Fatty acid chlorides, C8-14 (even numbered), reaction products with glycine

Acute Toxicity: oral

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

Test material information

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:

other: No clinical signs observed during the study

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 (25% sodium N-cocoyl glycinate) after single oral administration to rats is greater than 2000 mg/kg body weight

Executive summary:

The commercial product Hostapon SG (25% of sodium N-cocoyl glycinate) 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.