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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC-Directive 92/69 B.1-bis.
GLP compliance:
yes
Test type:
fixed dose procedure

Test animals

Species:
other: rat, Wistar strain Crl: (WI) BR

Administration / exposure

Vehicle:
other: Propylene glycol (specific gravity 1.036).
No. of animals per sex per dose:
Preliminary sighting study: 4 (male)
Preliminary sighting study: 4 (female)
Main study: 5 (male)
Main study: 5 (female)
Details on study design:
Preliminary sighting study:
2000 mg/kg: The two males died and the two females were
killed in extremis within 2 hours after dosing.

500 mg/kg: The male and female died within 24 hours after
dosing.

50 mg/kg: No mortality occurred.

Main study:
As no mortality occurred at the dose level of 50 mg/kg in
the preliminary sighting study, the main study was conducted
with a fixed dose of 50 mg/kg body weight administered to
five rats of each sex.

Results and discussion

Preliminary study:
Species/strain: rat, Wistar strain Crl: (WI) BR
2000 mg/kg bw: Evident toxicity: Y; Mortality: Y
500 mg/kg bw: Evident toxicity: Y; Mortality: Y
50 mg/kg bw: Evident toxicity: Y; Mortality: N
mg/kg bw: Evident toxicity: ; Mortality:

Observations:
At 2000 mg/kg (2M/2F tested): spasms (2M/2F); pale skin
(2M); salivation (2M). Males died day 1; females killed in
extremis day 1.

At 500 mg/kg (1M/1F tested): lethargy (1M); spasm (1M/1F);
ventro-lateral recumbency (1M); uncoordinated movements
(1M/1F). Male: died day 2; female: died day 1.

50 mg/kg (1M/1F tested): lethargy: (M/F); hunched posture
(M/F); uncoordinated movements (M/F); piloerection: (M/F).
Secheduled necropsy day 8.

Macroscopic findings:

2000 mg/kg: males: stomach: hemorrhage (glandular mucosa);
thickened, red-brown forestomach; liver: discoloration,
gray-white.

Females: same as males: in addition: red-brown discoloured
lungs and hemorrhage of the left side cortex of the adrenal
glands.


At 500 mg/kg: male: enlarged stomach.

female: dark red discolouration of the glandular mucosa of
the stomach and a thickened forestomach.

At 50 mg/kg: no findings noted.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
50 mg/kg bw
Dose descriptor:
other: 50 mg/kg bw (fixed dose initial)
Remarks on result:
other: No. with evident toxicity: 5; No. of deaths: 0; No. of animals used: 5
Clinical signs:
Signs of toxicity:
Hunched posture and uncoordinated movements were noted in
all animals on day 1.
Gross pathology:
Effects on organs:
No findings.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information