Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-04-15 to1992-04-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
Directive 84/449/EWG, 19.09.1984
Deviations:
no
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Bor: WISW (SPF Cpb)
- Source: Winkelmann, Borchen
- Age at study initiation: ca. 10 weeks (males), ca. 16 weeks (females)
- Weight at study initiation: ca. 244 g (males), 221 g (females)
- Housing: conventional Makrolon cages type II, dust-free granulate (wood).
- Diet: "fixed-formula" standard diet (altromin 1324 pellets, source: Altromin GmbH und Co KG, Lage) ad libitum
- Water: drinking water ad libitum in 300 mL flasks made of poly carbonate
- Acclimation period: 5 days
- Other: Female animals were nullipara and non-pregenant. Health of the animals were checked before study initiation. Only healthy animals without any symptoms were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 50 +/- 10 %
- Air changes: ca. 10 changes per hour
- Photoperiod: 12 h illumination (6:00 am to 6:00 pm)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flank
- % coverage: ca. 10 % of body surface
- Preparation of test site: The test site was clipped ca. 24 hours before application. The skin was not hurt.
- Patches (Fermoflex tape, Baiersdorf AG) and aluminium foil was used for coverage of the test site.

REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Concentration: 100%
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 female animals and 5 male animals
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
On day 1 of the application and during the 14-day observation period the animals were inspected twice a day (on weekend and holyday once a day) regarding clinical signs and , if necessary, dead animals were removed. Immediately before the application (day 1), after 1 week and at the end of the 14-day observation period the animals were weighted. The calculation of the individual application volume was calculated on the basis of the body weight recorded before study initiation.
- Necropsy of survivors performed: yes, using diethylether

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
During the 14-day observation period no mortality was observed.
Clinical signs:
Systemic symptoms of poisoning and local changes on the skin were not observed.
Body weight:
The growth of male rats were not influenced. Female animals showed a temporarily decrease or stagnation of their body weight.
Gross pathology:
All animals that were sacrified at the end of the study did not show any conspicious symptoms.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A LD50 value of > 2000 mg/kg bw was determined for the test substance.
Executive summary:

The test substance was examined for its acute dermal toxicity similar to EU method B.3. Ten Wistar rats were equally divided to sex. A dose of 2000 mg/kg bw was applied. The hair was clipped from the back of each animal, the test substance was applied for 24 hours and the application site was covered with patches and aluminium foil. After an observation time of 14 days no mortality was observed. The growth of male rats were not influenced. Female animals showed a temporarily decrease or stagnation of their body weight. Systemic symptoms of poisoning and local changes on the skin were not observed. All animals that were sacrified at the end of the study did not show any conspicious symptoms. Thus, the deduced LD50 values is > 2000 mg/kg bw.