Carbamic acid ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 6 to 20, 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to the guideline under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

report states 81-2

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Royalhart Colony New Hampton NY
- Age at study initiation: not indicated
- Weight at study initiation: males 236-262 g; females 211-239 g
- Fasting period before study: 18 hours
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet Pelleted Purina Rat Chow #5012 (ad libitum)
- Water: tap water (ad libitum):
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-27 °C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 90%

MAXIMUM DOSE VOLUME APPLIED: 1.3 mL

Doses:

5000 mg/kg bw (administered as 90% solution)

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/clinical signs at 1,2,3,4 and 6 hours after application and daily thereafter, body weight on day 1, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and macroscopy

Statistics:

NA

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: it is not clear whether a correction for the purity of the substance was made

Mortality:

None

Clinical signs:

red-brown dry nasal discharge on day 1 in 2 males

Body weight:

within normal ranges

Gross pathology:

lung haemorraghes in all animals (related to the CO2 euthanasia method)
1 female with white patches on the lung

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the substance is > 5000 mg/kg bw

Executive summary:

Rats (5/sex) were exposed by oral gavage to the test substance at 5000 mg/kg bw. No effects on mortality and body weight were seen during the 14 day observation period. Clinical signs were limited to nasal discharge (2 males on day 1) . Necropsy showed haemorraghes in the lungs of all animals. This finding is related to the use of CO2 in the euthanasia procedure The LD50 is > 5000 mg/kg bw.