Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 June 1991 to 20 June 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The methodology used in this study was equivalent to the current guideline requirements at the time the study was conducted. Although there are some minor deficiencies in reporting compared to modern requirements, the study is considered suitable as a key study for acute oral toxicity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not applicable
Qualifier:
equivalent or similar to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
not applicable
Principles of method if other than guideline:
The procedures used in this study met the requirements of the test for acute dermal toxicity described in document L251, an EEC Commission Directive of 25th April 1984.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Test Item Storage: +4 °C in the dark
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 ºC / Dark
- Stability under test conditions: Assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: N/A
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: N/A

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Recognised supplier
-Age/weight at study initiation: young adult / 200 - 300 grams
-Fasting period before study: over night fasting
-Housing: groups of five in grid bottom cages
-Diet: Pelleted rodent diet
-Water: main drinking water via polypropylene bottles
-Acclimation period: 5 days

ENVIRONMENTAL CONDITION
-Temperature: 19 -22°C
-Humidity: 39 - 62%
Photoperiod (hrs dark/hrs light: 12 hrs dark/12 hrs light)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Test site
- Area of exposure: clipped back with an Oster Model A5 clipper with size 40 blade.
- Type of occlusion if used: surgical gauze four pile thick overlaid with a strip of aluminium foil held in place with elastoplast of 5.0 cm wide.
Duration of exposure:
24 hours
Doses:
2000 mg/kg/bw
No. of animals per sex per dose:
5 per sex per dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 and subsequent daily for 14 consecutive days.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, including the nature, severity, approximate time of onset and duration of each sign. Individual body weight of rats on Days 1 (day of dosing), 8 and 15.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths following a single dermal dose of the test item at 2000 mg/kg bodyweight.
Clinical signs:
There were no signs of systemic reaction. Incidence of enlarged submandibular lymp node was slighly higher but was consistent with normal background pathology.
Body weight:
All animals acheived anticipated body weight gains throughout the study.
Gross pathology:
No gross pathological findings were observed, autopsy revealed no macroscopic abnirmalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results of an acute dermal toxicity study on the test item didt not produce any signs of toxicity and the acute lethal dermal dose LD50 to rats was found to be > 2000 mg/kg bodyweight.
Executive summary:

An acute dermal toxicity study was performed using a method similar to OECD Guideline for Testing of Chemicals 402 "Acute Dermal Toxicity", and EEC Methods for the determination of toxcity, Directives 84/449/EEC (OJ No. L251, 19.9.84), Part B, Method B3. Acute Toxicity (Dermal). The application of of the test item at a single dose of 2000 mg/kg bw to the dorsal skin of 5 rats/sex under occlusive dressing for 24hours did not produce any signs of toxicity and it is concluded that the acute dermal dose LD50 to rats was found to be in excess of 2000 mg/kg bodyweight.