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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
16 May - 21 June 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
adopted Dec 2001
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Oleic acid, compound with (Z)-octadec-9-enylamine (1:1)
EC Number:
248-813-1
EC Name:
Oleic acid, compound with (Z)-octadec-9-enylamine (1:1)
Cas Number:
28065-97-6
Molecular formula:
C34H69NO2 C36H67NO2 C36H69NO2 C36H71NO2 C36H73NO2
IUPAC Name:
oleic acid, compound with (Z)-octadec-9-enylamine (1:1)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 159 - 185 g
- Fasting period before study: yes, overnight
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK, ad libitum
- Water: 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

IN-LIFE DATES: From: 16 May 2017 To: 21 June 2017

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Remarks:
for the dose level of 300 mg/kg bw; unchanged (no vehicle): for the dose level of 2000 mg/kg bw
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Arachis oil was used because the test substance did not dissolve/suspend in distilled water.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
1 (300 mg/kg bw) and 5 (2000 mg/kg bw)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations were made 30 min, 1, 2 and 4 h after dosing and thereafter daily for 14 days. Morbidity and mortality checks were performed twice daily, early and late during normal working days, and once daily at weekends and public holidays. Individual body weights were recorded on Day 0 (day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed by cervical dislocation and subjected to gross necropsy.

Results and discussion

Preliminary study:
In the sighting test, one female rat was treated at 300 mg/kg bw by gavage. Neither mortality nor clinical signs of toxicity were observed up to the end of the observation period; no obvious effect on body weight and no pathological abnormalities at necropsy were further noted. Therefore, a further experiment was conducted, testing 2000 mg/kg bw in one additional animal.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: 2000 mg/kg bw: only the initial treated female showed hunched posture on Days 5 - 8 and pilo-erection on Days 6 - 8. 300 mg/kg bw: No clinical signs were observed.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
CLP: not classified