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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
p-dichlorobenzene, lot: 08146-P
content 99.9 %
Paradichlorobenzene was prepared as a 60% paste in destilled water and administered at a volume of 3.3 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: 7-10 weeks
- Weight at study initiation: 202-251 g
- Fasting period before study:
- Housing: individually
- 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

Type of coverage:
other: gauze which was held in place with an impermeable dressing encircled firmly around the trunk.
Vehicle:
water
Details on dermal exposure:
To the clipped back of rats the testsubstance was applied as paste and covered by gauze which was held in place by an impermeable dressing encircled firmly around the trunk for 24 hours.
Duration of exposure:
24 hours exposure period.
Doses:
single dermal dose of 2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
no
Details on study design:
To the clipped back of rats the testsubstance was applied as paste and covered by gauze which was held in place by an impermeable dressing encircled firmly around the trunk for 24 hours. Afterwards the dressing was removed and the treated area of the skin was washed with warm water and blotted dry. the observation period was 14 day. then all animal were sacrificed and macroscopically examined.
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 clinical signs of systemic reaction to treatment, no dermal changes or irritation responses, no animal died
Mortality:
no deaths following a single dermal dose of Paradichlorbenzene at 2,0 g/kg bodyweight.
Clinical signs:
no clinical signs of systemic reaction to treatment.
no dermal changes or irritation responses.
Body weight:
see table: in any other information on results
Gross pathology:
Terminal autopsy findings were normal

Any other information on results incl. tables

   Bodyweight (g) at Day    

 Sex

 1 15 

 Male

 232

282 329 
  250  316  396 
   249 316  386 
   251 316  380 
  250 320  385 

 Female

206  240  284 
   250 275  290 
   202 232  255 
   206 236  260 
   250 286  325 

Applicant's summary and conclusion

Executive summary:

In a study according OECD Guideline 402 (Acute Dermal Toxicity) and GLP acute dermal toxicity was tested by applying 2000 mg/kg bw as paste to the back of male and female rats for 24 hours. No clinical signs of systemic reaction to treatment and no dermal changes or irritation responses were observed. No animal died during the 14 day observation period.

The acute lethal dermal dose of paradichlorobenzene to rats was found to be greater than 2000 mg/kg bodyweight .