Carbamic acid ester

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 21 to June 4 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to the guidelines and 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 81-2 (Acute Dermal Toxicity)

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: not indicated
- Weight at study initiation: males 2.3-2.6 kg; females 2.2-2.5 kg
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet: Pelleted Purina Rabbit Chow (ad libitum)
- Water: tap water (ad libitum)
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-27 °C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 4-5 cm2
- % coverage: 10%
- Type of wrap if used: non-permeable adhesive-backed gauze patch wrapped with an elastic cloth

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none,
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

VEHICLE: none

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: bodyweight on day 1, 7 and 14; mortality/clinical signs at 1, 2, 4 and 5 hours after application and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight

Statistics:

NA

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

moderate erythema in one male and one female (up to day 4)
raspy breathing in one male (day 1 and day 6-11)

Body weight:

within normal ranges

Gross pathology:

red foci in lungs of 3 males and 2 females
off-white coloured patches on left lung lobe in 1 female

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 > 2000 mg/kg bw.

Executive summary:

Rabbits (5/sex) were exposed dermally to the test substance at 2000 mg/kg bw for 24 hours. No effects on mortality and body weight were seen during the 14 day observation period. Clinical signs were limited to incidental erythema (2 animales) and raspy breathing (1 animal). Necropsy showed red foci in the lungs of 3 males and 2 females. The LD50 is > 2000 mg/kg bw.