-H was >7940 mg/kg bw (equivalent to >4605 mg active acid/kg bw) in the rabbit.

Executive summary:

In an acute dermal toxicity study (reliability score 2), conducted prior to the adoption of OECD test guidelines and GLP, 58% w/w solution of DTPMP-H was applied to the clipped, intact skin of four New Zealand white rabbits, under an occlusive dressing, for 24 hours. Animals were then observed for 14 days, and all animals were examined macroscopically. No animals died and the LD₅₀ was concluded to be greater than 7940 mg/kg bw (equivalent to >4605 mg active acid/kg bw). Toxic signs included reduced appetite and activity for one to two days after treatment. There were no abnormal macroscopic findings.