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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:
13 March 1989 to 11 september 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
Molecular formula:
C14H24O1
IUPAC Name:
Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
Constituent 2
Chemical structure
Reference substance name:
Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
Molecular formula:
C15H24O
IUPAC Name:
Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
Constituent 3
Chemical structure
Reference substance name:
Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
Molecular formula:
C15H24O
IUPAC Name:
Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
Constituent 4
Chemical structure
Reference substance name:
Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
Molecular formula:
C15H24O
IUPAC Name:
Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
Test material form:
liquid
Specific details on test material used for the study:
Substance name (as stated in the report): NECTARYL - LRG 1371
Description: colourless slightly viscous liquid
Batch: AS1241001

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Strain justifictaion: historically the rat has been used to determine acute toxicity of test substances and is chosen by the various regulatory authorities.
- Source: Iffa-Credo (69210 L'Arbresle - France)
- Age: young adults between 5 and 7 weeks old
- Weight at the start of treatment: from 145 g to 183 g (the individual weights for each sex varied by no more than 20 % of the mean weights of the animals)
- housing: Cages housed by sex and in groups of 5 (or 2 for the preliminary study), in type FI polycarbonate cages (interior dimensions 305 x 180 x 184 mm) for the preliminary study and in type MI (interior dimensions 365 x 225 x 180 mm) for the main study
- Air changes: at least 10 per hour
- Temperature: 21 to 27°C
- Humidity: 44 to 79 % R.H
- Lighting artificial: 12 hours out of 24 (photoperiod = 7h30 - 19h30)
- Hygiene: bedding changed once a week; cages changed for each study

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
test substance as supplied
Details on oral exposure:
- The test substance was administered once only after about 17 hours of a water only regime, the animals receiving food 4 hours after the intubation.
- Volume administered: 2.07 ml/kg of test substance as supplied
Doses:
A single dose level of 2008 mg/kg
No. of animals per sex per dose:
1 single dose to 5 males and to 5 females
Control animals:
no
Details on study design:
Since the absence of mortality was confirmed after the 14 day period, no other dose level was administered and the study was completed.

Results and discussion

Preliminary study:
No deaths were seen at the dose level of 2008 mg/kg during the preliminary study.
Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 008 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 008 mg/kg bw
Based on:
test mat.
Remarks on result:
other:
Remarks:
No mortality observed at highest dose tested
Mortality:
There were no deaths in any of the treated animals during the observation period.
Clinical signs:
There were no changes in behaviour or clinical signs in any of the treated animals during the observation period.
Body weight:
Body weight changes in the treated animals were not influenced by treatment
Other findings:
There were no macroscopic findings that could be associated with treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
There were no effect of treatment in any of the parameters examined.
From the results obtained under the experimental conditions employed, the LD0 by oral route, in the rat, of the test substance administered once only, as supplied, is greater than or equal to 2008 mg/kg.
Executive summary:

NECTARYL was tested to evaluate the acute toxicity following a single oral administration (limit test) in rats according to the Guideline No. 401.

The test substance was administered, once only, as supplied and at the dose level of 2008 mg/kg, by the oral route (gastric gavage),in the Sprague-Dawley rat (5 males + 5 females).

Mortality and abnormal clinical signs were noted 15 minutes after intubation, and 1, 2 and 4 hours,and then daily for the 14day study period.

All animals were weighed the day before treatment (Day-1), immediately before administration of the test substance (Day1), on Days 8 and 15.

A necropsy was performed for all the animals after the 14day study period and the final observation (Day15).

There were no effect of treatment in any of the parameters examined.

From the results obtained under the experimental conditions employed, the LD0 by oral route, in the rat, of the test substance administered once only, as supplied, is greater than or equal to 2008 mg/kg.