Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50 > 2000 mg/kg bw, OECD Guideline 423, GLP compliant
Acute dermal toxicity: LD50 > 2000 mg/kg bw, OECD Guideline 402, GLP compliant

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 7 - 10 weeks
- Weight at study initiation: mean males 197 g, mean females 175 g
- Fasting period before study: 16 - 4
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The content of 50% active ingredient in the test substance was taken into account for dosis calculation.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Sex:
female
Dose descriptor:
other: LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: The treatment was tolerated without mortalites, clinical signs, effects on body weights and gross pathological findings.
Mortality:
no deaths
Clinical signs:
none
Body weight:
no effects on weight gain
Gross pathology:
no findings
Other findings:
none

Dose (mg/kg bw) Toxicological results  Onset and duration of signs  Onset of mortality
(1st) 2000 0 / 3/ 3 --- --- 
(2nd) 2000 0 / 3/ 3 --- --- 

Toxicological results:

number of dead animals / number of animals with signs of toxicity after treatment / number of animals treated

Executive summary:

In an acute oral toxicity study performed according to OECD TG 423 a single oral dose of 2000 mg/kg bw was tolerated withouth mortalities, clinical signs, effects on weight gain and gross pathological findings. Thus, the LD50 was determined for the substance with > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The study is GLP compliant and has Klimisch score 1.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1987)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: RCCHan:WIST
- Source: Harlan GmbH, 5960 AD Horst, Netherlands
- Age at study initiation: approximately 9-13 weeks
- Diet and water: ad libitum
- Acclimation period: at least 5 days
Type of coverage:
other: semiocclusive, but predominantly covered with air-tight plaster
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TREATMENT
The liquid test substance was applied pure. Dosing with 2000 mg/kg bw was based on the active ingredient content of 45.5% in water, the body weight of the animals and the surface area on which the test substance was applied.
Treatment area: 30 cm²
TEST SITE
One day before the start of the treatment the back and flanks of the rats were shorn (approximately 10% of the body surface area). For each dose and animal the required amount of the pure liquid test substance was calculated on the base of the body weight at time of dosing. This amount was weighed and applied as uniformly and thinly as possible to the test area, covered with a gauze-layer (6.0 cm x 5.0 cm = 30.0 cm²) of a "Cutiplast steril" coated with air-tight "Leukoflex". The gauze strip was placed on the rat's back and secured with a "Lomir biomedical Inc rat jacket", which was connected with a safety pin to the stretch tape to ensure that the animals could not ingest the test substance.

REMOVAL OF TEST SUBSTANCE
After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry.
Duration of exposure:
24 hours
Doses:
Limit dose of 2000 mg/kg bw ; according to 18.8 to 19.6 mg active ingredient/cm² for male rats and 16.3 to 17.1 mg active ingredient/cm² for female rats.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: at least 14 days
- Frequency of observations: once daily
- Frequency of weight determination: once weekly
- Necropsy of survivors performed: yes
Statistics:
none; limit dose test
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: no mortalities, clinical signs, toxicological effects on weight development and gross pathological findings
Mortality:
No mortalities occured.
Clinical signs:
none
Body weight:
There were no toxicologically significant effects on body weight or body weight development in males and females.
Gross pathology:
The necropsies performed at the end of the study revealed no particular findings.
Interpretation of results:
not classified
Remarks:
Migrated information
Executive summary:

In an acute dermal toxicity study on rats performed according to OECD TG 402 2000 mg/kg bw of the substance were applied to the skin of 5 male and 5 female rats for 24 hours. The test substance was tolerated by the animals without mortalities, clinical signs, toxicological effects on weight development and gross pathological findings. The resulting dermal LD50 was determined with > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The study is GLP compliant and has Klimisch score 1.

Additional information

Based on the available information the acute toxicity of AAS is low for the oral and dermal route of administration. No data are available for acute inhalation toxicity. There is no reason to believe that the low acute toxicity observed in experimental animals would not be relevant for human health.


Justification for selection of acute toxicity – oral endpoint
only one study avialable

Justification for selection of acute toxicity – dermal endpoint
only one study avialable

Justification for classification or non-classification

Based on the available data and in accordance with Regulation (EC) 1272/2008 the substance is not classified for acute toxicity.