Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
and EEC Annex to Directive 92/69/EEC Part B, Method B.3.
Deviations:
no
GLP compliance:
yes
Test type:
other: single topical application of the test substance

Test material

Constituent 1
Reference substance name:
-
EC Number:
482-330-9
EC Name:
-
Cas Number:
144020-22-4
Molecular formula:
C17H26O
IUPAC Name:
1-[(1E,5Z,9Z)-2,5,10-trimethylcyclododeca-1,5,9-trien-1-yl]ethan-1-one; 1-[(1R)-2,5,10-trimethylcyclododeca-2,5,9-trien-1-yl]ethan-1-one; 1-[(1R)-4,9-dimethyl-12-methylidenecyclododeca-4,8-dien-1-yl]ethan-1-one; 1-[(1S)-2,5,10-trimethylcyclododeca-2,5,9-trien-1-yl]ethan-1-one; 1-[(1S)-4,9-dimethyl-12-methylidenecyclododeca-4,8-dien-1-yl]ethan-1-one

Test animals

Species:
other: Rats (Charles River (UK) Ltd)
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: None, administered as supplied.
Details on dermal exposure:
Very slight erythema was observed in one male (No. R2) and one female (No. R10) during Days 2 to 3 and Days 5 to 8 respectively. The female exhibiting erythema also showed eschar/scabbing on the dose site from Day 4 until Day 12. Desquamation/exfoliation was observed in a further three animals; one male (No. R4) and one female (No. R9) during Days 5 to 6 and one female (No. R8) during Days 7 to 8.
Duration of exposure:
24 hour exposure period
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 animals per sex per dose (2000 mg/kg)
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: There were no deaths and no systemic response to treatment in any animal.
Gross pathology:
Effects on organs:
None observed.
Other findings:
Signs of toxicity (local):
Very slight erythema was observed in one male and one
female during Days 2 to 3 and Days 5 to 8 respectively. The
female exhibiting erythema also showed eschar/scabbing on
the dose site from Day 4 until Day 12.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal dermal dose (LD50) to rats of Trimofix O was demonstrated to be greater than 2000 mg/kg bodyweight.
Trimofix O is in Category 3 according to the EPA Health Effects Test Guidelines OPPTS 870.1000 Acute Toxicity testing EPA 712-C-98-189 August 1998.
Executive summary:

The acute median lethal dermal dose (LD50) to rats of Trimofix O was demonstrated to be greater than 2000 mg/kg bodyweight. Trimofix O is in Category 3 according to the EPA Health Effects Test Guidelines OPPTS 870.1000 Acute Toxicity testing EPA 712-C-98-189 August 1998.