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Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
chronic toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from QSAR database
GLP compliance:
not specified
Species:
rat
Strain:
other: F344/N;Crl:CD(SD)BR;Fischer;Sprague-Dawley;F344;Crj:CD(SD);Wistar;COBS/CD
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
98 days
Remarks:
Doses / Concentrations:
0.00, 10.00, 30.00, 100.00, 300.00, 1000.00
Basis:
no data
Control animals:
not specified
Dose descriptor:
LOEL
Effect level:
710.363 other: mg/kg
Based on:
test mat.
Sex:
male/female
Critical effects observed:
not specified

The prediction was based on dataset comprised from the following descriptors: "effect LOEL"
Estimation method: Taking average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain

(("a" and ("b" and ( not "c") ) ) and ("d" and "e" ) )

Domain logical expression index: "a"

Similarity boundary:Target: C(C)(=O)OC1C2C3C(C=CC3)C(C2)C1
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Group 14 - Carbon C AND Group 16 - Oxygen O by Chemical elements

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Group 1 - Alkali Earth Li,Na,K,Rb,Cs,Fr OR Group 15 - Nitrogen N OR Group 15 - Phosphorus P OR Group 16 - Sulfur S OR Group 17 - Halogens Br OR Group 17 - Halogens Cl OR Group 17 - Halogens F,Cl,Br,I,At by Chemical elements

Domain logical expression index: "d"

Parametric boundary:The target chemical should have a value of log Kow which is >= 2.61

Domain logical expression index: "e"

Parametric boundary:The target chemical should have a value of log Kow which is <= 3.03

Conclusions:
The LOEL value observed was 710.3632 mg/kg in male/female rat by oral exposure in a chronic study conducted with 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate.
Executive summary:

The LOEL value observed was 710.3632 mg/kg in male/female rat by oral exposure in a chronic study conducted with 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate. The LOEL value was obtained using the QSAR estimation model for 98 days on the species rat. The study was observed both on male and female rat species.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LOAEL
Study duration:
chronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from QSAR database
GLP compliance:
not specified
Species:
rat
Strain:
other: Wistar;F344;Charles River;F344/N
Sex:
male/female
Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
6hr/day
Remarks:
Doses / Concentrations:
0.00, 75.00, 225.00, 750.00 6hr/day exposure
Basis:
no data
Control animals:
not specified
Dose descriptor:
LOEL
Effect level:
115.575 other: mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Critical effects observed:
not specified

The prediction was based on dataset comprised from the following descriptors: "effect LOEL"
Estimation method: Taking average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain

(("a" and "b" ) and ("c" and "d" ) )

Domain logical expression index: "a"

Similarity boundary:Target: C(C)(=O)OC1C2C3C(C=CC3)C(C2)C1
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "b"

Similarity boundary:Target: C(C)(=O)OC1C2C3C(C=CC3)C(C2)C1
Threshold=60%,
Dice(Atom pairs)

Domain logical expression index: "c"

Parametric boundary:The target chemical should have a value of log Kow which is >= 1.12

Domain logical expression index: "d"

Parametric boundary:The target chemical should have a value of log Kow which is <= 4.2

Conclusions:
The LOEL value observed was 115.5753 mg/kg bw/day in male/female rat by inhalation route in a subacute study conducted with 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate.
Executive summary:
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The LOEL value observed was 115.5753 mg/kg bw/day in male/female rat by inhalation route in a subacute study conducted with 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate. The LOEL value was obtained using the QSAR estimation model on the species rat. The study was observed both on male and female rat species.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: dermal
Adequacy of study:
other information
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The LOEL value observed was 710.3632 mg/kg in male/female rat by oral exposure in a chronic study conducted with 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate. The Lowest observed level value was obtained using the QSAR estimation model for 98 days on the species rat. The study was observed both on male and female rat species.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
The LOEL value observed was 115.5753 mg/kg bw/day in male/female rat by inhalation route in a subacute study conducted with 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate. The LOEL value was obtained using the QSAR estimation model on the species rat. The study was observed both on male and female rat species.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
The repeated dose toxicity via dermal route does not need to be considered as the acute toxicity for dermal route is non toxic. The non toxic natue of 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate in dermal category can be observed in end point 7.2.3 of the dossier. Since the acute lethal effect of 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate is beyond the toxicity criteria so repeated dose effect for the same substance will also be non toxic.

Justification for classification or non-classification

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