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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
Study conducted outside the EU over 10 years before the EU cosmetic testing ban came into effect.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations 16, Part 1500.3 (USA)
Deviations:
no
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
Isodecyl 3,5,5-trimethylhexanoate
EC Number:
261-674-1
EC Name:
Isodecyl 3,5,5-trimethylhexanoate
Cas Number:
59231-35-5
Molecular formula:
C19H38O2
IUPAC Name:
8-methylnonyl 3,5,5-trimethylhexanoate
Test material form:
liquid
Specific details on test material used for the study:
Isodecyl Isononanoate
colourless liquid

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Observed for 2 weeks post-dose
Doses:
Single gavage at 5 mL/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
5 mL/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
4 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: conversion based upon density of 0.86 g/cm^3
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: conversion based upon density of 0.86 g/cm^3
Mortality:
No mortality was observed during the study period.
Clinical signs:
other: Not reported.
Gross pathology:
Not reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not toxic orally at 5 mL/kg (convered to 4300 mg/kg bw based upon a density of 0.86 g/cm^3).
Executive summary:

In this guideline (CFR 1500.3) study the LD0 of the test material was determined to be 5 ml/kg bw, or 4300 mg/kg bw based upon a density of 0.86 g/cm3. 5 male and 5 female rats were dosed orally by gavage at 5 mL/kg and observed for 2 weeks post-dose. No deaths were observed.