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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 10, 2007 - May 03, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study conform with Directive 2004/73/EC, B.1 tris, OECD Guideline No. 423

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Details on test material:
Identity: AES
Batch no.: LSF7
Expiration date: February 15, 2008
Purity: 80.3%
Stability in water: Max. 30 days at room temperature
Solubility in water: Very soluble
Aggregate state / physical form
at room temperature: Solid
Storage conditions: In the refrigerator at about 4 °C
Specific instructions: Slightly hygroscopic

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Test system: Rat, HanRCC: WIST (SPF)
- Source: RCC Ltd, Laboratoty Animal Services, CH-4414 Füllinsdorf / Switzerland.
- Age at study initiation: 11 weeks
- Number of animals per group: 3 females
- Total number of animals: 6 females
- Fasting period before study: 18 to 19 hours ( access to water was permitted)
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 89/06 ad libitum.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf ad libitum

ENVIRONMENTAL CONDITIONS:
Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22°C +/- 3°C and for relative humidity between 30-70%, automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Purified water was found to be a suitable vehicle. The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.
The dosing volume was 10 mL/kg body weight (concentration: 0.2 g/mL test item diluted in purified water).
Rationale: Oral administration was considered to be an appropriate method as it is a possible route of human exposure during manufacture, handling and use of the test item.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6 female
Control animals:
no
Details on study design:
Observations:
Mortality/Viability: Daily during the acclimatization period, during the first 30 minutes and at approx. 1, 2, 3 and 5 hours after administration on
test day 1 and twice daily during days 2-15.
Body Weights: On test days 1 (prior to administration), 8 and 15.
Clinical Signs: Daily during the acclimatization period, during the first 30 minutes and at approx. 1, 2, 3 and 5 hours after administration on
test day 1 and twice daily during days 2-15. All abnormalities were recorded.
Necropsy: All animals were killed at the end of the observation priod by Carbon dioxide asphyxiation and discarded after macroscopic
examinations were performed. No organs or tissues were retained.
Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No death occurred during the study.
Clinical signs:
Three animals showed a slightly ruffled fur 2 hours post-dose which persisted up to the 5-hour reading. No clinical signs were observed in the threeother females.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No data
Other findings:
No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (female rat): greater than 2000 mg/kg body weight