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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:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The report meets basic scientific principles. Study was conducted before establishment of the OECD Test Guideline, but study protocol is in principle similar to OECD TG 403, with acceptable restrictions (limited documentation, no analytical monitoring of test atmosphere concentration). The study is not assignable due to missing determination of the nominal concentration.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
(adopted on 1981, 12th May; Inhalation hazard test described in the Annex)
Deviations:
yes
Remarks:
(No details on animal husbandry, limited documentation, no determination of nominal and analytical concentration).
Principles of method if other than guideline:
BASF-internal standardized test method: the test was performed in principle as described in OECD test guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at 20°C and 50°C. Young adult laboratory rats, 3 per sex, were exposed sequentially to the vapours generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h. The exposure was subsequently repeated in the same manner. No analytical determination of the atmosphere concentrations was performed. If possible, the nominal concentration was calculated as quotient of the amount of test substance weight loss during exposure, and the amount of air used during exposure. Group-wise documentation of clinical signs was performed over a 7 day study period. Body weight of groups was determined before the start of the study and at the end of the observation period.

GLP compliance:
no
Test type:
other: inhalation hazard test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Golpanol SC 9189
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Rats were exposed for 8 h to a vapour saturated atmosphere. Vapour was generated by bubbling 200 L/h air through the liquid substance column (volume ca. 50 mL) of about 5 cm above a fritted glass disc in a glass cylinder. The air pressure was 754 mm Hg. Temperature in the exposure chamber was 20 and 50 °C.

TEST ATMOSPHERE
- Brief description of analytical method used: no analytics performed
- Samples taken from breathing zone: no


Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
Due to missing substance loss, test substance concentration could not be calculated.
No. of animals per sex per dose:
12
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: group wise documentation on working days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: Inhalation Hazard Test
Exp. duration:
8 h
Remarks on result:
other: No mortality.
Mortality:
No mortality observed.

Clinical signs:
No abnormality detected.

Gross pathology:
No abnormality detected.

Applicant's summary and conclusion

Executive summary:

In an acute inhalation hazard test comparable to OECD 403 (adopted on 1981, 12th May; inhalation hazard test), rats were whole body exposed to an atmosphere of saturated vapours of the test substance (analytical purity: not known) at 20 °C for 8 hours (6/dose/sex) or at 50°C for 8 hours (6/dose/sex) and observed for 7 days (BASF XXII/42, 1972). No nominal concentration could be calculated. No mortality and no clinical signs were observed. There were no data about body weight of single animals. In sacrificed animals acute bronchopneumonia was detected in 8/12 animals at 20°C and in 1/8 animals at 50°C.

These studies suggest that exposure ofto highly saturated vapours represents no hazard.