Reaction mass of 2-Hexyl-1-dodecanol and 2-Octyl-1-decanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1986

Reliability:

2 (reliable with restrictions)

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

Test material information

Constituent 1

Reference substance name:

Alcohols, C16-20-branched

EC Number:

274-758-8

EC Name:

Alcohols, C16-20-branched

Cas Number:

70693-04-8

Molecular formula:

not applicable, UVCB

IUPAC Name:

Alcohols, C16-20-branched

Details on test material:

- Name of test material (as cited in study report): Isofol 18
- Lot/batch No.: 12046
- specific gravity: 0.846 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: 40 - 50 days
- Weight at study initiation: 150 - 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: October 1986

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 46.4 ml/kg bw
single application by gavage

Doses:

32402 and 39255 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 levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 39 255 mg/kg bw

Based on:

test mat.

Mortality:

Time of death: none

Clinical signs:

other: none incompatibility reaction was observed

Gross pathology:

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
32402	0/5	0/5	0/10	-	0/5	0/5	0/10
39255	0/5	0/5	0/10	-	0/5	0/5	0/10

 

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study alcohols 16-20, branched are practically nontoxic after oral administration to rats.

Executive summary:

Based on the results of this study alcohols 16-20, branched are practically nontoxic after oral administration to rats.