Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Purity : 96.7 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Two groups of rats (5 males and 5 females) were used for the study.
TEST ANIMALS
- Source: Jai Research Foundation
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: male between 258 and 196 g; female between 184 and 162 g kg
- Housing: the rats are divided in two groups
- Diet:. ad libitum
- Water : ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 64-66%
- Air changes (per hr): min 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: 80% polyethylen glycol in distilled water
Remarks:
The test item is pratically not soluble in distilled water.
Duration of exposure:
4 h
Concentrations:
Rat from Group I were exposed to 80% polyethylene glycol in distilled water and served as the control group. Rats from Group II were exposed to the maximum achievable breathing zone concentration (2.865 mg/l air) of test item in 80% polyethylene glycol at the calculated nominal concentration of 23.111 mg/l of auer in the inhalation chamber.
No. of animals per sex per dose:
Two groups of rats (5 males and 5 females) were used for the study.
Control animals:
yes
Details on study design:
Observation period: 14 days
All rats were observed for any signs and mortality at hourly intervals during the 4 h exposure period and at 1 h after the exposure on the day of exposure. The surviving rats were observed twice a day for morbidity and mortality for a period of 14 day following exposure. The clinical signs were recorded once a day.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2 865 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality occurred at the maximum achievable breathing zone concentration.
Clinical signs:
other: nasal discharge, nasal irritation, lethargy
Body weight:
No effect.
Gross pathology:
No lesion of toxicological sigificance were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Since no mortality occurred at the maximum achievable breathing zone concentration of d-trans Allethrine 75/25 in 80% of polyethylene glycol at the calculated nominal concentration of 23.111 mg/l of aier, the substance was not classified for this endpoint.