3,4-dichlorobut-1-ene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study. Adopted according to OECD SIDS (public available peer reviewed source). The original source is available and has been reviewed.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1996

Reference 2

Reference Type:

secondary source

Title:

SIDS Initial Assessment Report for 11th SIAM

Author:

OECD SIDS

Year:

2003

Bibliographic source:

UNEP Publications

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,4-dichlorobut-1-ene

EC Number:

212-079-0

EC Name:

3,4-dichlorobut-1-ene

Cas Number:

760-23-6

Molecular formula:

C4H6Cl2

IUPAC Name:

3,4-dichlorobut-1-ene

Details on test material:

- Name of test material (as cited in study report): 3,4-dichloro-1-butene
- Purities (identity and concentrations): 99.7%

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males: 133 (125-138) g; females (110-122) g

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0, 6.70 w/v% ; 8.04 w/v%, 9.65 w/v%, 11.58 w/v%, 13.89 w/v%, 16.67% w/v%.

Doses:

0 (vehicle), 670, 804, 965, 1158, 1389, 1667 mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Statistics:

Probit analysis.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

943 mg/kg bw

Based on:

test mat.

95% CL:

828 - 1 068

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

946 mg/kg bw

Based on:

test mat.

95% CL:

808 - 1 085

Mortality:

Fatalities were found for both sexes at doses of more than 804 mg/kg.

Clinical signs:

other: Clinical signs of decreased locomotor activity, deep respiration, ptosis, salivation, flaccidity, adoption of a prone position, piloerection and perinasal soiling with nasal discharge were observed in the treated groups.

Gross pathology:

At autopsy, lung enlargement, urine retention and crystalline materials in the urinary bladder, and hemorrhagic black spots in the glandular stomach mucosa were observed in animals.

Any other information on results incl. tables

Table 1. Mortality value of rats treated orally with 3,4 -dichloro-1 -butene in the single dose toxicity test

Sex	Dose(mg/kg)	Number of animals examined	Mortality
Male	0	5	0^a/5^b
	670	5	0/5
	804	5	1/5
	965	5	2/5
	1158	5	5/5
	1389	5	5/5
	1667	5	5/5
Female	0	5	0/5
	670	5	0/5
	804	5	2/5
	965	5	2/5
	1158	5	4/5
	1389	5	5/5
	1667	5	5/5

a: number of animals that died; b: number of animals examined.

Based on the test results, 3,4 -dichlorobut-1 -ene is to be classified as Xn R22 according to DSD-DPD, and Acute Tox 4, according to CLP.

Applicant's summary and conclusion

Executive summary:

MHW, 1996

In an acute oral toxicity study male and Crj:CD(SD) rats were administered orally at doses of 0, 670, 804, 965, 1158, 1389 and 1667 mg/kg (method according to OECD guideline 401) of 3,4 -dichlorobut-1 -ene. The animals were observed for 14 days after administration. Clinical signs of decreased locomotor activity, deep respiration, ptosis, salivation, flaccidity, adoption of a prone position, piloerection and perinasal soiling with nasal discharge were observed in the treated groups. At autopsy, lung enlargement, urine retention and crystalline materials in the urinary bladder and hemorrhagic black spots in the glandular stomach mucosa were observed in animals. Fatalities were found for both sexes at doses of more than 804 mg/kg.

The LD50 values were 943 mg/kg for males and 946 mg/kg for females. Based on the test results, 3,4 -dichlorobut-1-ene is to be classified as Xn R22/20 according to DSD-DPD, and Acute Tox 4, according to CLP (H302, H332, Harmful if inhaled and if swallowed), according to the DSD classification criteria.