Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent

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:
Signs of toxicity related to dose levels:
There were no deaths and no systemic response to treatment
in any animal.
Body weight:
During Days 8 to 15, a low bodyweight gain was recorded for one female (No. R7). All other animals were considered to have achieved satisfactory bodyweight gains throughout the study. The low bodyweight gain in this individual was considered to be within the normal variability limits for female rats as the individual recorded good weight gain during the period Days 1 to 8, this was not considered to be of toxicological importance.
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.