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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:
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 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:
Increasing weakness, diarrhea, collapse.
Body weight:
Weight loss (two to six days in survivors).
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:
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 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:
No data
Body weight:
No data
Gross pathology:
No data
Interpretation of results:
GHS criteria not met

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

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