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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: Body responsible for test
Title:
Unnamed
Year:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-450-9
EC Name:
-
Cas Number:
294-90-6
Molecular formula:
C8H20N4
IUPAC Name:
1,4,7,10-tetraazacyclododecane
Test material form:
not specified
Details on test material:
- Substance name: 1,4,7,10-tetraazacyclododecane

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl: (WI) BR
Sex:
male/female

Administration / exposure

Vehicle:
other: NaCl/Polyoxyl-50-stearate (Myrj53)
No. of animals per sex per dose:
Preliminary sighting study: 3 (male)Preliminary sighting study: 3 (female)Main study: 3 (male)Main study: 3 (female)
Details on study design:
Preliminary sighting study:At 2000 mg/kg 6 of 6 animals died.Main study:200 mg/kg: no abnormal findings occurred

Results and discussion

Preliminary study:
Species/strain: rat, Wistar2000 mg/kg bw: Evident toxicity: Y; Mortality: Y500 mg/kg bw: not administered50 mg/kg bw: not administered5 mg/kg bw: not administered<5 mg/kg bw: not administered200 mg/kg bw: Evident toxicity: N; Mortality: NObservations:2000 mg/kg: reddish rhinorrhea and silorrhea in one maleafter 30 min of treatment, additionally slight apathy,incomplete eylid closure, ruffled fur, and abnormalbreathing from ca. 6h after treatment in all males, femaleswithout clinical findings.
Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
>= 200 mg/kg bw
Effect level:
200 mg/kg bw
Remarks on result:
other: No. with evident toxicity: 0; No. of deaths: 3; No of animals used:3
Effect level:
200 mg/kg bw
Remarks on result:
other: No. with evident toxicity: 3; No. of deaths: 3; No. of animals used: 3
Effect level:
2 000 mg/kg bw
Remarks on result:
other: No. with evident toxicity: 0; No. of deaths: 0; No. of animals used: 3
Clinical signs:
other: 2000 mg/kg: males: reddish rhinorrhea and silorrhea in one animal after 30 min of treatment, additionally slight apathy, incomplete eylid closure, ruffled fur, and abnormalbreathing from ca. 6 h after treatment in all animals, all animals dead after 24 h
Gross pathology:
2000 mg/kg (males and females): necropsy revealed multifocal reddening in stomach, paleness of spleen, discoloration in lung lobes200 mg/kg (males and females): no abnormal findings

Applicant's summary and conclusion

Interpretation of results:
other: Harmful
Remarks:
Migrated information criteria interpretation of results: EU
Conclusions:
Test substance in Wistar rats has a discriminating dose of >=200 mg/kg bw.
Executive summary:

The acute toxicity of test substance was performed according to the OECD 423 (1996) Guideline under GLP conditions.

For this limit test type, an initial concentration of 200 mg/kg bw of tst substance in vehicle ( NaCl/Polyoxyl-50 -stearate (Myrj53)) were administered orally to 3 male and 3 female Wistar rats. Due to the 100% mortality of the initial dose, for the main test a concentration of 200 mg/kg bw concentration was used. The effects of test substance on animals were evaluated using the clinical signs, gross pathology, body weight and necropsy.

Test substance in Wistar rats has a discriminating dose of >=200 mg/kg bw.