Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-08-26 to 2004-10-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant; Guideline Study (OECD 402)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
July 31, 1992
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 24,1987
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Description: red solid
- Stability of test item: Stable under storage conditions;
- Stability of test item dilution: Stable in purified water for at least two days at room temperature;
- Storage conditions: At room temperature (range of 20 ± 5 °C), light protected;
- Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel;

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services; CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: Males: 8 weeks; Females: 12 weeks
- Weight at study initiation: Males 246.3 - 255.7 g; Females 192.6 - 215 g;
- Fasting period before study: No
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz) during treatment and observation.
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 34/04 (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) ad libitum.
- Water: Community tap water from Fullinsdorf ad libitum.
- Acclimation period: Not stated in detail.

ENVIRONMENTAL CONDITIONS
- Temperature: :22 ± 3 °C
- Humidity: relative humidity between 30-70 %
- Air changes: 10-15 air changes per hour,
- Photoperiod: automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: backs of the animals
- % coverage: 10 % of the body surface;
- Type of wrap if used: semi-occlusive dressing wrapped around the abdomen and fixed with elastic adhesive bandage;

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with luke-warm water;
- Time after start of exposure: 24 hours after exposure;

TEST MATERIAL
- Amount(s) applied: 500 mg/mL;
- Constant volume or concentration used: yes - 4mL/kg bw;
- For solids, paste formed: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days;
- Frequency of observations and weighing: at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15; weighing: On test days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred.
Mortality:
No deaths occurred during the study.
Clinical signs:
No systemic signs of toxicity were observed during the course of the study.
Slight red discoloration of the treated skin area caused by the test item was observed in all animals from test day 2 to 5 and persisted up to test day 6 in two animals and up to test day 7 in two further animals.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
NA

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU