Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study predates GLP and test guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
Test substance applied dermally (occlusive dressing) for 24 hours, dressing removed (site not washed) and rabbits observed for up to 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dantoin DMH
-Physical state: white crystals
-Lot/batch No.: 838668

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Test animals
Source: Marland Breeding Farms, Inc.
Weight at study initiation: 2.0-3.5 kgs
Housing: individual
Diet: ad libitum
Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: saline
Details on dermal exposure:
TEST SITE
- % coverage: 10%

TEST MATERIAL
- Amount applied: Each dose was weighed out and 20-25 mL of normal saline was added to moisten the material. A dose level of 20000 mg/kg was applied.


Duration of exposure:
14 days
Doses:
20000 mg/kg
No. of animals per sex per dose:
3/sex/group
Control animals:
no
Details on study design:
Two females and one male received the substance applied to abraded skin, two males and one female received the substance on intact skin.

Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Mortality:
No mortalities occurred in the study
Clinical signs:
Fecal staining/soft stool, nasal discharge, ocular discharge, collar removed by animal, piloerection, motor activity increase and aggressive behaviour.
Body weight:
A slight loss of weight was noted in one abraded animal and a failure to gain weight was exhibited by two non-abraded animals. In-life signs observed within 24 hours of dosing included motor activity decrease and ataxia.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
LD50 was estimated > 20000 mg/kg bw.