Registration Dossier

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: Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions (partly limited documentation; post exposure observation period 7 days; low number of rats)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
Annex of the Guideline
Deviations:
no
GLP compliance:
no
Test type:
other: Inhalation Hazard Test
Limit test:
no

Test material

Constituent 1
Reference substance name:
Stearic acid chloride
IUPAC Name:
Stearic acid chloride
Details on test material:
- Name of test material (as cited in study report): Stearinsäurechlorid
- Physical state: liquid
- Analytical purity: 98 %
- pH: acidic
- melting point: 7,3

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 534 g (group 1, mean male), 440 g (group 1, mean female), 490 g (group 2; mean male), 485 g (group 2; mean female)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Rats exposed for 8 h to a vapour saturated atmosphere at 20 °C. Vapour was generated by bubbling 200 l/h dry air (no CO2) through the liquid substance column (volume ca. 50 ml) of about 5 cm above a fritted glass disc in a glass cylinder.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
vapour saturated atmosphere at 20 °C (vapor pressure < 1mbar at 20 °C)
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: weighing at beginning and at temination of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Exp. duration:
8 h
Remarks on result:
other: saturated vapor
Mortality:
no mortality occurred
Clinical signs:
other: attempts to escape bloody discharge from eyes and nose
Body weight:
Mean body weight
group 1 male: 584 g (beginning), 679 g (termination)
group 1 female: 440 g (beginning), 534 g (termination)
group 2 male: 490 g (beginning), 607 g (termination)
group 2 female: 485 g (beginning), 594 g (termination)
Gross pathology:
nothing abnormal detected

Applicant's summary and conclusion

Executive summary:

Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981).

6 rats per sex were exposed sequentially to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder. No death occurred when animals are exposed to a saturated atmosphere of stearoyl chloride for 8 h. The inhalation of a saturated atmosphere represents no acute hazard.

Conclusion

No death occurred when animals are exposed to a saturated atmosphere of stearoyl chloride for 8 h. The inhalation of a saturated atmosphere represents no acute hazard.