Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
August 18, 1978 - September 15, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4'-tert-butyl-2',6'-dimethyl-3',5'-dinitroacetophenone
EC Number:
201-328-9
EC Name:
4'-tert-butyl-2',6'-dimethyl-3',5'-dinitroacetophenone
Cas Number:
81-14-1
Molecular formula:
C14H18N2O5
IUPAC Name:
1-(4-tert-butyl-2,6-dimethyl-3,5-dinitrophenyl)ethanone
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: IFF; (CS) HRH-06-190; Off-white, crystalline powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, PA, USA
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Weight at study initiation: 150-200g
- Fasting period before study: 12 hours prior to dosing
- Housing: Individually in suspended, wire-bottomed, stainless steel cages
- Diet: Purina rat chow ad libitum
- Water: ad libitum
- Acclimation period: Minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 23.3°C
- Humidity: 45-55%
- Photoperiod: artificial light cycle of 12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 0.8 ml/100 gm body weight, equivalent to 5000 mg/kg bw
Doses:
The 5 doses levels evaluated in the initial range-finding study (2 males/2 females) were not disclosed. The single dose level evaluated in the main study was 5000 mg/kg bw.
No. of animals per sex per dose:
2 rats/sex/dose in the initial range-finding study.
5 rats/sex/dose in the main study.
Control animals:
no
Details on study design:
-Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for pharmacotoxic signs at 1, 3, and 6 hours following intubation, and daily thereafter. Bodyweights were measured prior to dosing and 14.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
An initial range-finding study evaluated 5 doses levels in 2 males and 2 females (doses were not disclosed). No deaths were reported in the range finding study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed in male or female rats during the study.
Clinical signs:
other: All animals exhibited sedation and/or piloerection at 1 hour following intubation, and tremors, some sedation, and respiratory abnormalieies (depression and short, rapid respiration) at 3 and 6 hours following intubation. test animals showed no pharmacoto
Gross pathology:
A single animal had an enlarged spleen. Otherwise, no gross pathological organ changes were observed in any animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study in Sprague-Dawley rats, the LD 50 (male/female) was > 5000 mg/kg bw.
Executive summary:

In an acute oral toxicity study (55049), Sprague-Dawley rats (5/dose/sex) were given musk ketone in corn oil by gavage at doses of 5000 mg/kg bw and observed for 14 days.

LD50 (male/female): was >5000 mg/kg bw.

No mortality was observed in male or female rats during the study. All animals exhibited sedation and/or piloerection at 1 hour following intubation, and tremors, some sedation, and respiratory abnormalities (depression and short, rapid respiration) at 3 and 6 hours following intubation. Test animals showed no toxic signs on day 1, and continued to remain normal during the remainder of the 14-day observation period. Body weights at days 0 and 14 were within a normal range for both male and female animals. A single animal had an enlarged spleen; otherwise, no gross pathological organ changes were observed in any animals.