Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Experimental result for an structural analogue. Peer-reviewed data, it is assumed that variety of data sources have been consulted, that the test methodology and identity of the test substance has been evaluated, and that a reliable and representative value for the endpoint has been selected.

Data source

Reference
Reference Type:
publication
Title:
A safety assessment of branched chain saturated alcohols when used as fragrance ingredients
Author:
D. Belsito, D. Bickers, M. Bruze, P. Calow, H. Greim, J.M. Hanifin, A.E. Rogers, J.H. Saurat, I.G. Sipes, H. Tagami, The RIFM Expert Panel
Year:
2010
Bibliographic source:
Food and chemical Toxicology 48 (2010) S1-S129

Materials and methods

Test guideline
Qualifier:
no guideline available
Guideline:
other: not detailed
GLP compliance:
not specified
Test type:
other: no data

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,6-Dimethyl-4-heptanol
- Molecular formula (if other than submission substance): C9H20O
- Molecular weight (if other than submission substance): 144.25 g/mol
- Structural formula attached as image file (if other than submission substance): see Fig. 1
- Substance type: secondary alcohol
- Log Kow (calculated; EPA, 2010): 3.08.
- Boiling point (calculated; EPA, 2010): 177.59 C.
- Henry’s law (calculated; EPA, 2010): 0.0000412 atm m3/mol
- Vapor pressure: (calculated; EPA, 2010): 0.334 mm Hg; 44.5 Pa (25 C).
- Water solubility (calculated; EPA, 2010): 613.8 mg/l @ 25 C.
- UV spectra available, does not absorb UV light.

Test animals

Species:
rat
Sex:
male

Administration / exposure

Route of administration:
oral: unspecified
Details on oral exposure:
single dose
Doses:
4 doses: 1000, 2000, 4000 and 8000 mg / Kg of bodyweight
No. of animals per sex per dose:
5 males per dose
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3 560 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 430 - <= 8 860

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This substance is regarded as not classified for acute oral toxicity according to REGULATION (EC) No 1272/2008 (CLP) as LD50 > 2.000 mg/Kg of bodyweight.
Executive summary:
Five rats per dose were given a single dose of 2,6-dimethyl-4 -heptanol at 1000, 2000, 4000, and 8000 mg/kg bodyweight. Observations for mortality and or systemic effects were made for 14 days. The acute oral LD50 in rats was calculated to be 3560 mg/kg of bodyweight, with a 95% confidence interval of 1430 – 8860 mg/kg of bodyweight).

Reference cited: Smyth, H.F., Carpenter, C.P., Weil, C.S., 1949. Range-finding toxicity data, list III. The Journal of Industrial Hygiene and Toxicolology 31 (1), 60–62.