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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,3-dichlorobut-2-ene
- Physical state: yellow-brown liquid
- Analytical purity: 99.1%
- Stability under test conditions: The analytical studies on the stability of the test substance in medium showed that 1,3-dichlorobut-2-ene in the concentration range 10-200 mg/mL and over the period of use was stable. Stability is therefore assumed also for the slightly deviating concentration of 9 mg/mL in the lowest dose, stability under these conditions.
- Storage condition of test material: at room temperature.

Test animals

Species:
rat
Strain:
other: WISW (SPF Cpb)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany.
- Age at study initiation: about 8 (males) and 10 (females) weeks old according to their weight.
- Weight at study initiation: 193 g (average weight, males), 170 g (average weight, females).
- Fasting period before study: yes, from about 16 hours before until to 4 hours after the treatment, the food was withdrawn.
- Housing: in groups of 5 animals in Makrolon cages Type III.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 10
- Air changes (per hr): 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1,2-Propandiol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 9 mg/mL, 20 mg/mL, 44.8 mg/mL, 100 mg/mL
- Amount of vehicle (if gavage): 10 mL kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg


Doses:
90, 200, 448, 1000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not necessary
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: general conditions and clinical signs were observed twice per day (once a day during weekends and public holidays).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight.
Statistics:
LD50 was derived according to Spearman-Kärber.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
414 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
300 mg/kg bw
Based on:
test mat.
Mortality:
MALES
90 mg/kg bw: no fatalities were observed;
200 mg/kg bw: no fatalities were observed;
448 mg/kg bw: 3/5 animals (60%) died during a range period between 4 hours and 1 day;
1000 mg/kg bw: all animals died (100%) within 1 hour from the application.

FEMALES
90 mg/kg bw: no fatalities were observed;
200 mg/kg bw: no fatalities were observed;
448 mg/kg bw: 5/5 animals (100%) died during a range period between 4 hours and 1 day;
1000 mg/kg bw: all animals died (100%) within 1 hour from the application.
Clinical signs:
The symptoms after dosing of 200 to 1000 mg/kg were ruffled fur and sedation. After 1000 mg/kg all animals showed salivation. At the dose of 90 mg/kg per body weight there were no symptoms in either male or female rats.
Body weight:
Three rats in the 200 mg/kg group and one male in the 448 mg/kg dose group had a small weight loss.
Gross pathology:
The pathology of animals that died (during the experiment) showed very congested vessels in the stomach as well as very reddened mucous membranes. The small intestine was also much reddened. After the 1000 mg/kg dose, the stomach was filled with a clear fluid, and after the 448 mg/kg dose it was filled with a thin watery food mush. The pathology of the animals at the end of the experiment showed that in males of the 448 mg/kg group the liver was grown together with the stomach and peritoneum. All of the other animals were normal.

Any other information on results incl. tables

Based on the study results the test substance is to be classified as Xn; R22 (Harmful if swallowed) according to DSD-DPD criteria and Acute Tox 3 (H301; Toxic if swallowed) according to CLP criteria.

Applicant's summary and conclusion

Executive summary:

Bomhard (1991)

In an acute oral toxicity study fasted male and female WISW (SPF Cpb) rats were administered 90, 200, 448, 1000 mg/kg bw 1,3-dichlorobut-2-ene. The animals were observed for 14 days after administration. No mortalities occurred at 90 and 200 mg/kg bw in male and female animals. Mortalities occurred in males at 448 and 1000 mg/kg bw (60 % and 100% mortality respectively) and in females at 448 and 1000 mg/kg bw (100% at both doses). The acute oral LD50 was calculated to be 414 mg/kg bw for male animals and 300 mg/kg bw for female animals. The following signs of clinical toxicity were reported: after dosing of 200 to 1000 mg/kg ruffled fur and sedation. After 1000 mg/kg all animals showed salivation. At the dose of 90 mg/kg per body weight there were no symptoms in either male or female rats. Three rats in the 200 mg/kg group and one male in the 448 mg/kg dose group had a small weight loss. The pathology of animals that died during the experiment showed very congested vessels in the stomach as well as very reddened mucous membranes. The small intestine was also much reddened. After the 1000 mg/kg dose, the stomach was filled with a clear fluid, and after the 448 mg/kg dose it was filled with a thin watery food mush. The pathology of the animals at the end of the experiment showed that in males of the 448 mg/kg group the liver was grown together with the stomach and peritoneum. All other animals were normal.

Based on the study results the test substance is to be classified as Xn; R22 (Harmful if swallowed) according to DSD-DPD criteria and Acute Tox 3 (H301; Toxic if swallowed) according to CLP criteria.