1,3-dichlorobenzene

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: Guideline study with restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

female animals not tested; analytical purity not reported; fasting period not perforemed, acclimation period not performed, LD50 expressed in mL/Kg instead mg/kg; air changes not reported.

Principles of method if other than guideline:

Ten male rats received doses of 100, 200, 500, 1000 or 1500 µl (129, 258, 645, 1290, 1935 mg/kg) of undiluted 1,3-dichlorobenzene per gavage. During the post-observation period of 14 days, mortality, weight and clinical signs were registered.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dichlorobenzene

EC Number:

208-792-1

EC Name:

1,3-dichlorobenzene

Cas Number:

541-73-1

Molecular formula:

C6H4Cl2

IUPAC Name:

1,3-dichlorobenzene

Details on test material:

IUCLID4 Test substance: no data
- Name of test material (as cited in study report): m-dichlorobenzene 99
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: 176 g
- Housing: Makrolon cages type III
- Diet (e.g. ad libitum): Altromin R 1324 (Altromin GmbH, Lage, Germany) ad libitum
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5 °C
- Humidity (%): 60 ± 5%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light (artificial lighting from 7 a.m. to 7 p.m)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:


DOSAGE PREPARATION (if unusual):


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

MAXIMUM DOSE VOLUME APPLIED:


DOSAGE PREPARATION (if unusual):


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

0.1, 0.2, 0.5, 1.0, 1.5 mL/kg (129, 258, 645, 1290, 1935 mg/kg)

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During the observation period the animals were examined twice a day (once a day during the weekend and holidays). The animals were individually weighed at the time of the application and at the end of the 14-day observation period.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight.

Statistics:

The calculation of LD50 with the confidence interval was carried out with the program Probit-Analysis according to Fink and Hund (Arzneim.-Forsch. 15: 1965, 624).

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 580 mg/kg bw

Mortality:

The deaths occurred from the 2nd to 7th day of the experiment.

Clinical signs:

other: 0.2-0.5 mL/kg: necrosis, hair loss, tears. 0.5-1.5 mL/kg: bloodily eyes and nose.

Any other information on results incl. tables

 The calculated LD50 was 0.45mL/kg (580 mg/kgbw). The slope of the Probit regression line (Probitslope factor) showed a value of b = 3.47.The dose of 0.1 mL/kg bw was without symptoms.

  

		Toxicologic results
Dosis mL/kg	Sex	Dead animals	Symptoms	Amount of animals
0.1	male	0	0	10
0.2	male	2	10	10
0.3	male	4	10	10
1.0	male	9	10	10
1.5	male	10	10	10

 

 Signs of intoxication were: narcosis, hair loss, lacrimation, bloody eyes and nose

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Executive summary:

An acute oral toxicology analysis was carried out with 1,3-dicholorobenzene in male rats.

Animals were administered by gavage with 0.1, 0.2, 0.5, 1.0, 1.5 mL/kg (129, 258, 645, 1290, 1935 mg/kg) of 1,3-dichlorobenzene with a method similar to OECD guideline 401 with deviations (female animals not tested; analytical purity not reported; fasting period not perforemed, acclimation period not performed, LD50 expressed in mL/Kg instead mg/kg; air changes not reported).

 

The calculated LD50 for male rats was 0.45 mL/kg (580 mg/kg) bw (b=3.47).

On the basis of these results 1,3-dichlorobenzene is classified as Xn R22, harmful if swallowed according to EU classification and Acute Tox. Cat 4, H302 according to GHS classification.

 

The following symptoms of poisoning were observed: narcosis, tears, hair loss, bloodily eyes and nose.