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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

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 the test substance used in the study report: Anthranilamid
- Physical state / Appearance: solid ( powder)/brown
- Storage: at room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr . K . Thomae GmbH, D-7950 Biberach, FRG
- Age at study initiation: approx. 8 - 9 weeks
- Weight at study initiation: male animals 268 ± 2.5 g, female animals 189 ± 7.1 g.
- Housing: groups of five in cages type D III of Becker, without bedding.
- Diet: KLIBA rat/mouse laboratory diet 24-343-4 10 mm pellets (Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland), ad libitum.
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): Fully aircondidtioned
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
air
Details on inhalation exposure:
- Generation of the inhalation atmosphere: A dust aerosol was generated by means of a dosing-wheel dust generator (Gericke/BASF). The test substance was mixed with 1 wt% of Aerosil in order to achieve a more uniform dust concentration in air. The concentration was adjusted by varying rotation of the metering disc.
- The following air flow (supply air) was set: compressed air : 1500 L/h. The exposure system was placed in an air-conditioned laboratory. Temperatures in the exposure system were 19 - 25°C. By means of an exhaust air system the pressure ratios in the inhalation system were adjusted in such a way that the amount of exhaust air was about 10% lower (excess pressure). This ensured that the mixture of test substance and air was not diluted with laboratory air in the breathing zones of the animals.

Analytical method used: Gravimetric determination of the inhalation atmosphere concentration. The preweighed filter was placed into the filtration
equipment. By means of a vacuum compressed air pump a volume of the dust aerosol was drawn through the filter. The dust concentration in mg/L was calculated from the difference between the preweight of the filter and the weight of the filter after sampling, with reference to the sample volume of the inhalation atmosphere. The concentration was corrected for the amount of the additive (1 sample about hourly).
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5.4 mg/L
No. of animals per sex per dose:
5
Control animals:
other: historical control for body weight
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weight was checked before the beginning of the test, after 7 days and at the end of the observation period. Clinical findings were recorded several times during exposure and at least once on each workday in the observation period. A check for dead animals was made daily.
- Necropsy of survivors performed: yes, at the end of the 14-day observation period the animals were sacrificed with CO2 and were subjected to gross-pathological examination.
Statistics:
On the basis of the binomial test (Wittig, H. : Mathematische Statistik 1974, pp. 32 - 35).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.4 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
None
Clinical signs:
other: - During exposure: accelerated respiration - After exposure and during observation period: accelerated respiration (10/10), reddish nasal (2/10) and eye discharges (1/10) (blood test positive), and fur discoloured with the test substance (10/10) was obser
Body weight:
- Mean body weight for male animals: 268 g at study start, 330 g after 14 days
- Mean body weight for female animals: 189 g at study start, 206 g after 14 days
Gross pathology:
No pathological findings noted.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information