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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP declaration given but no certificate

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes
Details on test material:
p-dichlorobenzene, lot: 08146-P
content 99.9 %
Paradichlorobenzene was prepared at 20% (w/v) concentration in corn oil and administered at a volume of 10.0 ml/kg.
Stability and absorbtion of the test substance were not determined.

Test animals

Species:
rat
Strain:
other: CFY ( Sprague-Dawley origin)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 103-145 g
- Housing: in groups
- Diet ad libitum
- Water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 54
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Single oral application by gavage as 20% (w/v) concentration in corn oil and administered at a volume of 10.0
Doses:
single dose of 2000 mg/kg bodyweight.
No. of animals per sex per dose:
5 F
5 M
Control animals:
no
Details on study design:
All animals were observed 14 days after dosing and then sacrificed and subjected to macroscopic examination.
Statistics:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no animal died;
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no animal died during the observation period and recovered from unspecific findings (piloerection, hunched posture) by day 3
Mortality:
no animal died
Clinical signs:
Signs of reaction to treatment observed in rats doses orally with paradichlorbenzene:

Signs No.of rats in group of 5 showing signs
Male Female
Pilo-erection 5 5
Abnormal body carriage 5 5
(hunched posture)
Abnormal gait (waddling) 5 5
Lethargy 1 0
Decreased respiratory rate 1 0
Pallor of extremities 1 1
Increased salivation 5 5
Body Tremors 1 1
Prostrate 1 0
Body weight:
Individual bodyweight (g) of rats dosed orally with paradichlorbenzene (dose: 2000mg/kg)

Sex Day 1 Day 8 Day 15
Male 112 192 266
103 178 241
110 188 262
108 158 237
108 180 264
Female
130 184 220
128 184 220
145 191 230
130 172 205
128 190 226
Gross pathology:
Terminal ausopsy findings were normal.

Any other information on results incl. tables

There were no deaths following a single oral dose of paradichlorobenzene at 2000 mg/kg bodyweigt.

Applicant's summary and conclusion

Executive summary:

In a study according OECD Guideline 401 (Acute Oral Toxicity) and GLP 10 male and female rats were tested of aute toxicity receiving 2000 mg/kg bw by gavage. Within 3 hours post application the rats displayed

salivation, piloerection, hunched posture and abnormal gait but recovered within 3 days. No animal died during the 14 day observation period. The acute lethal dose of paradichlorobenzene in rat was found to be greater than 2000 mg/kg bodyweight .