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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental phase: 09 October to 02 November 2017. Report issue: 22 March 2018.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, C14-C18 and C18 unsaturated, amides with 2,2’-iminodiethanol
EC Number:
948-052-1
Molecular formula:
not applicable as UVCB
IUPAC Name:
Fatty acids, C14-C18 and C18 unsaturated, amides with 2,2’-iminodiethanol
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Female Wistar (RccHan™:WIST) strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 167 to 201g
- Fasting period before study: Overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: The animals were housed in groups of up to four in solid-floor polypropylene cages furnished with woodflakes
- Diet: provided ad libitum (except for immediately prior to and after dosing)
- Water: provided ad libitum (except for immediately prior to and after dosing)
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
- Environmental enrichment: The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
For the purpose of the 2000 mg/kg dose level, the test item was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level. For the purpose of the 300 mg/kg dose level, the test item was freshly prepared as required as a solution in dimethyl sulfoxide. Dimethyl sulfoxide was used because it produced the most suitable formulation at the required concentration.
No. of animals per sex per dose:
5 females at 2000 mg/kg bw
1 female at 300 mg//kg bw
Control animals:
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:
There were no deaths on the study.
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
Body weight:
All animals showed expected gains in body weight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight.
Executive summary:

Introduction


The study was performed to assess the acute oral toxicity of the test item in the rat. The method used was designed to meet the requirements of the following guidelines:

  

1)  OECD Guideline for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Procedure” (2001)

2) Method B1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008

 

Methods

Wister strain rats were used for the study. Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of the undiluted test item at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

 

Results

There were no deaths on the study and there were no signs of systemic toxicity. All animals showed expected gains in body weight and no abnormalities were noted at necropsy.

 

Conclusion

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight.

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