Registration Dossier

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: acceptable publication which meets basic scientic principles; basic data on expermimental design are given.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VII
Author:
Smyth, HF; Carpenter, CP; Weil, CS; Pozzani UC; Striegel JA; Nycum, JS
Year:
1969
Bibliographic source:
Amer. Ind. Hyg. Assoc. J. 30 (1969), 470
Report Date:
1969
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth, HF; Carpenter, CP; Weil, CS; Pozzani UC; Striegel JA
Year:
1962
Bibliographic source:
Amer. Ind. Hyg. Assoc. J. 23 (1962), 95
Report Date:
1962

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
non-fasted animals, limited reporting
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- name of test material as cited in study report: 2-Norbornene
- no further information on test substance

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals and environmental conditions:
Test Animals
Source: no data
Weight at initiation of study: 90-120 g
Age: 4-5 weeks
No fasting before commencement of study
housing: no data
acclimatation: no data
Diet and Water ad libidum

environmental conditions:
no data on humidity, temperature, airchange or lightning conditions.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
At least 4 dose levels in a logarithmic scale differing by a factor of 2. Individual doses not specified
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
observation period following administration:14d (no data on frequency and weighing)
examinations performed: no data
Necropsy performed: no data

Statistics:
LD50 values were calculated according to the method of Thompson (1947, Bacteriol. Rev. 11, 115) using the tables of Weil. (1952, Biometrics 8, 249).
The limits of +/- 1.96 standard deviations are presented.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
11 mL/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
9 577 mg/kg bw

Any other information on results incl. tables

Fiducial range of LD50 (presented as +/- 1.96 standard deviations) was 7.0 - 18.3 ml/kg b.w. corresponding to 6094 - 1593 mg/kg b.w.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of Norbornene was determined to be 11 ml/kg b.w. corresponding to 9577 mg/kg b.w.
Executive summary:

The acute oral toxicity of Norbornene was determined in groups of 5 male Carworth-Wistar rats, each receiving an oral dose of the test substance by gavage. Dosage range was spaced in a logarithmic spacing of a factor 2. The observation period was 14d. The LD50 was determined with a range of +/-1.96 standard deviations according to the calculation method of Thomson (1947). Overall the study was conducted similar to OECD 401 (retracted)

The acute oral LD50 was 9577 mg/kg b.w. in male rats (Smyth, 1969)