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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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