Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further details

Test animals

Species:
rat
Strain:
other: Gassner
Sex:
male/female
Details on test animals 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.