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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Pre-OECD, pre-GLP study, somewhat similar to OECD 401, without detailed documentation, result acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Remarks:
Pre-OECD study, performed somewhat similar to OECD TG 401, reported without detailed documentation.
GLP compliance:
no
Remarks:
pre-GLP study
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
6-tert-butyl-1,1-dimethylindan-4-yl methyl ketone
EC Number:
236-114-4
EC Name:
6-tert-butyl-1,1-dimethylindan-4-yl methyl ketone
Cas Number:
13171-00-1
Molecular formula:
C17H24O
IUPAC Name:
6-tert-butyl-1,1-dimethylindan-4-yl methyl ketone
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Not specified

Administration / exposure

Route of administration:
oral: unspecified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period: 14 days
- Frequency of observations: daily
No further experimental details provided in the report.

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Four of ten animals died, deaths were observed on day 2, 4, 6 and 7.
Clinical signs:
Enteritis and pneumonia

Applicant's summary and conclusion

Interpretation of results:
other: not classified: criteria not met
Remarks:
according to EU CLP Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
The key acute oral toxicity test (Denine, 1973) presented in this study record showed an LD50 of >5000 mg/kg bw.
Based on this key study and additional available studies presented in the Endpoint Summary, all presenting LD50's > 2000 mg/kg bw, the substance does not need to be classified for acute oral toxicity according to EU CLP Regulation (EC) No. 1272/2008 and its amendments. However, note that classification is warranted for GHS based on the additional available study from Avon (1977) presenting a LD50 of 3690 mg/kg bw, resulting in acute oral toxicity hazard Category 5 classification.
Executive summary:

Acute oral toxicity was assessed in a pre-OECD, pre-GLP study in which 10 rats were administered the substance at a dose level of 5000 mg/kg bw. Four of ten animals died, deaths were observed on day 2, 4, 6 and 7. Clinical signs included enteritis and pneumonia. The acute oral LD50 for the substance in rats was determined to be greater than 5000 mg/kg bw.