[1,1'-Biphenyl]-2-carbonitrile, 4'-methyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

not declared

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: The study was provided us by ECHA under the 12 years rule. Available data contain scanty study details: the limited amount of information and the lack of the full study report do not allow a proper reliability assessment.

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

EC 422-310-9 (identity was verified by ECHA while providing us with information in response to our inquiry)

IUPAC Name:

EC 422-310-9 (identity was verified by ECHA while providing us with information in response to our inquiry)

Test animals

Species:

rat

Strain:

other: OFA-SD (J0PS Caw)

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: methylcellulose (0,6%)

Doses:

500, 1000, 2000 mg/kg

No. of animals per sex per dose:

5 animals, males, 500 mg/kg
5 animals, males, 1000 mg/kg
5 animals, males, 2000 mg/kg
5 animals, females, 1000 mg/kg
5 animals, females, 2000 mg/kg

Control animals:

not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 421 mg/kg bw

95% CL:

769 - 3 501

Mortality:

In the groups treated with 1000 mg/kg, 1 death occurred (male). In the groups treated with the highest dose (2000 mg/kg), 4 deaths occurred among males and 4 among females.

Male: 500 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 4
Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 4

Clinical signs:

other: In males treated with the lowest dose (500 mg/kg) and in all amimals (males and females) treated with 1000 mg/kg, marked weakness was observed on Day 1; this effect disappeared on Day 2 in all animals except one male, who was still drowsy on Day 2. In the

Gross pathology:

Necroscopy of animals died during the study showed changes in lungs, gastrointestinal tract and liver. Animals killed at the end of the study did not show at necroscopy any evident change.

Any other information on results incl. tables

LD50: 1421 mg/kg, rat (m)

LD50: > 1000 < 2000 mg/kg, rat (f)

95% Confidence interval: 769 - 3501 mg/kg, rat (m)

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substance should be classified as following for oral acute toxicity:
- DSD: Xn R22
- GHS: Acute tox 4 H302