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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

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
Reference substance name:
Sodium cocoyl glycinate (SCG) [INCI]
IUPAC Name:
Sodium cocoyl glycinate (SCG) [INCI]

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories
- Age at study initiation: 11 weeks
- Weight at study initiation: 178 - 200 g
- Fasting period before study: none, except overnight fasting period before dosing
- Housing: in groups of three in Makrolon type-4 cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): light / dark cycle of 12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Limit dose
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality daily, body weighs on test days 1, 8 and 15
- Necropsy of survivors performed: yes
Statistics:
No

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured during the study
Clinical signs:
No clinical signs observed during the study
Body weight:
not influenced
Gross pathology:
No macroscopic findings were recorded at necropsy
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of Hostapon SG after single oral administration to rats is greater than 2000 mg/kg body weight
Executive summary:

The commercial product Hostapon SG was investigated for its acute oral toxicity according to the OECD 423. Six female rats were treated per gavage at 2000 mg/kg bw. No effect was found. The LD50 > 2000 mg/kg bw was obtained.