Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: with GLP, according to guideline, no deviations
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
TEPIC-G (TGIC) technical grade

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Sprague-Dawley rats (CFY strain, 200-247 gm)
Animals were acclimatized for at least 5 days

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
shaved om the back and the flanks generating a nacked area of 5 x 4 cm (24 hours before treatment). The appropriate amount of dry TGIC was applied to the hair-free skin area which was previously moistened with arachis oil, and surgical gauze was applied to gether with an Elastoplast to generate a semi-occlusive bandage.
Duration of exposure:
Animals were then caged individually in PVC cages, and after 24 hours the bandage was removed and the skin washed with water, then the animals were housed bysex as a group of five.
Doses:
2000 mg/kg bw (single dose)
No. of animals per sex per dose:
5 males & 5 females
Control animals:
not required
Details on study design:
A group of 5 male and 5 female Sprague-Dawley rats (CFY strain, 200-247 gm) was shaved om the back and the flanks generating a nacked area of 5 x 4 cm (24 hours before treatment). The appropriate amount of dry TGIC was applied to the hair-free skin area which was previously moistened with arachis oil, and surgical gauze was applied to gether with an Elastoplast to generate a semi-occlusive bandage. Animals were then caged individually in PVC cages, and after 24 hours the bandage was removed and the skin washed with water, then the animals were housed bysex as a group of five. All animals were observed 1 and 4 hours after dosing and therafter daily once for 14 days.
Statistics:
none

Results and discussion

Preliminary study:
none
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality occurrede (0/10)
Clinical signs:
no clinical signs were recorded which could be attributed to the test substance
Body weight:
Body weight gain was normal in all animals
Gross pathology:
no gross pathological findings were observed

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 if TGIC in rats is > 2000 mg/kg bw
Executive summary:

The dermal LD50 0f TGIC in rats is > 2000 mg/kg bw