2,2-dimethylpropane-1,3-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; post exposure period 7 days [but no later deaths expected]; no data about body weight)

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 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

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:

Body weight at initiation: females 136-239 g, males 185-264 g
No further deails.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

2 (200 mg/kg bw), 16 (1600 mg/kg bw), 30% (3200 & 6400 mg/kg bw) solution in water; vehicle: aqua dest; application volume 10, 10, 13.3, 21.3 ml/kg bw, respectively; no data about fasting prior to application.

Doses:

200, 1600, 3200, 6400 mg/kg bw in males and females

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

no further details

Statistics:

LD50 calculated (no details)

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 6 400 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 6 400 mg/kg bw

Mortality:

No mortality detected in any dose group.

Clinical signs:

other: Clinical signs occurred a few minutes after gavage in the high dose group: rats kept calm, slightly accelerated respiration; staggered gait, atony, apathy, and narkosis; no clinical signs during the following 7 days.

Gross pathology:

No treatment related effects.

Other findings:

no data

Applicant's summary and conclusion

Conclusions:

In male and female rats the oral LD50 > 6400 mg/kg bw.

Executive summary:

The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; post exposure period 7 days [but no later deaths expected]; no data about body weight).

Groups of 5 male and 5 female rats were gavaged with 2, 16, or 30% aqueous solutions at dose levels of 200, 1600, 3200, 6400 mg/kg bw. The post exposure observation period was 7 days. Clinical signs occurred a few minutes after gavage: rats kept calm, slightly accelerated respiration; staggered gait, atony, apathy, and narkosis; no clinical signs were observed during the following 7 days. No mortality was detected at any dose level. The test substance is practically non-toxic.

Conclusion: In male and female rats the oral LD50 > 6400 mg/kg bw.