Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
limited data to test substance, read across substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
No analytical purity; gravimetric analyses of the concentration without analytical confirmation of the composition and reanalysis of the airborne material, respectively; single instead of twice particle size distribution determination.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Mean body weight at the beginning of the test: male animals: 307 +/- 16 g, female animals 228 +/- 17 g.
Age at the beginning of the test: about 8 -10 weeks.
Identification: The animals were identified by toe amputation.
The animals were offered SSNIFF R complete diet for rats and mice, manufacturer: SSNIFF-Versuchstierdiaeten GmbH, Soest, Germany, and tap water ad libitum during the post-exposure observation period.
The animals were accommodated in fully air-conditioned rooms (required temperature 22 + 20°C, required humidity 55 + 5%) with a light/dark rhythm of 12 hours. They were housed in groups of five in cages of Becker, type D III, without bedding.

Administration / exposure

Route of administration:
other: vapour/aerosol test
Type of inhalation exposure:
nose/head only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Head-nose inhalation system INA 20 (glass/steel construction, BASF Aktiengesellschaft, V ca. 55 l); the animals are restrained in tubes and their snouts project into the inhalation chamber.
A mixture of dust and air was generated by means of a vibration aerosol generator (fluidized bed).
By means of a dust generator the substance to be tested was generated into a dust aerosol, which was passed into the inhalation system.
A vibration aerosol generator was used for generating dust. The concentration was adjusted by varying the amplitude and frequency of the vibrator.
The rate of flow was adjusted as follows: 1500 l/h of compressed air through the vibrator.
The inhalation mixture was offered to the animals for inhalation for 4 hours.
By means of an exhaust air system the pressure ratios in the inhalation chamber were adjusted in such a way that the amount of fresh air was about 10% lower. This ensured that the mixture of test substance and air was not diluted by laboratory air in the breathing zones of the animals.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5.5 mg/l
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before starting the study, after 7 days and after the end of the observation period
- Necropsy of survivors performed: yes
Statistics:
The statistical evaluation of the concentration-response relationship was carried out in accordance with the binominal test (Wittig, H.: Mathematische Statistik 1974, pp. 32 - 35) according to tables of the BASF Computer Center.
The particle size was determined in the Department of Toxicology of BASF Aktiengesellschaft in accordance with mathematical and graphical methods of evaluating particle measurements (Silverman, L.: Particle Size Analysis in Industrial Hygiene, 1971, pp. 235-259).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.5 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: No mortality.
Mortality:
none
Clinical signs:
other: During exposure: substance-colored fur in the region of the head. After exposure: substance-colored fur, partly agitated behavior, after 1 day nothing abnormal detected.
Body weight:
Mean body weight:
Test animals; before start of the study: 307 g (males), 228 g (females); after 7 days: 341 g (males), 241 g (females); after 14 days: 370 g (males), 252 g (females)
Control animals: before start of the study 307 g (males), 230 g (females); after 7 days 340 g (males), 240 g (females); after 14 days 370 g (males), 249 g (females)
The body weight of the animals showed no adverse effects in comparison with that of the control.
Gross pathology:
Sacrificed animals: no abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met