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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. Read-across from analogue substance (Alcohols, C18-22, distn. residues). For details please refer to the read-across report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
1160164-88-4
Cas Number:
1160164-88-4
IUPAC Name:
1160164-88-4
Constituent 2
Reference substance name:
Alcohols, C18-22, distn. residues
IUPAC Name:
Alcohols, C18-22, distn. residues
Details on test material:
- Name of test material (as cited in study report): Alcohols C18-22, distn. residues
- Substance type: pure active substance
- Physical state: solid
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Texas Animal Specialties, Humble, TX, USA
- Age at study initiation: 8 weeks
- Weight at study initiation: 163 - 176 g
- Fasting period before study: 16 hours
- Housing: 1 animal per cage in suspended, wire-bottomed, stainless steel cages
- Diet (e.g. ad libitum): PMI Feeds Inc. Formulab #5008 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 50 - 95
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 2009-09-22 To: 2009-10-15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40 % (w/v)
- Amount of vehicle (if gavage): 5.00 mL/kg
- Justification for choice of vehicle: no justification given
- Lot/batch no. (if required): no data (Parade, Exp Apr 2010)
- Purity: no data


MAXIMUM DOSE VOLUME APPLIED: 0.88 mL
Doses:
2000 mg/kg
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: Observation for mortality and clinical/behavioral signs of toxicity were made three times on the day of dosing (day 0) and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Body weights were recorded just prior to dosing and on days 7 and 14.
Statistics:
not performed

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality occurred
Clinical signs:
other: One animal showed salivation, crusting around the muzzle, and polyuria on days 0 and 1. The other animals were normal at each observation point.
Gross pathology:
no observable abnormalities were seen
Other findings:
none

Any other information on results incl. tables

Table: 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 (hours)

Number with evident toxicity(#/total)

Male

Female

Combined

Male

Female

Combined

2000

 not tested

 0/5

 0/5

 -

 not tested

 1/5

 1/5

 

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 was estimated to be greater than 2000 mg/kg bw in female albino rats.
Executive summary:

The test substance, Alcohols, C18 -22, distn. residues (CAS No.: 1160164 -88-4), was evaluated for its acute oral toxicity potential in female albino rats when administered as a gavage dose at a level of 2000 mg/kg. The study was terminated following the stopping rules of this procedure. No mortality occurred during the study. Clinical signs included salivation, crusting on muzzle, and polyuria in one animal, which were no longer evident by day 2. There was no effect on body weight gain in animals. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was estimated to be greater than 2000 mg/kg.

This result is used in a read-across approach in the REACH registration of Alcohols, C12 -18, distn. residues.