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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
18 Jul - 21 Aug 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
GLP compliance unknown, minor deviations from guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
adopted 17 Dec 2001
Deviations:
yes
Remarks:
- Animals should be 8-12 weeks old, but were 7 weeks old - No information on sighting study
GLP compliance:
not specified
Remarks:
in-house safety study
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(2,2,4-trimethyl-3,4-dihydroquinolin-l (2H)-yl)ethanone
EC Number:
855-228-0
Cas Number:
4497-59-0
Molecular formula:
C14 H19 N O
IUPAC Name:
1-(2,2,4-trimethyl-3,4-dihydroquinolin-l (2H)-yl)ethanone

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Japan Inc.
- Age at study initiation: 7 weeks
- Weight at study initiation: 147 - 178 g
- Fasting period before study: Animals were fasted 20 h prior to administration and 4 h after.
- Housing: 2 - 3 animals per cage in aluminium cages
- Diet: solid mouse and rat chow (CRF-1, Oriental Yeast Co., Ltd.); ad libitum (besides fasting period)
- Water: filter-treated Osaka municipal tap water automatic water drinking device; ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 26
- Humidity (%): 40 - 70
- Air changes (per hr): ≥ 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
methylcellulose
Remarks:
0.5% methylcellulose aqueous solution
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 10 and 30 minutes and 1, 2 and 4 hours after administration and once daily thereafter, for 14 days. Individual body weights were determined immediately before administration, 7 and 14 days after administration, and in the event of being discovered dead.
- Necropsy: Performed at the end of the observation period and in the event of being discovered dead.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000
Based on:
test mat.
Remarks on result:
other: No statistics were applied to determine an exact LD50.
Mortality:
300 mg/kg bw: No deaths occurred.
2000 mg/kg bw: 3 animals were found dead 2 days after administration (cumulative
mortality 3/5).
Clinical signs:
other:
Gross pathology:
300 mg/kg bw: No effect attributable to administration of the test substance occurred.
2000 mg/kg bw: No effect attributable to administration of the test substance was noted in the surviving animals. Among the animals which died, retention of gas in the stomach was seen in 1 animal, and retention of liquid in the stomach and scattered reddened foci in the mucosa of the glandular stomach were noted in 2 animals each.

Applicant's summary and conclusion

Interpretation of results:
other: Acute Oral 4 (H302) according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study in rats a LD50 value of 300 - 2000 mg/kg bw was determined.