Carbonic acid, 4-nitrophenyl 5-thiazolylmethyl ester, hydrochloride (1:1)

Acute Toxicity: oral

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

Test material information

Constituent 1

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-yl)methyl carbonate 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:

other: 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.

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.