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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 May 2003 - 16 Jun 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP. However, there is no data on test material purity given in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(adopted 17 Dec 2001)
Deviations:
yes
Remarks:
(no data on test material purity given)
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Amides, C18, branched and linear
Molecular formula:
Not applicable as UVCB
IUPAC Name:
Amides, C18, branched and linear
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
- Name of test material (as cited in study report): PERFAD FM 3337
- Physical state: cream coloured paste
- Analytical purity: no data
- Lot/batch No.: 607459
- Storage condition of test material: at room temperature protected from light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain specification: Crl: (CD (SD) IGS BR
- Source: Charles RIver (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Fasting period before study: overnight prior to dosing and 3 h after dosing
- Housing: in groups of 3 in suspended solid-floor propylene cages furnished with woodflakes
- Diet: Certified Rat and Mouse Diet (Code 5LF2, International Product Supplies Limited, Wellingborough, Northants, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual):
The test material was freshly prepared, as required, as a solution at the appropriate concentration in DMSO. To aid preparation the test material and formulations were warmed in a warming bath at 40°C before use.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data suggesting the test material was toxic, 2000 mg/kg bw was chosen as starting dose.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
A total of six females divided into 2 groups were dosed with 2000 mg/kg bw
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1, 2 and 4 h after dosing and subsequently once daily thereafter
- Frequency of weighing: prior to dosing and 7 and 14 days after treatment
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality observed throughout the study period.
Clinical signs:
other: Red/brown staining of snout was observed for on female on Day 1 and 2 post dosing. All other females apperaed normal throughout the study period.
Gross pathology:
There were no abnormal findings noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified