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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 1986
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butyloctan-1-ol
EC Number:
223-470-0
EC Name:
2-butyloctan-1-ol
Cas Number:
3913-02-8
Molecular formula:
C12H26O
IUPAC Name:
2-butyloctan-1-ol
Details on test material:
- Name of test material (as cited in study report): Isofol 12
- specific gravity: 0.845 g/l
no more details mentioned

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht, Extertal, Germany
- Age at study initiation: 52 - 60 days
- Weight at study initiation: 156 - 168 g
- Fasting period before study: 15 - 16 hours
- Housing: single in Macrolon cages (type III)
- Diet : ALTROMIN 1324 (ad libitum)
- Water: tap water (ad libitum)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21° ± 1
- Humidity (%): 55 ± 5
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: October 1986 To: November 1986

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 47.9 ml/kg bw
single application by gavage
Doses:
10225 / 15041 / 22055 / 32363 / 39208 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- 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 levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
26 533 mg/kg bw
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
37 434 mg/kg bw
Mortality:
Time of death: 8-24 h after dosing at the earliest and 3 days after dosing at the latest.
Clinical signs:
The signs were observed: reduced motility, hypopnoeam, reduced food consumption (15041 mg/kg), pultaceous faeces (22055 mg/kg), dyspnoea (32363 mg/kg). Surviving animals recovered within 2 - 3 days after administration.
Body weight:
body weight gains were unaffected.
Gross pathology:
Post mortem dissection revealed cloudy bright liver, redness intestine. Dissection of surviving animals at the end of the experiment observed none pathology findings.

Any other information on results incl. tables

Table 1: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths

Number with evident toxicity (#/total)

Male

Female

Combined

Male

Female

Combined

10225

0/5

0/5

0/10

-

0/5

0/5

0/10

15041

0/5

3/5

3/10

8 - 30 h

5/5

2/2

7/7

22055

1/5

3/5

4/10

1 - 2 d

4/4

2/2

6/6

32363

1/5

4/5

5/10

1 - 3 d

4/4

1/1

5/5

39208

2/5

3/5

5/10

8 h - 2 d

3/3

2/2

5/5

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
2-Butyloctan-1-ol is practically nontoxic after oral administration to rats with an LD50 of 26533 mg/kg bw for females and 37434 mg/kg bw for males.
Executive summary:

2-Butyloctan-1-ol is practically nontoxic after oral administration to rats with an LD50 of 26533 mg/kg bw for females and 37434 mg/kg bw for males.