3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate

Endpoint summary

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:

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.

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