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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:
February 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: NOTE: PH WAS NEUTRALISED. Performed according to OECD guideline and under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Description: amber-coloured liquid
Container: glass screw-top bottle
Sponsor's identification : AMPHOLAK X00-30P
Date of arrival : 15 April 1987
Storage conditions : room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River.(UK) Limited, Margate, Kent
- Age at study initiation: Young
- Weight at study initiation: Day 1 between 81- 97g
- Fasting period before study: Animals were fasted overnight prior to dosing
- Housing: single sex groups of five in grid bottomed polypropylene cages.
- Diet (e.g. ad libitum): A commercially available pelleted rodent diet (SQC R and M No.1 expanded produced by Special Diet Services, Witham, Essex) ad libitum.
- Water (e.g. ad libitum): mains drinking water via polypropylene bottles were provided ad libitum.
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 49-61
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: 6 February 1987 - 15 days later

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

DOSAGE PREPARATION (if unusual): The test material was neutralised to a pH of 7.0 using 1.0M citric acid and was then diluted with distilled water to give a dose volume of 20ml/kg at a dose level of 5000mg/kg.
Doses:
5g/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were examined frequently after dosing and then daily for fourteen consecutive days. Any signs of toxicity or other effects were noted along with the time of onset and duration. Animals were weighed at weekly intervals.
- Necropsy of survivors performed: yes, at the end of the fourteen day post dose observation period all animals were weighed and then sacrificed by carbon dioxide asphyxiation. Animals were then subjected to gross examination including the opening of the thoracic and visceral cavities.
Statistics:
Not applicable

Results and discussion

Preliminary study:
Not performed
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: None of the animals died.
Mortality:
No mortalities observed.
Clinical signs:
No effects of treatment observed.
Body weight:
No effects of treatment observed.
Gross pathology:
No abnormalities noted on necropsy.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The results of this study indicate that the test material has no toxic effect when administered as a single oral dose to the rat at a dose level of 5000mg/kg bodyweight. The composition of the test material is estimated to be 40% active ingredient (incl NaCl) and 60 % water. Therefore, based on the active ingredient, the tested dose level is considered to be 2000 mg/kg bw based on Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1). The LD50 > 2000 mg/kg bw. NOTE: PH WAS NEUTRALISED.
Executive summary:

An acute oral limit test was performed under GLP and according to OECD 401. Following overnight fasting a group of five male and five female rats were administered the test material, by peroral injection, at a dose level of 5000 mg/kg bodyweight. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment. No effects of treatment were observed throughout the duration of the study and no. abnormalities were detected at necropsy. The results of this study indicate that the technical product consisting of 40% Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1) in aqueous solution has no toxic effect when administered as a single oral dose to the rat at a dose level of 5000mg/kg bodyweight.

Based on the composition of the technical product, the dose level tested is considered to be 2000 mg active ingredient/kg bw based on Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1). Under the conditions of this study the LD50 > 2000 mg a.i./kg bw. NOTE: PH WAS NEUTRALISED.