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Toxicological information

Acute Toxicity: oral

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Octyl-dodecanol
no more details mentioned

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels
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.

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

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.