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: 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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

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.