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Description of key information

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
Study period:
October until November 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: - missing test substance characterisation
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
A goal of the investigation is it to win knowledge on the sign of poisoning, the lowest toxic and the deadly dose (LD50) of 2-Octyl-Dodecanol by oral administration at rats.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: S.IVANOVAS, Kießlegg, Germany
- Age at study initiation: male 38; female 42 days
- Weight at study initiation: 100-105 g
- Fasting period before study: 15-16 hours
- Housing: single in Macrolon cages (type II)
- Diet : ALTROMIN 1323 (ad libitum)
- Water: tap water (ad libitum)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24° ± 0.5
- Humidity (%): 60 ± 3
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): not mentioned

IN-LIFE DATES: From: October 1974 To: November 1974
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 50.4 ml/kg bw
single application by gavage
Doses:
25.2, 31.8, 40.0 and 50.4 ml/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 4 weeks
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, bodyweight and fodder consumption were determined
Statistics:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 50.4 mL/kg bw
Mortality:
No animals died.
Clinical signs:
None incompatibility reaction was observed. After 20 hours no toxic symptoms was observed.
Body weight:
body weight gains were unaffected
Gross pathology:
Dissection of surviving animals at the end of the experiment showed no pathological findings.

Table 1: Mortality and number of animals with evident toxicity

 

Dose
(ml/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity (#/total)

Male

Female

Combined

Male

Female

Combined

25.2

0/10

0/10

0/20

-

0/10

0/10

0/20

31.8

0/10

0/10

0/20

-

0/10

0/10

0/20

40.0

0/10

0/10

0/20

-

0/10

0/10

0/20

50.4

0/10

0/10

0/20

-

0/10

0/10

0/20

 

Interpretation of results:
GHS criteria not met
Conclusions:
2-Octyldodecan-1-ol is practically nontoxic after oral administration of high doses to rats.
Executive summary:

2-Octyldodecan-1-ol is practically nontoxic after oral administration of high doses to rats. No mortality occured after oral administration of up to 50.4 ml/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
42 316 mg/kg bw

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

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Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October to November 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: missing test substance characterisation, reduced observation period of 7 days, no information on clinical observations and body weights
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
other: HAZARDOUS SUBSTANCES, Part 191, Section 11, FDA, Washington 1965
GLP compliance:
no
Test type:
other: Rabbits were exposed to test substance for 24 hours on intact and scarified skin. The treatment was followed by a 7-day observation period. Skin reactions, behaviour, general condition, food and water consumption and body weight gain were recorded.
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: laboratory breed
- Age at study initiation: not mentioned
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Altromin 2023, ad libitum, supplied by Altromin GmbH, Lage, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: not mentioned

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 60 ± 3
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 15 x 16 cm on the back of the animals, 3 animals per sex were treated on intact skin, 3 animals per sex were treated on abraded skin
- % coverage: 10
- Type of wrap if used: not wrapped


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water (30°C)
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.3-2.8 ml and 4.6-5.6 ml
- Constant volume or concentration used: no
Duration of exposure:
24 hours
Doses:
1 and 2 mL/kg b.w.
No. of animals per sex per dose:
3 with intact skin, 3 with scarified skin
Control animals:
other: control group (3 animals per sex with intact skin, 3 animals per sex with scarified skin) exposed with methylhydroxy ethyl Cellulose Gel 300 P, 1% in water
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: skin effects (erythema, edema) were recorded 5, 15, 30 min, 1, 2, 4, 24, 48, 72, 96, 120, 144 and 168 hours after removal of the test substance. General behaviour, food and water intake and body weight were recorded daily.
- Necropsy of survivors performed: no
- Other examinations performed: none
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 mL/kg bw
Mortality:
no mortality occured during the course of the study
Clinical signs:
only slight skin irritation noted
Body weight:
no data recorded
Gross pathology:
not performed
Other findings:
Necrosis and rhagades were not observed, growth of hair was not affected.
Interpretation of results:
GHS criteria not met
Conclusions:
2-Octyldodecan-1-ol is practically nontoxic after dermal administration to rabbits.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
1 679 mg/kg bw

Additional information

Experimental studies of 5 representatives of the category of Guerbet alcohols show a very low acute oral toxicity. Mortalities were only observed after application of the shortest chain Guerbet alcohol 2 -Butyl-octan-1-ol (C12) but only at doses of about 15,000 mg/kg bw and above. No clinical symptoms were observed for Alcohols C16 -20, branched and longer chain guerbet alcohols after application of very high doses. No pathological findings were observed at dissection of the animals.

Acute dermal toxicity studies of C16 and C20 Guerbet alcohol also show a low dermal toxicity at doses of up to 2 ml/kg. The test substances were applied on intact as well as on scarificed skin with a damaged skin barrier. No deaths occurred at any of the doses applied. In case of the experiment with scarificed skin it should be considered that doses systemically available were actually much higher.

Based on the available data it can be concluded that all Guerbet alcohols of the category are of very low acute oral and dermal toxicity.

Justification for classification or non-classification

Available data are conclusive but not sufficient for classification of 2 -octyldodecan-1-ol with regard to acute toxicity.