sec-butyl chloroformate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

sec-butyl chloroformate

EC Number:

241-475-6

EC Name:

sec-butyl chloroformate

Cas Number:

17462-58-7

Molecular formula:

C5H9ClO2

IUPAC Name:

butan-2-yl carbonochloridate

Constituent 2

Reference substance name:

sec.-Butylchloroformate

IUPAC Name:

sec.-Butylchloroformate

Constituent 3

Reference substance name:

83/282

IUPAC Name:

83/282

Details on test material:

- Name of test material (as cited in study report): sec.-Butylchlorformiat (butyl carbonochloridic acid ester)- Physical state: clear liquid- Analytical purity: ca. 99%- Impurities (identity and concentrations): traces of phosgene, di-sec.-butylcarbonate, 2-chlorobutane, HCl- Expiration date of the lot/batch: end of march 1984- Stability under test conditions: max. 24 h- Storage condition of test material: < 5°C

Test animals

Species:

rabbit

Strain:

Vienna White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Gaukler, Offenbach, D- Mean weight at study initiation: males 2.65 kg; females 2.56 kg- Diet (e.g. ad libitum): Ovator Solikanin 4mm, Muskator, Duesseldorf, D- Water (e.g. ad libitum): tap water- Acclimation period: at least 1 wENVIRONMENTAL CONDITIONS- Temperature (°C): 20 - 24- Humidity (%): 30 - 70- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE- Area of exposure: ca. 101 cm2REMOVAL OF TEST SUBSTANCE- Washing (if done): with warm water

Duration of exposure:

24 hrs

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations and weighing: Weighing was performed at the beginning and on d4, d7 and d14. Observations were performed several times on the day of application and at least once per workday- Necropsy of survivors performed: yes

Statistics:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

not observed

Clinical signs:

Due to the caustic properties servere erythema (partly haemorrhagic) , edema, ulcer and scale formation. Beside this, no abnormalities or syptoms of a sytemic toxicity were observed

Body weight:

The mean body weight of the males and females increased from 2.65 to 2.89 kg and from 2.56 to 2.81 kg, respectively, within the 14 d observation period.

Gross pathology:

Skin: Pronounced incrustation with superficial bloody erosions/ ulcerations; 5- to 8-fold callosity-like thickening. Hyperplasia of the epidermis and of the hair follicle epithelian cells and of the tissue in the region of the corium with clumps of round cells (fibrosis) were found in one male after histopathological examinations.

Applicant's summary and conclusion

Executive summary:

The study is conducted similar to OECD 402 and is reliable without restrictions. Male and female White Vienna rabbits were treated with 2000 mg/kg test substance for 24 hrs under semiocclussive conditions. The acute LD50 of sec.-Butylchlorformate in rabbits is > 2000 mg/kg after dermal application. Mortalities and clinical signs were not observed, but strong irritant effects at the application site.

Conclusion

According to the results of the present study the test substance, sec-Butylchlorformate has to be regarded as practically nontoxic after single dermal application.