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: In compliance with current guideline, but individual animal data were not shown

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
5 rats/sex/dose group,  test substance was diluted in polyethylene glycol 400, single application by gavage after rats had fasted for 20-24 hours. Symptoms and mortality were recorded for 14 days. Dead rats and survivors were necropsied and grossly examined by a general inspection of digestive tract, liver, lungs, kidneys, heart and spleen. LD50 was calculated according to the method of Weil (1952).
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: other TS: p-chlorophenyl isocyanate, no data on purity

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
male: 168, 286, 486 and 826 mg/kg bw; female: 58, 99, 168, 286 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Statistics:
LD50 was calculated according to the method of Weil (1952).

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
335 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
138 mg/kg bw
Mortality:
rats (male); deaths/symptoms/no exposed:
168 mg/kg 0/5/5; 286 mg/kg 3/5/5; 486 mg/kg 3/5/5; 826 mg/kg 5/5/5;
rats (female); deaths/symptoms/no exposed:
58 mg/kg 0/5/5; 99 mg/kg 2/5/5; 168 mg/kg 3/5/5; 286 mg/kg 4/5/5;
Clinical signs:
lethargy was the only sign of intoxination preceding death
Body weight:
male (178 to 342 g); female (184 to 240 g)
Gross pathology:
a gross necropsy was conducted with a general inspection of the digestive tract, liver, lungs, kidneys, heart and spleen

Any other information on results incl. tables

RS-Freetext:
Dose        deaths/exposed   time of death     
(mg/kg bw)   male//female     (hours)

   58             // 0/5           // --         
   99             // 2/5           // 3
  168         0/5 // 3/5       --  // up to 24
  286         3/5 // 4/5       2.5 // 2.5
  486         3/5 //           1.5 //
  826         5/5 //           1   //

LD50 value: male: 355 mg/kg bw; female: 138 mg/kg bw

Signs of intoxication were observed in all rats in test and
included lethargy.
Gross necropsy revealed gastrointestinal inflammation in
dead rats; internal organs of survivors appeared normal.

Applicant's summary and conclusion

Executive summary:

5 rats/sex/dose group,  test substance was diluted in polyethylene glycol 400, single application by gavage after rats had fasted for 20-24 hours. Symptoms and mortality were recorded for 14 days. Dead rats and survivors were necropsied and grossly examined by a general inspection of digestive tract, liver, lungs, kidneys, heart and spleen.

LD50 value: male: 355 mg/kg bw; female: 138 mg/kg bw.

Gross necropsy revealed gastrointestinal inflammation in
dead rats; internal organs of survivors appeared normal.

Lethargy was the only sign of intoxination preceding death.