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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
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:
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 levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 6 400 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 6 400 mg/kg bw
Mortality:
No mortality detected in any dose group.
Clinical signs:
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.
Body weight:
no data
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.