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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

- acute oral:
   rat (male/female): LD50 = 5400 mg/kg bw (TSCAT, OTS 0538594, Doc I.D. 88-920007511, Monsanto Company, 1979; reliable with restrictions)
- acute inhalative:
   rat (male/female): IRT, no mortality after the 8 hour-exposure to saturated vapor (at 20°C) (Smyth, H.F. et al., 1962; reliable with restrictions)
- acute dermal:
   rabbit (male/female): LD50 > 5100 mg/kg bw (TSCAT, OTS 0538594, Doc I.D. 88-920007511, Monsanto Company, 1979; reliable with restrictions)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Principles of method if other than guideline:
Administration of a single oral dose of the test substance to Sprague-Dawley rats to determine the acute oral 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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 235 - 250 g, females: 235-245 g;
Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
5010, 6310, 7940, 10000 mg/kg
No. of animals per sex per dose:
5 animals per dose (males and females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 400 mg/kg bw
Based on:
test mat.
95% CL:
>= 5 020 - <= 5 780
Mortality:
- 5010 mg/kg bw: males: 0/2, females: 1/3;
- 6310 mg/kg bw: males: 3/3, females: 2/2;
- 7940 mg/kg bw: males: 2/2, females: 3/3;
- 10000 mg/kg bw: males: 3/3, females: 2/2;

Deaths occurred between days 2 - 5
Clinical signs:
other: Increasing weakness, ocular discharge, diarrhea, collapse
Gross pathology:
Decedents: Hemorrhagic lungs, liver discoloration, and acute gastrointestinal inflammation;
Survivors: Viscera appeared normal;
Interpretation of results:
GHS criteria not met
Conclusions:
According to the results of the study a LD 50 value of 5400 mg/kg bw was established under these test conditions. Therefore no classification according to EU or GHS criteria is required.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 400 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.
Principles of method if other than guideline:
Concentrated vapor inhalation was performed exposing groups of 6 male or female albino rats to a flowing stream of vapor-loaded air. The vapor-air mixture was generated by passing 2.5 l/min of dried air at room temperature through a fritted glass disc immersed to a depth of at least one inch in approximately 50 ml of the test substance in a gas-washing bottle. Inhalations were continued for 8 hours in a logarithmic series. The observation period lasted 14 days.
GLP compliance:
no
Test type:
other: inhalation risk test
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-Propylheptanol
- Analytical purity: not stated
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Source and rate of air: 2.5 l/min
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
0.130 mg/l (vapor saturation)
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Sex:
male/female
Dose descriptor:
LC0
Effect level:
ca. 0.13 mg/L air
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: IRT: the test concentration (saturated vapor) was calculated by means of the vapor pressure at 20°C and the molecular weight
Mortality:
No mortality after 8 hours exposure.
Clinical signs:
other: no data
Body weight:
no data
Gross pathology:
no data
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
0.13 µg/m³ air

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
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, 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
Conclusions:
According to the results of the study a LD 50 value > 5010 mg/kg bw was established under these test conditions. Therefore no classification according to EU or GHS criteria is required.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 010 mg/kg bw

Additional information

Oral:

Acute oral toxicity was evaluated in a study which was reliable with restrictions. Groups of 5 male and 5 female Sprague-Dawley rats received doses of 5010, 6310, 7940 or 10000 mg/kg bw of 2-Propylheptan-1-ol (TSCAT, OTS 0538594, Doc I.D. 88-920007511, Monsanto Company, 1979). Clinical signs included: increasing weakness, ocular discharge, diarrhea, collapse. Due to the observed mortality (2 - 5 days after administration) LD50 of 5400 mg/kg bw (male and female animals) was estimated.

Inhalative:

 

Data of the acute inhalative toxicity of CAS 10042-59-8 is restricted to an inhalation risk test (reliable with restrictions) with limited reporting (Smyth, H.F. et al., 1962).

Concentrated vapor inhalation was performed exposing groups of 6 male or female albino rats to a flowing stream of vapor-loaded air. The temperature at vapor generation was room temperature.

Vapor saturation at 20°C is 0.130 mg/l (vapor pressure (20°C): 0.02 hPa). Inhalations were continued for 8 h. The observation period lasted 14 days. After the 8 hour-exposure no mortality occurred. No information on clinical signs was given.

Dermal:

 

Acute dermal toxicity was analyzed in a study (reliable with restrictions), where New Zealand White rabbits received a dermal application of 3160 (1 male animal), 5010 (1 female animal) or 7940 mg/kg bw (1 male and 1 female animal) of 2-Propylheptan-1-ol for 24 hours (TSCAT, OTS 0538594, Doc I.D. 88-920007511, Monsanto Company, 1979). Clinical signs were: increasing weakness, diarrhea, collapse. Only the male animal of the 7940 mg/kg bw group died. Therefore, a LD 50 > 5010 mg/kg bw was established.

All described studies were conducted before the implementation of GLP and OECD Guidelines.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.