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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:
From 1991-07-11 to 1991-07-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study performed according to OECD test guideline No. 401 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
During the acclimation period the temperature rose above the range 19-25°C on several occasions, a maximum temperature of 33°C being recorded on one occasion.
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
UK GLP (inspection date: 1990-06-19 / signature date: 1990-10-05)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(5E)-3-Methyl-5-cyclopentadecen-1-one
Cas Number:
101151-17-1
Molecular formula:
C16 H28 O
IUPAC Name:
(5E)-3-Methyl-5-cyclopentadecen-1-one
Constituent 2
Chemical structure
Reference substance name:
(5Z)-3-Methyl-5-cyclopentadecen-1-one
Cas Number:
21944-94-5
Molecular formula:
C16 H28 O
IUPAC Name:
(5Z)-3-Methyl-5-cyclopentadecen-1-one
Constituent 3
Chemical structure
Reference substance name:
(4E)-3-Methyl-4-cyclopentadecen-1-one
Cas Number:
62221-84-5
Molecular formula:
C16 H28 O
IUPAC Name:
(4E)-3-Methyl-4-cyclopentadecen-1-one
Test material form:
liquid
Details on test material:
- Physical state: colourless liquid
- Reception date: 1991-06-27
- Storage condition of test material: in the dark at about 4°C

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)BR strain (VAF plus)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Limited, Margate Kent
- Age at study initiation: 5-7 weeks
- Weight at study initiation: M: 110 to 129 g; F: 119 to 127
- Fasting period before study: overnight before dosing
- Housing: in groups of 5, by sex, in grid bottomed cages suspended over cardboard lined excreta trays
- Diet: pelleted diet ad libitum (SQC rat and mouse maintenance No. 1 expanded, produced by Special Diets Services, Witham, Essex).
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C/ During the acclimatisation period the temperature rose above this range on several occasions, a maximum temperature of 33°C being recorded on one occasion.
- Humidity (%): 42-62 %
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: not justified
- Lot/batch no. (if required): no data
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Assess to food was permitted immediately after dosing
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: approximately 30 minutes, 1, 2 and 4 hours afters dosing and thereafter for 14 consecutive days.
Weighing: on the day of dosing, on days 8 and 15.
- Necropsy of survivors performed: yes, including opening of the thoracic and visceral cavities, opening and examination of the stomach and representative sections of the gastro-intestinal tract and examination of the major organs. Abnormal tissues and organs were preserved in buffered formol saline.
Statistics:
not done

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred throughout the study
Clinical signs:
No clinical signs were observed throughout the study
Body weight:
There was no adverse effect on bodyweight gain
Gross pathology:
The necropsy findings were consistent with the background macroscopic pathology of this strain of rats:
- Urinary bladder: contained white waxy plug in 1M
- Left eye: appeared small, palpebral fissure reduced in size in 1M
- Uterus: minimally distended with fluid in 1F
Other findings:
None

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Oral LD50Combined > 2000 mg/kg bw
Executive summary:

In a limit acute oral toxicity study performed according to the OECD test guideline No. 401 and in compliance with GLP, groups of fasted, 5-7 weeks old, Crl:CD(SD) rats (5/sex) were administered a single oral dose of 2000 mg test material/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.

 

No mortality and no clinical signs were observed throughout the study. There was no adverse effect on bodyweight gain. No abnormality was revealed at autopsy.

 

Oral LD50Combined > 2000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.