Registration Dossier

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:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test substance: Pyrazol
Batch No.: Pyrazol 27/90
Purity: 100%
Date of manufacture: April 20, 1989
Physical state/appearance: solid (melt)/white-colourless
Storage conditions: was stored at room temperature
Stability: Stability was ensured for at least the study period.
Homogeneity: was guaranteed by purity

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
strain: SPF Wistar/Chbb : THOM ; breeding facility: Dr. K . Thomae GmbH, D-7950 Biberach, FRG)
Mean body weight at the beginning of the study: male animals 285 ± 4.0 g, female animals 188 ± 2 .1 g.
Age at the beginning of the study: approx . 8- 9 weeks
The animals were identified by color marking on the tail.
The animals were offered KLIBA rat/mouse laboratory diet 24-343-4 10 mm pellets, Klingentalmuhle AG, CH-4303 Kaiseraugst, Switzerland, and drinking water ad libitum during the post-exposure observation period.
The animals were kept in fully air-conditioned rooms in which a temperature in the range 20-24°C and relative humidity in the range 30-70% were regulated by means of a central air-conditioning system.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0.37 mg/L
No. of animals per sex per dose:
5

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.37 mg/L air
Remarks on result:
other: maximum concentration achievable
Mortality:
No mortality was observed during the study.
Clinical signs:
Clinical signs included wiping of snouts, restlessness, and attempts to escape. All animals were clear of findings by 2 hours after the beginning of exposure.
Body weight:
The body weight gain of male rats was not affected. The body weight gain of the female rats was retarded in the second week of the observation period.
Gross pathology:
No pathologic findings noted.

Any other information on results incl. tables

Cumulated lethality on day

male

female

0

0/5

0/5

1

0/5

0/5

2

0/5

0/5

7

0/5

0/5

14

0/5

0/5

Total at end of the study

0/5

0/5

Time after beginning of exposure

< ¼ h

¼ h

½ h

1 h

2 h

3 h

4 h

Animals without findings

10

10

10

Wiping of snouts

10

Restlessness

10

10

10

Attempts to escape

10

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Regarding the results of the study, the LC50 of the test substance exceeds the maximum concentration that could be technically achieved (0.37 mg/L air).
Executive summary:

The acute inhalation toxicity potential of the test substance was studied in accordance with OECD Guideline 403. Five male and five female rats were exposed to the test substance for 4 hours at a concentration of 0.37 mg/L (maximum attainable concentration). No mortality or gross pathologic findings were noted was observed.