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

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not reported

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment

Justification for data waiving:

other:

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:

1984

Report date:

1984

Materials and methods

Principles of method if other than guideline:

Acute inhalation toxicity of test material was determined by exposing test animals for 4 h to test material aerosols. All animals were observed for mortality and clinical signs during the l4-day postexposure period.

GLP compliance:

no

Test type:

other: Acute inhalation toxicity

Limit test:

no

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): Glyphosate intermediate
- Analytical purity: 97.28 %
- Lot/batch No.: LBIG-12-026

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Not reported

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

not specified

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

TEST ATMOSPHERE
- Particle size distribution: Approximately 50 % of the particles were less than 10 microns in diameter
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 7.2 microns

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

4 h

Concentrations:

6.1 mg test material/L of air

No. of animals per sex per dose:

Five

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of clinical observations and weighing: Animals were observed for mortality and clinical signs during the exposure and twice daily during the 14 d postexposure period. Body weights were recorded prior to exposure and on postexposure Days 2, 3, 4, 7 and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Complete gross necropsy examination

Statistics:

Not reported

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 6.1 mg/L air

Exp. duration:

4 h

Remarks on result:

other: No mortality was observed

Mortality:

No mortality resulted from the inhalation exposure to 6.1 mg/L of test material.

Clinical signs:

other: Nasal discharge and colored material about the eyes, nose and mouth observed in treated animals.

Body weight:

Body weights of treated animals were depressed below their pre-exposure weights on postexposure Days 2-4. By Day 3 or 4, all animals were gaining weight at a rate equivalent to controls.

Gross pathology:

Red foci on the lung and thymus observed at a greater frequency in the treated group as compared to controls.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: EU CLP

Conclusions:

Under the test conditions, the inhalation LC50 of test material is considered to > 6.1 mg/L and is not considered to present a significant acute inhalation hazard.

Executive summary:

A study was conducted to evaluate the inhalation toxicity of test material in Sprague Dawley albino rats.

 

5 animals/sex were exposed to test material dust aerosol atmosphere at a concentration of 6.1 mg/L of air for 4 h. Animals exposed to air only served as control. Animals were observed for mortality and clinical signs. On postexposure Day 14, all, animals were killed and given a complete gross necropsy examination.

 

No mortality was observed. Body weights of treated animals were depressed below their pre-exposure weights on postexposure Days 2-4. By Day 3 or 4, all animals were gaining weight at a rate equivalent to controls. Nasal discharge and colored material about the eyes, nose and mouth observed in treated animals. Red foci on the lung and thymus observed at a greater frequency in the treated group as compared to controls.

Under the test conditions, the inhalation LC50 of test material is considered to > 6.1 mg/L and is not considered to present a significant acute inhalation hazard.