Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only 7 days of observation
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
α,α'-propylenedinitrilodi-o-cresol
EC Number:
202-374-2
EC Name:
α,α'-propylenedinitrilodi-o-cresol
Cas Number:
94-91-7
Molecular formula:
C17H18N2O2
IUPAC Name:
α,α'-propylenedinitrilodi-o-cresol
Details on test material:
- Name of test material (as cited in study report): Keromet MD
- Physical state: liquid
- Analytical purity: ca. 80 %
- Impurities (identity and concentrations): toluene, ca. 20 %

Test animals

Species:
rat
Strain:
other: US-rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 140-234 g, females 115-194 g

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous traganth emulsion
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2, 10, 20 or 30 % (V/V)
Doses:
0.2, 1.0, 1.25, 1.6, 2.5, 3.2, 6.4 ml/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology
Statistics:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 350 mg/kg bw
Based on:
test mat.
Remarks on result:
other: => ca. 1.5 ml/kg in the study report with a purity of ca. 80 %, density used for calculation: 1.13 g/cm3 for 1.2 ml
Mortality:
0.2 ml/kg => no deaths
1.0 ml/kg => 1/10 animals died
1.25 ml/kg => no deaths
1.6 ml/kg => 6/10 animals died
2.5 ml/kg => 8/10 animals died
3.2 ml/kg => all animals died
6.4 ml/kg => all animals died
Clinical signs:
Hunched position, dyspnea, aqueous secretion out of the mouth, blood encrusted eyes and noses, horrent fur, spastic gait. All animals were free of symptoms after 4 days (low dose animals recovered quicker)
Body weight:
not specified
Gross pathology:
Animals that died: blood encrusted eyes, smeared anuses, intestines with test substance smell, inflated stomach, diarrhea. Sacrificed animals at end of study: organs without findings

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the available acute oral studies, the substance is classified Acute toxicity oral Cat 4 (according to CLP).

Categories Display