α,α'-propylenedinitrilodi-o-cresol

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

other: 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)

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).