Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug. 21, 1981 to Sept. 7, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 with acceptable restrictions (non-GLP, low number of rats).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
Annex: Inhalation Hazard Test
Deviations:
yes
Remarks:
only 6 animals instead of 10
GLP compliance:
no
Test type:
other: Inhalation Hazard Test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 97.5%
- Impurities (identity): Formamide
- Physical state: liquid
- Storage condition of test material: refrigerator

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Wiga, Sulzfeld, Germany
- Age at study initiation: 7-10 weeks
- Weight at study initiation: 180-250 g
- Housing: Wire mesh cage (Becker, D III), 3 animals/cage
- Diet: Herilan MRH of EGGERSMANN KG, Rinteln, Germany, in the form of pellets ad libitum
- Water: About 250 ml/cage tap water daily
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 5%
- Photoperiod (hrs dark / hrs light): 12 / 12 (6 .00 - 18 .00 h light, 18 .00 - 6 .00 h dark)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other:
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The test substance was filled to a height of 5 cm in a glass bottle (fritted glass flask, pore-size 90 - 150 µm, diameter 30 mm), and the net weight was determined. A stream of 200 l/h compressed air was supplied to the fritted glass flask containing the product, which had been placed in a water bath maintained at 20 +/- 1°C by a thermostat. The mixture of air and test substance generated in this way was passed through a glass distributor to 6 glass tubes in which 3 male and 3 female animals had been placed. The emerging mixtures of test substance and air were exhausted. After 30 min, the fritted glass flask was replaced by a new one filled with fresh test substance as described above. This generator was then used for the whole remaining time of the test.

TEST ATMOSPHERE
- Samples taken from breathing zone: no
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
Saturated vapour (The test substance consumed was determined by reweighing the fritted glass flasks).
No. of animals per sex per dose:
3 males and 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Clinical signs of the animals were recorded daily.
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
other: Inhalation Hazard Test
Effect level:
other: saturated vapor
Exp. duration:
7 h
Remarks on result:
other: no mortality observed
Sex:
male/female
Dose descriptor:
LC0
Effect level:
ca. 380 mg/m³ air
Exp. duration:
7 h
Remarks on result:
other: calculated using MW 71.08 and vapour pressure 0.13 hPa
Mortality:
No mortality observed
Clinical signs:
other: During exposure: attempts to escape, wiping of snouts After exposure: normal
Body weight:
Not determined
Gross pathology:
Nothing abnormal detected in the organs

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
No mortality occurred in rats exposed for 7 h to a saturated vapour of the test substance.
Executive summary:

The study is comparable to the inhalation hazard test described in the Annex of OECD Guideline 403 with acceptable restrictions (non-GLP, low number of rats).

Three male and 3 female rats were exposed for 7 h to a saturated vapour of the test substance. Clinical signs during exposure were attempts to escape and wiping of snouts. After exposure no clinical signs were observed. No mortalities occurred during the 14 days of post-exposure observation period. Nothing abnormal was detected in the organs at necropsy.

Conclusion: No mortality occurred in rats exposed for 7 h to a saturated vapour of the test substance.