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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Dec 1998 to Jun 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
p-phenylbenzonitrile
EC Number:
220-860-2
EC Name:
p-phenylbenzonitrile
Cas Number:
2920-38-9
Molecular formula:
C13H9N
IUPAC Name:
biphenyl-4-carbonitrile
impurity 1
Chemical structure
Reference substance name:
p-phenylbenzaldehyde
EC Number:
221-742-3
EC Name:
p-phenylbenzaldehyde
Cas Number:
3218-36-8
Molecular formula:
C13H10O
IUPAC Name:
biphenyl-4-carbaldehyde
impurity 2
Reference substance name:
unknown
IUPAC Name:
unknown
Test material form:
solid: bulk
Specific details on test material used for the study:
Batch FH III/TVT 281098

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
age 8 weeks male/12 weeks female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
200mg/kg: 2000mg/kg
No. of animals per sex per dose:
3 per dose per sex
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50 cut-off
Effect level:
ca. 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
piloerection in all animals
sedation in the high dosed males and 2/3 females abnormal posture in a singel case
huchered posture in all high dosed animals closed eyes ni all high dosed males and chromodaccryorrhoie in 1/3 high dosed females.
Body weight:
Body weight an body weigh gain was in conspicuous in all males and females. in one female of each dose group (200 and 2000mg/kg) body weight loss or a markedly lower body weight gain was noted in the second week.
Gross pathology:
all animals were normal at the post mortem examination

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
4-Phenylbenzonitrile does not have to be classified as harmfull according to GHS
Executive summary:

4-Phenylbenzonitrile does not have to be classified as harmfull according to GHS