Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4th November 2004 to 18th November 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in compliance with: • OECD guideline No. 402, 24th February 1987, • EC Directive No. 92/69/EEC, B.3, 31st July 1992.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
The relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the Study plan.
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
yes
Remarks:
The relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the Study plan.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Beige powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Number and sex: one group of ten animals (five males and five females). Females were nulliparous and non-pregnant.
Age/weight: on the day of treatment, the animals were approximately 8 weeks old and had a mean body weight ± standard deviation of 333 ± 15 g
for the males and 214 ± 4 g for the females.
Acclimation: at least 5 days before the beginning of the study.
Identification: individually by earnotches.

The conditions in the animal room were set as follows:
• temperature: 22 ± 2°C
• relative humidity: 30 to 70%
• light/dark cycle: 12 h/12 h
• ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these
daily checks, the housing conditions and corresponding instrumentation and equipment are verified and calibrated at regular
intervals.
During the acclimation period, one to seven animals of the same sex were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm).
During the treatment period, the animals were housed individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm).
Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
Sawdust is analyzed by the supplier for composition and contaminant levels.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
No clinical signs, no deaths and no cutaneous reactions were observed during the study.
A reduced body weight gain was seen in 1/5 females between day 8 and day 15.
The overall body weight gain of the other animals was similar to that of CIT historical control animals.
No apparent abnormalities were observed at necropsy in any animal.
Duration of exposure:
The test site was covered by a semi-occlusive dressing for 24 hours.
Doses:
The application was performed with the test item in its original form at the dose-level of 2000 mg/kg.
No. of animals per sex per dose:
The test item was applied to the skin of one group of ten Sprague-Dawley rats (five males and
five females).
Control animals:
no
Details on study design:
As the test item was anticipated to be non-toxic at 2000 mg/kg, a limit test was performed by application of 2000 mg/kg of the test item to one
group of ten animals (five males and five females).

Results and discussion

Preliminary study:
Under the experimental conditions, the dermal LD50 of the test item is higher than 2000 mg/kg in rats.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs and no cutaneous reactions were observed during the study.
Body weight:
A reduced body weight gain was seen in 1/5 females between day 8 and day 15.
The overall body weight gain of the other animals was similar to that of CIT historical control animals.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the dermal LD50 of the test item is higher than 2000 mg/kg in rats.
Executive summary:

Under the experimental conditions, the dermal LD50 of the test item is higher than 2000 mg/kg in rats.