Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 October 2004 to 2 November 2004
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
EC Number:
255-255-2
EC Name:
O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
Cas Number:
41198-08-7
Molecular formula:
C11H15BrClO3PS
IUPAC Name:
4-bromo-2-chlorophenyl ethyl (propylsulfanyl)phosphonate
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: none
Analytical verification of test atmosphere concentrations:
yes
Remarks:
2.2 mg/L
Duration of exposure:
ca. 4 h
Concentrations:
2 mg/L
No. of animals per sex per dose:
5 animals/sex/gp
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.2 mg/L air (analytical)
Based on:
other: no deaths observed
Exp. duration:
4 h

Any other information on results incl. tables

Mortality:

No deaths were observed.

 

Clinical observations:

During exposure clinical observations were associated with restraint, including wet fur and salivation. In addition all animals had increased breathing rate.

 

Post exposure hunched posture and piloerection were observed in one female.

 

Changes indicative of irritation of the respiratory tract (increased breathing rate and abnormal respiratory noise in some animals) were observed post exposure.

 

By day 3, post exposure, the clinical condition of the animals had greatly improved, with all animals fully recovered by day 7 of the study.

 

Bodyweight:

Three males and 1 female had gained weight by day 8 of the study. All males and 2 females had gained weight by the end of the study. The remaining females showed some evidence of weight gain during the study.

 

Necropsy:

There were no test material related changes observed.

 

Table 7.2.2-1: Particulate concentration

Target particulate concentration

(mg/L)

Measured particulate concentration (mg/L)

Mean ± SD

2

2.20±0.25

 

Table 7.2.2-2: Aerodynamic particle size distribution

Time into exposure
(minutes)

Median size (MMAD) (um)

GSD

62

3.51

1.65

180

3.01

1.59

Applicant's summary and conclusion

Conclusions:
Nose only exposure to a particulate concentration of 2.2 mg Profenofos Technical (CGA15324)/L resulted in no deaths and no adverse effects. It is concluded that the LD50 of Profenofos Technical (CGA15324) exceeds 2.2 mg/L.
Executive summary:

A group of 5 male and 5 female SD rats were exposed nose only for a single 4 hour period to Profenofos Technical (CGA15324) at a target particulate concentration of 2 mg/L. Test atmospheres were analysed for particulate concentration and Profenofos Technical (CGA15324). The particle size distribution of the test atmosphere was analysed twice 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: 2.2 mg/L, MMAD 3.51 and 3.01 um, GSD 1.675 and 1.59.

 

There were no deaths. Transient signs of respiratory irritation were seen in all animals. There were no test material related macroscopic findings observed at necropsy.

 

Nose only exposure to a particulate concentration of 2.2 mg Profenofos Technical (CGA15324)/L resulted in no deaths and no adverse effects. It is concluded that the LD50 of Profenofos Technical (CGA15324) exceeds 2.2 mg/L.