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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
Study period:
5.3.80 - 19.3.80
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study. No analytical purity given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(adopted 1981)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid
EC Number:
279-505-5
EC Name:
6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid
Cas Number:
80584-91-4
Molecular formula:
C21H36N6O6
IUPAC Name:
6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid
Details on test material:
- Physical state: White powder

Test animals

Species:
rat
Strain:
other: RAI f. (SPF) (Ra 25)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: imported from Basle
- Age at study initiation: 5-6 weeks
- Average weight at study initiation: 113 g (males), 102 g (females)
- Fasting before study begin: 18 hours
- Housing: single housing
- Diet: A commercial autoclavable pelleted diet (Labsure CRM rat and mouse nuts), ad libitum.
- Water: Water filtered at 0.45 micron, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5%
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% (w/v)
- Amount of vehicle: 20 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Observations: deaths and clinical symptoms were recorded (at least once daily).
- Necropsy of survivors performed: yes (at the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality and no clinical signs were observed.
Mortality:
No mortality was observed.
Clinical signs:
other: No clinical signs were observed.
Gross pathology:
No abnormalities were seen at terminal autopsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The oral LD50 in rats was determined to be greater than 5000 mg/kg body weight.
Executive summary:

In an oral acute toxicity study pre-dating GLP, five rats per sex were dosed with 5000 mg/kg of the test article in 0.5% CMC by gavage. Following a 14 day observation period all animals were sacrificed and a gross necropsy was performed. No mortality and no clinical signs were observed. No abnormalities were seen at terminal autopsy. As a result, the oral LD50 in rats was determined to be greater than 5000 mg/kg body weight.

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