2-ethylhexyl chloroformate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Limited documentation (e.g. only mean body weights are reported) and pre-GLP/pre-OECD TG.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Limited documentation (e.g. only mean body weights are reported), pre-GLP, pre-OECD TG.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl chloroformate

EC Number:

246-278-9

EC Name:

2-ethylhexyl chloroformate

Cas Number:

24468-13-1

Molecular formula:

C9H17ClO2

IUPAC Name:

2-ethylhexyl carbonochloridate

Details on test material:

- Name of test material (as cited in study report): 2-Ethylhexylchlorformiat (2-ethylhexylchloroformate)
- Physical state: liquid
- Analytical purity: 99%
- Impurities (identity and concentrations): phosgene and Di-2ethylhexylcarbonate
- Storage condition of test material: dry, cool, in glas containers
- Sability under storage conditions > 2 years

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hageman + Wiga, Ottobrunn (Germany)
- Weight at study initiation: 211 g (male); 175 (female)
- Fasting period before study: 15-20 h
- Diet (e.g. ad libitum): Herilan MRH-Haltung; H. Eggemann KG

ENVIRONMENTAL CONDITIONS
Not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 4.3; 9.3; 20.0; 52.2; 92.8; 100 %

MAXIMUM DOSE VOLUME APPLIED: 2ml/animal

Doses:

215; 464, 1000, 2610, 4640, 5000, 6810, 8250 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 day of applicaion, 7 days after application and 13 days after application (on day before termination of the study). Observation of clinical signs was several times on the day of administration and once daily afterwards with the except on weekends and on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs,

Statistics:

The LC50 value was analyzed according to the Probit analysis of Finney (1971) using a computer program.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 420 mg/kg bw

95% CL:

4 913 - 6 050

Mortality:

No animal died at doses up to 2610 mg/kg bw. All animals died at the highest dose group. Most deaths occurred within 2 days after dosing, and all occured within 7 days. See table below for dose specific data.

Clinical signs:

other: Minor symptoms were noted in the animal groups at 215, 464, and 1000 mg/kg bw. In animals 2610, 4640, and 5000 mg/kg bw signs of toxicity included apathy, dyspnea, staggering, tremor, ruffled fur, exophthalmus, and poor general state. Animals at 6810 an

Gross pathology:

Animals that died:
heart: congestion; lung: extended, pulmonary emphysema;
stomach: cases of gastric corrosion (leather-like mucosa);
liver: cases of grayish increased lobular periphery.

Sacrificed animals:
No findings in animals at 215 - 2610 mg/kg bw.
In animals at 4640 - 6810 mg/kg bw wall of forestomach thickened; some cases of diverticle formation.

Any other information on results incl. tables

Mortality after 14 days

Dose (mg/kg)	Males dead/exposed	Female dead/exposed
215	0/5	0/5
464	0/5	0/5
1000	0/5	0/5
2610	0/5	0/5
4640	1/5	1/5
5000	1/5	2/5
6810	4/5	5/5
8250	5/5	5/5

Applicant's summary and conclusion

Conclusions:

2 -ethylhexylchloroformate is of low toxicity after oral uptake.

Executive summary:

The study is according to OECD 401 with acceptable restrictions mostly due to limited documentation (e.g. only mean body weights are reported), pre-GLP, pre-OECD TG. Male and female Sprague Dawley rats were dosed 215; 464, 1000, 2610, 4640, 5000, 6810, 8250 mg/kg 2 -ethylhexylchloroformate. No animal died at doses up to 2610 mg/kg bw. All animals died at the highest dose group. Most deaths occurred within 2 days after dosing, and all occured within 7 days. The oral LD50 value is 5420 mg/kg bw.

Minor symptoms were noted in the animal groups up to1000 mg/kg bw. At higer doses poor general state, staggering, tremor, ruffled fur, exophthalmus, dyspnea and apathy up to loss of cornea reflexes were observd.

Conclusion: 2-ethylhexylchloroformate is of low toxicity after oral uptake.