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Diss Factsheets

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:
23 Oct - 15 Nov 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2004
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Docosyl docosanoate
EC Number:
241-646-5
EC Name:
Docosyl docosanoate
Cas Number:
17671-27-1
Molecular formula:
C44H88O2
IUPAC Name:
docosyl docosanoate
Test material form:
solid

Test animals

Species:
rat
Strain:
other: HanRcc: WIST(SPF)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Füllinsdorf, Switzerland
- Age at study initiation: 11 weeks
- Fasting period before study: approx. 17 - 18 h
- Housing: Groups of three animals in Makrolon Type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel', Schill AG, 4132 Muttenz, Switzerland)
- Diet: Provimi Kliba 3433 rat/mouse maintenance diet, batch nos. 23/07 and 41/07 (Provimi Kliba AG, 4303 Kaiseraugst, Switzerland), ad libitum
- Water. Community tap water from Füllinsdorf, ad libitum
- Acclimation period: Under laboratory conditions after health examination, period not specified
- Method of randomisation in assigning animals to test and control groups: Selected by hand at time of delivery, no computer generated randomisation program used

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 30 Oct 2007 To: 15 Nov 2007

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG-300
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: Based on solubility test performed prior to toxicity study
- Lot/batch no.: 1310049
- Purity: Not specified

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: No toxicity was expected, hence, 2000 mg/kg bw was chosen as starting dose.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2 groups of 3 females each
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Daily during the acclimatisation period, during the first 30 min and at approx. 1, 2, 3 and 5 h after administration, twice daily during Days 2 - 15 (clinical signs only once daily).
- Weighing: On test Days 1 (prior to administration), 8 and 15

- Necropsy of survivors performed: yes
Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: Within the first 30 min after administration slightly ruffled fur was noted in three out of the six treated females that persisted up to the 3 h observation. In one further female slightly ruffled fur was noted only at the 3 h observation.
Gross pathology:
Macroscopic examination revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
In this acute oral toxicity study in female rats a LD50 value of > 2000 mg/kg bw was determined.