Registration Dossier

Toxicological information

Acute Toxicity: oral

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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
Study period:
1984-05-30 - 1984-06-20
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well conducted study similar to guideline (limited documentation; limit test at ca. 4250 mg/kg bw)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
limit test at ca. 4250 mg/kg bw, limited documentation
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, 2-hexyldecyl esters
EC Number:
309-832-1
EC Name:
Fatty acids, C16-18, 2-hexyldecyl esters
Cas Number:
101227-09-2
IUPAC Name:
101227-09-2
Details on test material:
- Name of test material (as cited in study report): Isohexadecylstearat
No further details provided

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 201.8 g (after fasting)
- Fasting period before study: 17 hours
No additional details provided.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
Doses:
5 mL/kg bw (corresponding to ca. 4250 mg/kg bw, calculated assuming test substance density of 0.85 g/cm3)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
No further details provided.
Statistics:
Not applicable

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 4 250 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred at this unique dose level (original value: 5 mL/kg bw; converted assuming test substance density of 0.85 g/cm3).
Mortality:
No mortality was observed.
Clinical signs:
Slight piloerection and slight reduced activity were observed up to 1 hour after treatment. All treated animals appeared normal thereafter.
Body weight:
No adverse effects were reported.
Gross pathology:
No abnormalities were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information