1H-1,2,4-Triazole-1-carboxamide, 4-amino-N-(1,1-dimethylethyl)-4,5-dihydro-3-(1-methylethyl)-5-oxo-

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 Sept 1994 to 4 Oct 1994

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

(1981)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

Version / remarks:

(1984)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1150 (Acute inhalation toxicity)

Version / remarks:

(1989)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF 59 NohSan No. 4200 (Guidance on toxicology study data for application of agriculture chemical registration) (1985)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-amino-N-tert-butyl-5-oxo-3-(propan-2-yl)-4,5-dihydro-1H-1,2,4-triazole-1-carboxamide

EC Number:

603-373-3

Cas Number:

129909-90-6

Molecular formula:

C10H19N5O2

IUPAC Name:

4-amino-N-tert-butyl-5-oxo-3-(propan-2-yl)-4,5-dihydro-1H-1,2,4-triazole-1-carboxamide

Constituent 2

Reference substance name:

Technical Grade MKH 3586

IUPAC Name:

Technical Grade MKH 3586

Details on test material:

- Name of test material (as cited in study report): Technical Grade MKH 3586
- Physical state: Beige power
- Analytical purity: 97.8 - 98.2%
- Purity test date: 17 Jun 1994
- Lot/batch No.: 17004/93
- Expiration date of the lot/batch: 6 months from purity test date

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 4 h

Concentrations:

2242 mg/m3 (2.242 mg/L)

No. of animals per sex per dose:

6 animals/sex/dose group

Control animals:

yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2 242 mg/m³ air (analytical)

Based on:

other: no mortality observed

Exp. duration:

4 h

Any other information on results incl. tables

OBSERVATIONS:

Clinical signs of toxicity:

Few clinical signs were observed and included increased lacrimation, nasal/oral staining and an unkempt appearance.

 

Mortality:

All animals survived to the scheduled necropsy

 

Bodyweight and bodyweight gain:

No test material related changes were observed

 

Sacrifice and Gross Pathology:

No gross lesions attributed to the test material were observed

                                      

Table 7.2.2: Aerodynamic particle size distribution

Sample time (hr)	MMAD (uM)	GSD
1	4.28	2.19
2	3.58	1.86
3	3.46	2.08
4	3.56	2.00
Mean (±SD)	3.72 (0.38)	2.03 (0.14)

Applicant's summary and conclusion

Conclusions:

Nose only exposure to a particulate concentration of 2.242 mg MKH 3586/L resulted in no deaths and no adverse effects. It is concluded that the LD50 exceeds 2.242 mg/L.

Executive summary:

A group of 6 male and 6 female SD rats were exposed nose only for a single 4 hour period to MKH 3586 (as a respirable dust) at a target concentration of 2 mg/L. Test atmospheres were analysed for particulate concentration and MKH 3586. The particle size distribution of the test atmosphere was analysed hourly during the exposure period. Following exposure, the animals were retained without treatment for 14 days. Clinical observations and bodyweights were recorded throughout the study and at the end of the scheduled period the animals were killed and subjected to a gross examination post mortem.

 

The achieved test atmospheres had the following characteristics: Achieved concentration: 2.242 mg/L, MMAD ranged from 3.46 – 4.28 um, GSD ranged from 1.86 – 2.19.

 

There were no deaths, with clinical signs of toxicity limit to signs of respiratory irritation (increased lacrimation, nasal/oral staining) and an unkempt appearance. There were no test material related macroscopic findings observed at necropsy.

 

Nose only exposure to a particulate concentration of 2.242 mg MKH 3586/L resulted in no deaths and no adverse effects. It is concluded that the LD₅₀ exceeds 2.242 mg/L.