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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The acute oral toxicity key study reports an LD50 value of >15800 mg/kg in rat in a reliability 2 study (Younger Labs 1972). The inhalation key study reports and LC50 value of 700 mg/m³ air in response to a 6 hour exposure (Younger Labs 1972), which is the only available information for the inhalation endpoint. The rabbit acute dermal LD50 value was reported to be >5010 mg/kg (Younger Labs 1972).

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Screening test with basic information and result reporting. Appears valid.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The observation period was 7 days, and animals per dose was not according to guideline.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 215-260g
Route of administration:
oral: gavage
Vehicle:
other: undiluted
Details on oral exposure:
No detail available.
Doses:
5010 mg/kg, 7940 mg/kg, 12600 mg/kg, 15800mg/kg
No. of animals per sex per dose:
5010mg/kg; 1F, 7940mg/kg; 1F, 12600mg/kg; 1F, 15800mg/kg; 3M, 2F.
Control animals:
not specified
Details on study design:
Observations were made for toxic signs and the viscera of the test animals were examined macroscopically. Observation period 7 days.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 800 mg/kg bw
Based on:
test mat.
Mortality:
No animals died.
Clinical signs:
other: Toxic signs included reduced appetite and activity and lethargy lasting two to three days.
Gross pathology:
Surviving animals were sacrificed seven days after dosing. The viscera appeared normal by macroscopic examination.
Interpretation of results:
GHS criteria not met
Conclusions:
The rat oral LD50 for undecyl alcohol was >15800 mg/kg. The study was not conducted according to GLP and the observation period was 7 days.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 800 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
Study period:
1972
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Observation period was 10 days.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
Average temperature inside chamber: 78F
Average relative humidity inside chamber: 80%
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
The rats were placed in a stainless steel chamber of 35 litres capacity and exposed to a concentrated atmosphere of vapours produced by passing a stream of air through 130.5 grams of the compound contained in a 300 milliliter flask. The sample was maintained at a temperature of 100C by immersing flask in heated sand bath. Vapours from the flask passed into one litre bottle to remove droplets and then into the chamber. Air flow through tthe sample was 4.0 litres per minute as measured by a calibrated rotameter. This was sufficient to violently agitate the liquid. No supplementary air was introduced inasmuch as the above supply was ample for the animals oxygen requirements.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
6 h
Concentrations:
0.4 mg/l
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
The animals were observed for behaviour during exposure and for ten days following exposure. The viscera of the animals were examined macroscopically.
Sex:
male
Dose descriptor:
LC50
Effect level:
> 700 mg/m³ air
Exp. duration:
6 h
Mortality:
There were no deaths during the exposure or the 10 days observation period.
Clinical signs:
other: Upon removal from the chambre the fur was roughened; respiration was normal and no other signs of toxic distress were noted.The ten day observation period was uneventful.
Body weight:
The weight gain was normal.
Gross pathology:
The viscera appeared normal by macroscopic examination.
Interpretation of results:
GHS criteria not met
Conclusions:
Rat 6 hour LC50 was reported to be >700mg/m3 air. The study was equivalent to guideline. The result was read across from undecan-1-ol (CAS 112-42-5).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
700 mg/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:
comparable to guideline study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The undiluted compound was applied in increasing doses at increments of 0.2 fractional log intervals to the closely clipped, in tact skin of male/female rabbits.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 1.8-2.5kg

- Housing: individual cages
Type of coverage:
occlusive
Vehicle:
other: undiluted
Details on dermal exposure:
Test material was applied to intact skin.
Duration of exposure:
24 hours
Doses:
3160, 5010 and 7940 mg/kg
No. of animals per sex per dose:
3160 mg/kg; 1F, 5010mg/kg; 1M, 7940 mg/kg;1M, 1F.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 010 - < 7 940 mg/kg bw
Based on:
test mat.
Mortality:
A female rabbit died at 7940mg/kg dose level on day 4.
Clinical signs:
other: Reduced appetite and activity and lethargy (three to five days in survivors), increasing weakness, collapse and death.
Gross pathology:
At necropsy there was slight lung congestion, liver discolouration, enlarged gall bladder and slight gastrointestinal inflammation. Surviving animals were sacrificed 14 days after dosing. The viscera appeared normal by macroscopic examination.
Interpretation of results:
GHS criteria not met
Conclusions:
The rabbit acute dermal LD50 was reported to be > 5010 mg/kg (but <7940 mg/kg). The study was not compliant with GLP.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 010 mg/kg bw

Additional information

The key inhalation data from Younger Labs (1972) was the best data available for this endpoint.

The highest average concentration in the test chambre is reported to be 700 mg/m3. The saturated vapour concentration calculated using the ideal gas equation on the basis of the physiocemical properties of undecan-1 -ol implies that the highest theoretically achievable vapour concentration for undecanol is less then the reported value of 700mg/m3. Therefore the recorded concentration in the key study represents the highest possible exposure concentration and can be considered for classification purposes. In order to support the key result, a read across is included from the structurally analogous substance 1 -decanol which reports an acute inhalation LC50 value of >71 mg/l (mist) (Scientific Associates, 1977).

All the reliability 3 and 4 supporting studies support the findings of the key studies by the Younger Labs, although the available information in the supporting studies was not sufficient for determining classification.The key study report by the Younger Laboratories (1972) was the most recent and high reliability source available, which was premise for its allocation as the key study.

Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:

Acute toxicity tests of the linear and essentially linear alcohols do not indicate any potential hazard for acute, dermal or inhalation toxicity. The available data for the Category have been reviewed with the conclusion that the long chain alcohols are of a low order of acute oral and dermal toxicity, and the inhalation LC50 is expected to be greater than the substantially saturated vapour concentration (Veenstra G, Webb C et al., 2009). Tests on various substances included in this category are all supportive of these results and do not warrant classification for most of the acute toxicity endpoints under GHS criteria. The majority of the substances are therefore not classified for acute toxicity in accordance with Regulation (EC) No 1272/2008. The only exception to this is hexan-1-ol, which finds that the acute dermal data for the test substance are consistent with Acute dermal tox category 4 and Acute oral tox 4 H302/R22, in line with the Annex VI entry. A full discussion of the Category can be found in the Human Health Alcohols C6-24 Category report (PFA, 2016).

Justification for classification or non-classification

Based on the available information, undecan-1 -ol is concluded not to need classification or labelling for the acute toxicity endpoints, in accordance with CLP (EC regulation 1272/2008).