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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented, scientifically acceptable study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Principles of method if other than guideline:
According to BASF-internal standard.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
adipic acid dihydrazide
IUPAC Name:
adipic acid dihydrazide
Constituent 2
Chemical structure
Reference substance name:
Adipohydrazide
EC Number:
213-999-5
EC Name:
Adipohydrazide
Cas Number:
1071-93-8
Molecular formula:
C6H14N4O2
IUPAC Name:
hexanedihydrazide
Test material form:
solid: crystalline
Details on test material:
- Name of the test substance used in the study report: Adipinsaeurehydrazid- Purity: 84%- Physical state/appearance: white, crystalline- Impurities: ca 16% methanol, ca. 120 ppm Hydrazine

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Mean body weight at the start of the study: male animals 266 g, female animals 183 gAge at the beginning of the study: 8 weeksThe animals received Kilba A 343 laboratory diet for rats/mice. 10 mm pellets, Klingentalmühle AG, 4303 Kaiseraugst. Switzerland, and drinking water ad libitum during the observation period.The animals were accommodated in fully air-conditioned rooms in which central air-conditioning guaranteed a range of temperature of 20 – 24 °C and a range of relative humidity of 30 - 70%.The rats were housed in groups of five in D III Wire mesh cages, without bedding and with a light/dark rhythm of 12 hours.

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose/head only
Vehicle:
other: unchanged
Details on inhalation exposure:
INA 20 head/nose inhalation system (glass/steel construction, BASF Aktiengesellschaft, V = 55 L), the animals sit in tubes and their snouts project into the inhalation chamber.A dust/air mixture was generated by means of a vibratory metering device (BASF).The substance to be tested was transformed into a dust aerosol by means of a dust generator, and was passed into the inhalation system.An automatic vibrator was used to generate dust. The concentration was adjusted by varying the apertural width and the amplitude of oscillation of the metering beaker.The following flows were adjusted: 1500 L/h of compressed air through the injector and 1500 L/h of conditioned air as dilution air. The supply air was conditioned via a central air-conditioning unit so that there was a temperature of between 19 and 25 °C inside the exposure equipment.The setting of the exhaust air system was 10% lower than that of the supply air system (excess pressure). This ensured that the mixture of the test substance and air was not diluted by laboratory air to the breathing zones of the animals. In order to analyse the particle size, one sample was collected from each test group no earlier than 30 minutes following the start of the study. Prior to sample collection, the impactor was provided with glass fiber collecting disks and a residual particles filter. It was connected to the pump and the test equipment and a sample (9 L) was collectedThe impactor was disassembled, the collecting disks and the residual particles filter were weighed, the samples obtained were analysed gravimetrically. The contents of the preimpactor were also determined gravimetrically.Test atmosphereMMAD (Mass median aerodynamic diameter) / GSD (geometric st. dev .): 3.90 µm / 2.78 µm.The results from particle size analyses demonstrate a fine dust proportion of 85.4 %.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric determination of the concentration
Duration of exposure:
4 h
Concentrations:
5.3 mg/L
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: The animals surviving the exposure period were observed for 14 days.- Frequency of observations and weighting: The animals' body weights were checked before the start of the study, after 7 days and at the end of the observation period, and were collated in a diagram. The animals were checked for clinical signs on each working day. The lethality was checked daily.- Necropsy of survivors: Subsequent to the 14-day observation period, the animals were sacrificed by means of C02 and subjected to a gross-pathological examination
Statistics:
Yes.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.3 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
None.
Clinical signs:
other: During exposure: attempts to escape at study start. After exposure: none.
Body weight:
No impairment compared with the control group.
Gross pathology:
Sacrificed animals: nothing abnormal detected.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The LC50,4h of adipic acid dihydrazide is >5.3 mg/L.
Executive summary:

Rats were exposed to adipic acid dihydrazide as a dust in a head/nose inhalation system to a concentration of 5.3 mg/L. The animals were checked for clinical signs for 14 days. Subsequent to the 14-day observation period, the animals were subjected to a gross-pathological examination.

No mortality and no relevant clinical signs or lesions at post mortem examination were detected. The LC50,4h >5.3 mg/L.