2,2-dimethylpropane-1,3-diol

Acute Toxicity: inhalation

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

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

Test material information

Constituent 1

Reference substance name:

2,2-dimethylpropane-1,3-diol

EC Number:

204-781-0

EC Name:

2,2-dimethylpropane-1,3-diol

Cas Number:

126-30-7

Molecular formula:

C5H12O2

IUPAC Name:

2,2-dimethylpropane-1,3-diol

Details on test material:

2,2-Dimethyl-1,3-propanediol

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system 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.