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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:
Mar 17 - Jun 14, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterize

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
92/69/EEC
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
414-490-2
EC Name:
-
Cas Number:
154212-59-6
Molecular formula:
C11H9ClN2O5S
IUPAC Name:
4-nitrophenyl 1,3-thiazol-5-ylmethylcarbonate hydrochloride

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Portage, MI
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: 114 to 145g
- Fasting period before study: Overnight
- Housing: Individual stainless steel ventilated hanging cages
- Diet: Certified Rodent Chow® ad libitum
- Water: tap water ad libitum
- Acclimation period: 6 days before study

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 71 - 72
- Humidity (%): ambient
- Photoperiod (hrs dark / hrs light):12hr daily light cycle

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.2 % hydroxypropylmethyl cellulose (HPMC)
Details on oral exposure:
Using all available information on the toxicity of the test material, 2000 mg/kg was chosen as single dose.
dose volume: 10 ml/kg
Doses:
dose level: 2000 mg/kg
No. of animals per sex per dose:
5 females/males per dose
Control animals:
no
Details on study design:
5 rats/sex were administered Abbott-87439 hydrochloride orally one time.
The day of treatment was designated Day 0.
All animals were observed frequently on the day of treatment and daily for at least 13 days after treatment for a total of 14 days. Daily observations included signs of toxicity in addition to lethality.
Animals were weighed on a weekly basis.
2 weeks after treatment all surviving rats were euthanized and necropsied.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were 2 deaths. 1 female on day 5 and 1 female on day 6
Clinical signs:
Signs of systemic toxicity noted:
Decreased activity- males; 1 on day 9, Females; 1 on day 2, 2 on day 4, 1 on day 5 and 1 on day8
Squinting: 1 female on day 1 and 1 on day 5.
Dyspnea: 1 female on day 2, 1 on day 4 and 1 on day 5.
Body weight:
No treatment-related effects on body weight were apparent during weeks 1 or 2 of the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 value of the test material in male and female rats was determined to be greater than the limit dose administered to animals in this study, 2g/kg.bodyweight.