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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:
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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
2,2-Dimethyl-1,3-propanediol

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
No details; weight data see below

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
Rats exposed for 8 h to a vapour saturated atmosphere.
Vapour was generated by bubbling 200 l/h dry air (no CO2) through the solid substance column (volume ca. 50 ml) of about 5 cm above a fritted glass disc in a glass cylinder. The solid had a temperature of 20°C. No dust generation was visible.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
Saturated vapour. The authors calculated a nominal concentration of 140 mg/m³ (0.21 g substance loss; can be calculated as quotient of the amount of test substance weight loss during the exposure, and the amount of air used during the exposure).
No. of animals per sex per dose:
1) 6 rats tested 8th Aug. 1966 (males and females, no further data)
2) 6 rats tested 9th Aug. 1966 (males and females, no further data)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: observations performed (no details), body weight determined at day 0 and 7
- Necropsy of survivors performed: yes, 7 days after inhalation exposure
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
140 mg/m³ air (nominal)
Exp. duration:
8 h
Remarks on result:
other: saturated vapour at 20°C
Mortality:
No mortality
Clinical signs:
other: No clinical signs
Body weight:
No effects on body weight (measured day 0 and day 7)
Experiment 1: initial total weight of 6 rats was 1693 g, at termination 1707 g
Experiment 2: initial total weight of 6 rats was 1425 g, at termination 1572 g
Gross pathology:
No effects detected at necropsy
Other findings:
No

Applicant's summary and conclusion

Conclusions:
No mortality in male and female rats exposed to saturated vapour at 20°C for 8 h.
Executive summary:

The study is comparable to 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).

12 rats of both sexes (no further data) were exposed for 8 h to saturated vapour generated at a temperature of 20°C. The authors calculated a concentration of 140 mg/m³. No clinical signs were observed and no mortality occurred during the 7 days of post exposure observation period. No effects were detected at necropsy.

Conclusion: No mortality in male and female rats exposed to saturated vapour at 20°C for 8 h.