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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 December 1997 - 26 December 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was performed in a GLP laboratory but was not conducted in accordance with an OECD or EU test guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
443-400-4
EC Name:
-
Cas Number:
181696-73-1
Molecular formula:
C16H15NO2
IUPAC Name:
4,5-Dihydro-5-methyl-3,4-diphenyl-5-isoxazolol
Test material form:
other: White solid
Details on test material:
- Name of test material (as cited in study report): SC-66285
- Physical state: White solid

Test animals

Species:
rat
Strain:
other: Crl:CD®(SD)BR.
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Inc. Portage, Michigan on 3 and 17 November 1997.
- Age at study initiation: Young adult
- Weight at study initiation: 200 - 300 g
- Fasting period before study: 17 to 20 hours
- Housing: suspended, stainless steel cages
- Diet (e.g. ad libitum): Rodent Diet #8604 (Harlan Teklad)
- Water (e.g. ad libitum): yes
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26°C
- Humidity (%): 50% ± 20%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
variable ( 5,000 mg/kg of body weight)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.25 g/mL
- Amount of vehicle (if gavage): 20 mL/kg
Doses:
5,000 mg/kg of body weight.
No. of animals per sex per dose:
5 males and 5 females for the initial dose level
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2.5 and 4 hours after initial administration and daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights and necropsy were measured and/or performed.

Results and discussion

Preliminary study:
No mortality was observed during the study. The estimated oral LD5o values for male and female rats were determined to be greater than 5,000 mg/kg of body weight.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
None.
Clinical signs:
other: None.
Gross pathology:
None.

Applicant's summary and conclusion

Interpretation of results:
other: The estimated oral LD50 values for male and female rats were determined to be greater than 5,000 mg/kg.
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
In conclusion, a single oral dose of SC-66285 by oral gavage did not cause clinical signs or mortality. The estimated oral LD50 values for male and female rats were determined to be greater than 5,000 mg/kg.
Executive summary:

The acute oral lethality potential of SC-66285 was evaluated in five male and five female rats. A single oral dose of SC-66285 by oral gavage did not cause clinical signs or mortality. The estimated oral LD50 values for male and female rats were determined to be greater than 5,000 mg/kg.