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Diss Factsheets

Administrative data

Description of key information

The acute oral LD50 of Amidoaminethoxylate (REWOSOFT TE 19L) for both male and female rats was estimated to be over 5000 mg/kg bw.

The acute dermal LD50 of Amidoaminethoxylate (REWOSOFT TE 19L) for both male and female rats was estimated to be over 5000 mg/kg bw.

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
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
other: GB/T 21603-2008 Chemicals - Test method of acute oral toxicity
Version / remarks:
Chinese National Standard
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:ST02697671
- Storage condition of test material: room temperature, avoid humidity and direct sunlight
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: TianQing biotechnology Ltd. ChangSha, China
- Weight at study initiation: 186 - 208 g bw
- Fasting period before study: overnight
- Housing: SPF Barrier environment
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C
- Humidity (%): 57 - 68 %
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 333.3 mg/ml
MAXIMUM DOSE VOLUME APPLIED: 1.5 mL/100 g bw

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male + 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: no detectable clinical signs occurred
Gross pathology:
no abnormal necropsy findings
Conclusions:
The acute oral LD50 of REWOSOFT TE 19L for both male and female rats was estimated to be over 5000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

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
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
other: GB/T 21606-2008 Chemicals - Test method of acute dermal toxicity
Version / remarks:
Chinese National Standard
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ST02697671
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: TianQing biotechnology Ltd. ChangSha, China
- Weight at study initiation: 207 - 229 g bw
- Fasting period before study: -
- Housing: SPF Barrier environment
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C
- Humidity (%): 57 - 68 %
Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: approx. 10 percent of body surface area
- Type of wrap if used: surgical gauze patch and adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done):with room temperature tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.6.mL/100 g bw
- Concentration (if solution): 833.3 mg/mL
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male + 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: no detectable clinical signs occurred
Gross pathology:
no abnormal necropsy findings
Conclusions:
The acute dermal LD50 of REWOSOFT TE 19L for male and female rats was estimated to be over 5000 mg/kg.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Justification for classification or non-classification