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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
between 20 May 2009 and I0 June 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in accordance with recognised guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
yes
Remarks:
Not considered to affect study validity
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
yes
Remarks:
Not considered to affect study validity
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of fatty acids, C18-unsatd., dimers, partly hydrogenated with N,N-dimethyl-1,3-propanediamine
EC Number:
937-688-5
Cas Number:
1391530-05-4
Molecular formula:
C46H82N4O2 to C46H94N4O2
IUPAC Name:
Reaction products of fatty acids, C18-unsatd., dimers, partly hydrogenated with N,N-dimethyl-1,3-propanediamine
Details on test material:
- Substance type: UVCB
- Physical state: amber coloured viscous liquid
- Analytical purity: > 97.5%
- Lot/batch No.: CM71117612
- Expiration date of the lot/batch: 14 April 201 0
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: 180-201 g. The bodyweight variation did not exceed 20% of the initial mean bodyweight of any previously dosed animal(s).
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: Suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25°C
- Humidity (%): 30 – 70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hours continuous light/dark.



Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): calculated to individual animal fasted bodyweight at time of dosing
- Justification for choice of vehicle: 10 ml/kg
- Lot/batch no. (if required): NDA
- Purity: NDA


MAXIMUM DOSE VOLUME APPLIED: 2 ml

DOSAGE PREPARATION (if unusual): NDA



Doses:
2000 mg/kg
No. of animals per sex per dose:
5 females / dose level
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs observed daily, body weights measured on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight no further details available
Statistics:
An estimate of the acute oral median lethal dose (LD50) of the substance was made using the mortality data obtained.

Results and discussion

Preliminary study:
Asingle female rat was dosed at a level of 2000 mg/kg bw.

There was no mortality.

As such, an additional group of 4 animals were dosed accordingly.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: The dose group for the main study includes the animal dosed in the sighting study
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted.
Body weight:
Animals showed expected gains in bodyweight, except for one animal which showed no gain in bodyweight during the first week but expected gain in bodyweight during the second week.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
- Organ weights: No Data Available
- Histopathology: No Data Available
- Potential target organs: No Data Available
- Other observations:No Data Available

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonized Classification System -Unclassified).
Executive summary:

INTRODUCTION: The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:

OECD Guidelines for Testing of Chemicals No 420 "Acute Oral Toxicity -Fixed Dose Method" (adopted 17 December 2001)

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

METHODS:Following a sighing test at a dose level of 2000 mg/kg, an additional 4 fasted female animals were given a single oral dose of test material, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

RESULTS:

Mortality:There were no deaths.

Clinical Observations:No signs of systemic toxicity were noted.

Body weight:Animals showed expected gains in bodyweight, except for one animal which showed no gain in bodyweight during the first week but expected gain in bodyweight during the second week.

Necropsy:No abnormalities were noted at necropsy.

CONCLUSION

The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonized Classification System -Unclassified).