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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See justification attached to IUCLID chapter 13.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Principles of method if other than guideline:
Application of a single dermal dose of the test substance to the skin of male and female New Zealand Albino Rabbits for 24 h to determine the acute dermal toxicity.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-Propylheptanol
- Lot/batch No.: NBP 1282594-A
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 1.8 kg, females: 1.9 - 2.0 kg
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
3160, 5010 and 7940 mg/kg bw
No. of animals per sex per dose:
- 3160 mg/kg: 1 male animal;
- 5010 mg/kg bw: 1 female animal;
- 7940 mg/kg bw: 1 male and 1 female animal;
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 010 mg/kg bw
Based on:
test mat.
Mortality:
- 3160 mg/kg bw: 0/1 (male animal);
- 5010 mg/kg bw: 0/1 (female animal);
- 7940 mg/kg bw: male animal: 1/1; female animal: 0/1;

Deaths occurred on day 2.
Clinical signs:
other: Increasing weakness, diarrhea, collapse.
Gross pathology:
Decedents: Hemorrhagic areas of the lungs, liver and spleen discoloration, enlarged gall bladder, darkened kidneys, and gastrointestinal inflammation;
Survivors: Viscera appeared normal;
Interpretation of results:
GHS criteria not met
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Scientifically valid. Adopted according to OECD SIDS (public available peer reviewed source).
Principles of method if other than guideline:
The LD50 was determined by a method closely akin to the one-day cuff method of Draize et al. (1944) using groups of 4 male albino New Zealand rabbits. The fur was removed by clipping and the dose was retained beneath an impervious plastic film (i.e. occlusive). The animals were immobilized/exposed for 24 hours. Afterwards, the film was removed and the animals were observed for 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Tridecanol (mixed primary isomers)
- Analytical purity: not stated
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg
Type of coverage:
occlusive
Vehicle:
not specified
Duration of exposure:
24 h
Doses:
No data
No. of animals per sex per dose:
4 male animals
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 14 days
Statistics:
LD50 value and its confidence interval was estimated by the method of Thompson (1947) using the tables of Weil (1952).
Sex:
male
Dose descriptor:
LD50
Effect level:
7.07 mL/kg bw
Based on:
test mat.
95% CL:
>= 2.33 - <= 21.4
Remarks on result:
other: = ca. 5960 mg/kg bw, confidence interval: 1964 - 18040 mg/kg bw, calculated by the density of 843 g/L)
Mortality:
No data
Clinical signs:
other: No data
Gross pathology:
No data
Interpretation of results:
GHS criteria not met

Data source

Materials and methods

Test material

Constituent 1
Reference substance name:
Alcohols, C13-15-branched and linear
EC Number:
287-625-4
EC Name:
Alcohols, C13-15-branched and linear
Cas Number:
85566-16-1
Molecular formula:
C13 H27 OH - C15 H31 OH
IUPAC Name:
Alcohols C13-C15 branched and linear, reaction products of C12-C14 olefines

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
5 960 mg/kg bw
Remarks on result:
other: as determined from read-across CAS 27458-92-0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met