Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
(1981)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-3 (Acute inhalation toxicity)
Version / remarks:
(1984)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.1150 (Acute inhalation toxicity)
Version / remarks:
(1989)
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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.