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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1970
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
no
Remarks:
study was performed before GLP regulation was established
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3-dihydroxyacetone
EC Number:
202-494-5
EC Name:
1,3-dihydroxyacetone
Cas Number:
96-26-4
Molecular formula:
C3H6O3
IUPAC Name:
1,3-dihydroxyacetone

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Wistar-AF/HAN-EMD-SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
temperature: 25 +/- 2 °C
humidity: 50-55 %

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
intraperitoneal
Doses:
400, 800, 1600, 3200, 6400 mg/kg bw
No. of animals per sex per dose:
Five groups of five (5) Wistar rats (Wistar-AF/HAN-EMD-SPF) per sex were used in this study, i.e. overall 50 animals (25 m and 25 f).
Control animals:
no
Details on study design:
The animals were treated once intraperitoneally using a 5 or 20% aqueous solution of the test item at the following dose levels: 400, 800, 1600, 3200, or 6400 mg/kg BW. The animals were observed for clinical signs and mortality up to 14 days after application. After 14 days all animals were killed and subjected to gross pathological investigation.
Statistics:
None

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 400 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 6 400 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during this study.
Clinical signs:
After administration of 3200 and 6400 mg/kg the animals immediately showed clinical signs including dizziness, tumbling and dyspnoe. After 24 hours these clinical signs were not observed anymore.
Body weight:
Body weight was unaffected.
Gross pathology:
Gross pathology did not reveal any abnormalities.
Other findings:
No other findings

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the LD50 in rats after single intraperitoneal administration of the test item was > 6400 mg/kg body weight.
Executive summary:

The acute toxicity potential of the test item was evaluated following single intraperitoneal administration to male and female Wistar rats at dose levels of 400, 800, 1600, 3200, and 6400 mg/kg bw in water. No deaths were observed in any test item group during the 14-day observation period after administration.

After administration of 3200 and 6400 mg/kg the animals immediately showed clinical signs including dizziness, tumbling and dyspnoe. After 24 hours these clinical signs were not observed anymore. Body weight gain of the treated rats was unaffected. Gross pathology did not reveal any abnormalities in rats treated with the test item up to 6400 mg/kg bw.

Based on the results of this study, the maximum non-lethal dose of the test item in rats after single intraperitoneal administration is >6400 mg/kg bw.