2-chloroethanol

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:

other: The study was performed prior to the implementation of GLP and OECD Guidelines, but meets the principles of an acute oral toxicity study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-chloroethanol

EC Number:

203-459-7

EC Name:

2-chloroethanol

Cas Number:

107-07-3

Molecular formula:

C2H5ClO

IUPAC Name:

2-chloroethan-1-ol

Details on test material:

no further details

Test animals

Species:

rat

Strain:

other: Gassner

Sex:

male/female

Details on test animals or test system and environmental conditions:

Body weight at initiation: females 171-208 g, males 224-288 g
No further details

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous emulsion with traganth

Details on oral exposure:

application volume 10, 10, 8, 6.4, 5 cm³/kg bw
no further details

Doses:

2% (200 µl/kg bw) or 1% (100, 80, 64, 50 µl/kg bw)
corresponding to 240 or 120, 96, 77 60 mg/kg bw (density 1.2)

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: mean terminal body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

77 mg/kg bw

Based on:

test mat.

Mortality:

Data on mortality are presented in the Table below. At the high dose level male and female rats died within 24 h as well as females of the mid dose levels. Most other deaths within 48 h. Females died earlier than males.

Clinical signs:

At 120 and 240 mg/kg bw rats kept calm immediatly after gavage and showed delayed movements; after 1 h prone or side position, apathy, reduced muscle tonus, abnormal respiration, redened eyes, and next day additionally bloody muzzle. Animals died within 48h.
60-96 mg/kg bw: similar clinical signs; the next days the rats showed staggered gait, dyspnea, and clotted muzzles. Survivors showed no clinical signs after 8 days.

Body weight:

Terminal mean body weight in males 244 g and in females 193 g (no data about initial mean weight).

Gross pathology:

Surviving rats without effects.
Rats found dead: dilatated heart, sallow musculature, yellowish liver & kidney, hemorrhagic ulcer of the stomach, intestinal content soft and reddened

Other findings:

no data

Any other information on results incl. tables

Acute toxicity in rats after oral application of 2-chloroethanol

Dose in mg/kg bw	Number of rats which died within
	1 hour	24 hours	48 hours	7 days	14 days
240	0/5m 0/5f	5/5m 5/5f	5/5m 5/5f	5/5m 5/5f	5/5m 5/5f
120	0/5m 0/5f	2/5m 5/5f	5/5m 5/5f	5/5m 5/5f	5/5m 5/5f
96	0/5m 0/5f	1/5m 4/5f	2/5m 4/5f	4/5m 4/5f	4/5m 4/5f
77	0/5m 0/5f	0/5m 1/5f	0/5m 3/5f	1/5m 3/5f	2/5m 3/5f
60	0/5m 0/5f	0/5m 0/5f	0/5m 0/5f	0/5m 0/5f	0/5m 0/5f
f: female; m: males

Applicant's summary and conclusion

Conclusions:

The oral LD50 is 77 mg/kg bw in male and female rats combined.

Executive summary:

The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance).

Groups of 5 male and 5 female rats were gavaged with 1 or 2% aqueous solutions at dose levels of 60, 77, 96, 120, 240 mg/kg bw. The post exposure observation period was 14 days. Clinical signs occurred immediately after gavage: rats kept calm and showed delayed movements, after ca. 1 h prone or side position, apathy, reduced muscle tonus, abnormal respiration, redened eyes, and next day additionally bloody muzzle; no clinical signs were observed later than day 8. At the high dose levels rats died mainly within 4 h, later deaths were also observed. Generally, females died earlier than males. Necropsy revealed dilatated heart, sallow musculature, yellowish liver & kidney, hemorrhagic ulcer of the stomach, intestinal content soft and reddened; no effects were detected in surviving rats. The test substance is toxic if swallowed.

Conclusion: The oral LD50 is 77 mg/kg bw in male and female rats combined.