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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: The study is comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalonitrile
EC Number:
202-044-8
EC Name:
Phthalonitrile
Cas Number:
91-15-6
Molecular formula:
C8H4N2
IUPAC Name:
benzene-1,2-dicarbonitrile
Details on test material:
I- Name of test material (as cited in study report): phthalonitrile
- Analytical purity: pure

Test animals

Species:
rat
Strain:
other: US
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: breeder
- Mean weight at study initiation: 200 +- 23 g (male), 156 +- 8 (female)

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous emulsion with traganth
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5% - 2%

MAXIMUM DOSE VOLUME APPLIED: 16 mL/kg = maximum 3.7 mL per male and 2.6 mL per female animal, respectively
Doses:
50, 100, 125, 160 and 200 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7/14 days
- Frequency of observations and weighing: Weighing was performed only at the beginning of the study. Observation of clinical signs was several times on the day of administration and once daily afterwards except on weekends and on holidays.
- Necropsy of survivors performed: yes
Statistics:
Not performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 125 mg/kg bw
Mortality:
200 mg/kg: 10/10 animals died within 24 hrs after application
160 mg/kg: 8/10 animals died within 24 hrs after application
125 mg/kg: 4/10 animals died within 24 hrs after application
100 mg/kg: 1/10 animals died within 24 hrs after application
50 mg/kg: no mortality
Clinical signs:
other: 100 - 200 mg/kg: directly after application: agitation, accelerated and partly intermittent respiration, clonic convulsions, cry of pain, Straub tail phenomenon ("Morphinschwanz"), oral secretion, ruffled, fluffed fur. Symptoms started to decrease slowly
Gross pathology:
Animals that died
Strong dilatation of the gastrointestinal tract, clear test substance odor, kidney congestion, 1x bloody congested lung, serous or bloody serous smeared snouts in all animals, 1x thorax tissue layers filled with liquid , 4x terminal blood congestion of the lung and the liver, 1x lung edema

Sacrificed animals
Nothing abnormal found

Any other information on results incl. tables

LC0 = 50 mg/kg

Applicant's summary and conclusion

Executive summary:

The study was comparably performed according to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP. Groups of 5 rats per sex and dose were administered 50, 100, 125, 160 and 200 mg/kg of the test substance. The acute LD50 for male and female rats is ca. 125 mg/kg. Clonic convulsions, Straub tail phenomenon, oral secretion, waddling gait and lung edema in one animal that died were observed.

Conclusion

O-phthalonitrile is toxic after acute oral application (R25 following EU classification requirements and Cat. 3 following GHS criteria).