Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
February - March 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This is a GLP guideline study and is used in read-across from Alchisor CAL 123 (see 'Read Across Justification Document'). The study merits a Klimisch 1 rating; Klimisch 2 when used for read-across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
yes
Remarks:
Humidity was outside protocol range but did not affect study outcome.
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Alkenes, C11-12, hydroformylation products, distn. residues; Alchisor CAL (Commercial Name)
- Substance type: pure active substance
- Physical state: colourless liquid
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Texas Animal Specialties, Humble, TX, USA
- Age at study initiation: 8 weeks
- Weight at study initiation: 180 - 210 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): 21 - 24
- Humidity (%): 25 - 67 (humidity was outside protocol range)
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 2010-02-16 To: 2010-03-12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 0.47 mL
Doses:
2000 mg/kg (2.36 mL/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:
all animals appeared normal for the duration of the study
Body weight:
body weight gain was unaffected by the administration of the test substance
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

 0/5

 0/5

 

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, Alkenes, C11 -12, hydroformylation products, distn. residues (CAS No.: 90622 -27 -8), 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. There were no clinical signs of toxicity during the study. Animals exhibited weekly weight gain during the study. 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.