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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1970-05-21- to 1970-06-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP study, similar to OECD Guideline. For justification of read across see section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Oleic acid
EC Number:
204-007-1
EC Name:
Oleic acid
Cas Number:
112-80-1
Molecular formula:
C18H34O2
IUPAC Name:
octadec-9-enoic acid
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Fasting period before study: 24 hours
- Weight at study initiation: 200-300 g
- Housing: 5 animals per cage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
4, 8, 16, 32, 48, 64 mL/kg, these values correlate to the following: 5262.125, 10524.25, 21048.5, 42097, 63145.5, 84194 mg/kg bw
No. of animals per sex per dose:
5 animals per dose including both male and female animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
32 mL/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
47.3 mL/kg bw
Based on:
test mat.
95% CL:
> 40.9 - < 54.7
Remarks on result:
other: 47.3 mL/ kg bw can be converted to 42097 mg/kg bw using the densitiy of the substance (0.89 g/cm^3 = densitiy of CAS 112- 80-1)
Sex:
male/female
Dose descriptor:
LD100
Effect level:
64 mL/kg bw
Based on:
test mat.
Mortality:
Mortality occured from the 40 mL/kg bw dose group onwards. 1 animal of that dose group died on day 2, 3 animals of the 48 mL/kg bw dose group and all animals of the 64 mL/kg bw dose group died on day 1.
Clinical signs:
All dosage levels from 16 mL/kg and above had nasal hemorrhage, crustated occular areas, oozed urine and appeared to be debilitated prior to death.
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion