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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
November 1997 - September 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to international guidelines.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(Cyclopropylcarbonyl)-α,α-dimethyl-ethyl ester benzeneacetic acid
EC Number:
605-546-9
Cas Number:
169280-10-8
Molecular formula:
C16 H20 O3
IUPAC Name:
4-(Cyclopropylcarbonyl)-α,α-dimethyl-ethyl ester benzeneacetic acid
Details on test material:
Batch: Dest.3-1 of April, 1997 from PT/TTF
Appearance: yellowish solid
Date of receipt: 31 October 1997
Storage conditions: at 4ºC
Expiry date: 7 April 1999

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Breeder: Iffa Crédo, 69210 L'Arbresle, France
Number and sex: one group of 10 animals (5 males and 5 females)
Age/weight: on the day of treatment, the animals were approximately 6 weeks old and had a mean body weight of 186 +/- 8g for males and 1448 +/- 5g for the females.
Acclimatization: at least five days before the start of the study.
Temperature: 21 ± 2ºC
Relative humidity: 30 to 70%
Light/dark cycle: 12 h/12 h
Ventilation: ca. 12 cycles/hour of filtered, non-recycled air.
Housing: polycarbonate cages (48 x 27 x 20 cm), each containing four to seven animals during acclimatisation and five of the same sex during the experiment.
During the acclimatisation period and after the day of exposure in the experiment, the animals had free acces to food and water.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesam oil
Details on oral exposure:
Vehicle: The substance was grinded and mixed with sesam oil prior to dosing. Homogeneity was determined by chemical analysis and guanranteed for at least 4 hours.
Dosing: volume of 10 ml/kg
Gavage: stainless steel probe fitted to a 2 ml glass syringe
Fasting: animals were deprived of food for 18 hours prior to dosing
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
other: Historical data on control animals
Details on study design:
The substance was administered to the rats as a single dose followed by 14 days of observation.
Statistics:
No data

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 observed.
Clinical signs:
other: Hypoactivity and piloerection in 2/5 males and 3/5 females on day 1 only. No others clinical signs were noted.
Gross pathology:
No abnormalities.
Other findings:
No other findings.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the oral LD50 is greater than 2000 mg/kg in rats.