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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Study period:
02 Feb - 02 Mar 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Fatty acids, C8-24
EC Number:
275-164-1
EC Name:
Fatty acids, C8-24
Cas Number:
71076-48-7
Molecular formula:
C8H16O2 - C24H48O2
IUPAC Name:
71076-48-7
Details on test material:
- Name of test material (as cited in study report): Polyresidal F (FS 017) (destillation residue of unsaturated fatty acids)
- Physical state: pasty
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 171 g (males), 161 g (females)
- Fasting period before study: 16 h prior to administration (diet only)
- Housing: 5 animals of the same sex per cage in Makrolon 3 cages on soft wood resin
- Diet: Altromin Feeding diet 1324 (Fa. Altromin GmbH, Lage , Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 to 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% (g/v)
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw


Doses:
2000 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: Observations were made several times on the day of application, then animals were observed twice per day. Body weight was determined on the day prior to administration, on the day of administration (fasted) and 48 h, 7 and 14 days thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
No effect on body weight was noted. Mean body weights (g) on day before administration/day 0/day 2/day 7/day 14:
- males: 182/171/191/213/244
- females: 171/161/175/177/185
Gross pathology:
In one female, a moderate hydrometra was observed which is not assumed to be substance-specific. Otherwise, necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified