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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:
26th May 1998 to 9th June 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A GLP compliant study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde
EC Number:
224-815-8
EC Name:
(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde
Cas Number:
4501-58-0
Molecular formula:
C10H16O
IUPAC Name:
2-[(1R)-2,2,3-trimethylcyclopent-3-en-1-yl]acetaldehyde
Details on test material:
- Name of test material (as cited in study report): ALDEHYDE CAMPHOLENIQUE DROIT
- Physical state: colourless liquid
- Storage condition of test material: at room temperature, away from light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source :IFFA-CREDO (69210 - L'Arbresle, France)
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: 172-204 g (males); 172-191 g (females)
- Fasting period before study: overnight
- Diet (e.g. ad libitum): complete pelleted rat maintenance diet UAR A04-10 (91360- Epinay Sur Orge, France)
- Housing: polypropylene cages (310 x 465 x 190)
- Acclimation period: at least 5 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
2000 mg/kg
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: a clinical observation was carried out at least once a day in order to evaluate the general appearance, behaviour and vegetative functions of the animals. An individual clinical observation was performed one hour after treatment. The continuous observations during the following five hours were each renewed the following day. Bodyweights were taken just prior to administration of the test substance and again on days 4, 8 and 15.
- Necropsy of survivors performed: at termination of the study, the rats were sacrificed and all abnormalities recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
Just after the treatment, and during the first six hours following administration of the test substance, a slight piloerection was noticed in all animals with a decrease in motor activity and in muscle tone (staggering gait) appearing 1 hour after treatment in female number 9293. The following day, no modification in the aspect, behaviour or vegetative functions were observed in any animals.
Body weight:
The individual bodyweight of all animals was normal and regular. The mean weight gain 14 days after treatment appeared in line with expectations.
Gross pathology:
Gross necroscopy of animals 14 days after treatment did not show any visible organic or tissular lesions which may imply a possible systemic toxicity of the test substance.

Any other information on results incl. tables

Table 1: Individual animal bodyweights

 Animal number  D1  D4  D8  D15  D15 -D1
 Male               

 9285

 185.0  201.6  264.0  331.8  146.8
 9286  172.2  193.3  251.8  311.0  138.8
 9287  180.6  202.0  264.8  324.7  144.1
 9288  203.8  207.9  262.9  332.3  128.5
 9289  178.4  192.3  255.4  307.7  129.3
 Mean  184.0  199.4  259.8  321.5  137.5
 SD  12.0  6.5  5.8  11.6  8.4
 Female               
 9290  182.2  184.5  215.7  233.2  51.0
 9291  187.6  199.5  238.3  264.8  77.2
 9292  190.8  203.2  227.4  259.3  68.5
 9293  180.8  189.4  235.9  258.6  77.8
 9294  172.0  189.9  221.6  238.4  66.4
 Mean  182.7  193.3  227.8  250.9  68.2
 SD  7.2  7.8  9.5  14.1  10.9

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the acute oral toxicity of the test substance was determined to be LD50 >2000 mg/kg bw.
Executive summary:

In a GLP compliant acute oral toxicity study conducted in line with standardised guideline OECD 401, the acute oral toxicity of the test substance was determined. Under the conditions of the test, the LD50 of the test substance in rats was determined to be >2000 mg/kg bw and so the substance is considered to be unclassified for acute oral toxicity.