Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21.08.2007 - 17.10.2007
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Formula: C12H14ClN5O4
Appearence: White to pale yellow solid
Expiry date: 31 December 2007

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)IGS BR.
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: A suspension in an aqueous solution of 0.1% Na- carboxymethylcellulose was used.
Doses:
limit test 2000 mg/kg
No. of animals per sex per dose:
2 groups with 3 animals; in total 6 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No toxic signs were found at animal observation during the
entire observation period.


A body weight gain in 5/6 animals in both weeks p.a. was
noticed, but no body weight gain in 1/6 animals in the 2nd
week p.a.
Gross pathology:
Effects on organs:
No findings were noted at post mortem examination.

Any other information on results incl. tables

Findings in life and post mortem indicate no toxic effects present.

Presence of signs in life: no signs

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

According to REGULATION (EC) No 1272/2008 (CLP) "Fam-stage-1" does not require classification for acute oral toxicity.