Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and appropriate guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
USA EPA Guidelines OPPTS 870.1200
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
DINOL, CAS number 3296-90-0, White crystalline solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
No of animals: Five males and five females, females nulliparous and non pregnant.
Weight: 200g at start of the study, weight variation did not exceed ± 20% of the mean weight for each sex.
Age: eight to twelve weeks of age.
The diet, drinking water and bedding was routinely analysed.
Husbandary: Housed individually during 24-hour exposure period and in groups of five, by sex, for the reminder of the study.
Temp: 19-25°C, Relative humidity: 30-70%

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self adhesive bandage. After 24 hour contact period
the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material.
Duration of exposure:
24 hour exposure period
Doses:
500 mg/kg
No. of animals per sex per dose:
5 male, 5 female
Control animals:
not required
Details on study design:
The animals were observed for deaths or over signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
At the end of the study the animals were killed by cervical dislocation. All animals were subjected to gross necroscopy. This consisted of an external examination and opening of the abdominal and thoractic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues
were retained.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
There were no deaths
Clinical signs:
no signs of systemic toxicity
Body weight:
All animals showed expected gains in body weigh over the study period exept for one female which showed no gain in body weight during the first week but expected gain in body weight during the second week.
Gross pathology:
No abnormalities were noted at necroscopy

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 5000 mg/kg
bodyweight.