N-(carboxymethyl)-N-(phosphonomethyl)glycine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 31, 1988 to June 14, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(carboxymethyl)-N-(phosphonomethyl)glycine

EC Number:

227-824-5

EC Name:

N-(carboxymethyl)-N-(phosphonomethyl)glycine

Cas Number:

5994-61-6

Molecular formula:

C5H10NO7P

IUPAC Name:

2-[(carboxymethyl)(phosphonomethyl)amino]acetic acid

Details on test material:

- Name of test material (as cited in study report): N-Phosphonomethyl-iminodiacetic acid or PMIE
- Physical state: solid white powder
- Analytical purity: 98,5

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Møllegaard Breeding Centre Ltd, Ejby, DK-4623 Ll. Skensved
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 147-154 g
- Fasting period before study: 18 h
- Housing: Macrolone cages type III, 2 or 3 to a cage, males and females separated. The bedding was softwood sawdust "Spanvall Special White" from Spanvall Ltd., Jorløse, DK-4490 Jerslev.
- Diet : "Altromin 1314" from Chr. Petersen Ltd. DK-4100 Ringsted, ad libitum
- Water : ad libitum, acidified with hydrochloric acid to pH 2,5.
- Acclimation period: None because rats were born next door to laboratory and had been kept in the same inviroment as during the experiment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21, +/-2
- Humidity (%):55, +/- 15
- Air changes (per hr): 6 times
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: May 31, 1988.To: June 14, 1988.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 1 ml per 100 g body weight

Doses:

1

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: obs: everyday and weight: day 0, 1 and 14
- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

It was expected that the LD50 would exceed 2 g test material/kg body weight. Therefore the study was initiated with one group consisting of 5 males and 5 females, which all were adnistered 2000 mg N-(carboxymethyl)-N-(phosphonomethyl)-glycine per kg of body weight.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Shortly after the treatment piloerection was observed in all rat. Normal behhaviour and apperance were observed from day 1 and througout the rest of the experiment.

Gross pathology:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Since no rats died of the treatment, the oral LD50 of N-(carboxymethyl)-N-(phosphonomethyl)-glycine must exceed 2000 mg/kg body weight.