Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The analogue isobornyl acetate which shares the same functional groups with dextro alpha fenchyl acetate also has comparable values for the relevant molecular properties. A scientific review (peer reviewed). No data on GLP.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1975

Materials and methods

Principles of method if other than guideline:
No data provided on the method.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
EC Number:
204-727-6
EC Name:
Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
Cas Number:
125-12-2
Molecular formula:
C12H20O2
IUPAC Name:
(1S,2S,4S) 1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
Details on test material:
- Name of test material (as cited in study report): Isobornyl acetate
- Molecular formula (if other than submission substance): C12H20O2
- Molecular weight (if other than submission substance): 196.286
- Smiles notation (if other than submission substance): CC(=O)O[C@H]1C[C@@H]2CC[C@@]1(C)C2(C)C
- InChl (if other than submission substance): 1/C12H20O2/c1-8(13)14-10-7-9-5-6-12(10,4)11(9,2)3/h9-10H,5-7H2,1-4H3
- Structural formula attached as image file (if other than submission substance): see Fig.

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
20 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Read-across from an analogue

Any other information on results incl. tables

The data matrix is included in the reporting format attached.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the read-across approach from experimental data on the analogue isobornyl acetate, the dermal LD50 in rabbit is greater than 20000 mg/kg bw
Executive summary:

Based on the read-across approach from the analogue isobornyl acetate, the dermal LD50 of dextro alpha fenchyl acetate in rabbits is greater than 20000 mg/kg bw.