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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

repeated dose toxicity: oral
Adequacy of study:
other information

Data source

Reference Type:
other: Body responsible for the test

Materials and methods

Test guideline
according to guideline
other: OECD 407 (1981)
GLP compliance:
Limit test:

Test animals

other: rat, Wistar Hoe:WISKf (SPF 71)

Administration / exposure

Route of administration:
oral: unspecified
other: Sesamöl "ENGLISH" sesame oil
Details on oral exposure:
Method of administration:
Magensonde (by gavage)
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 30 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 750 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 30 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 750 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
Es traten weder vorzeitige Todesfälle noch Anzeichen für
klinische Toxizität auf. Futter- und Wasseraufnahme sowie
Gewichtsentwicklung entsprachen den Kontrollwerten.


Neither premature mortalities nor signs of clinical toxicity
occurred. The feed and water intake as well as the weight
development corresponded to that of the controls.

Laboratory findings:
Hämatologisch zeigten sich keine Veränderungen.
Klinisch-chemisch wurden Schwankungen einiger Meßparameter
beobachtet, die aber weder signifikant unterschiedlich noch
dosiswirkungsspezifisch waren und somit toxikologisch nicht
relevant bewertet wurden.


Haematologically, there were no changes.

Clinico-chemically, there was some variance in a few
measurement parameters. However, this was neither
significantly different nor dose-specific. Consequently, it
was not regarded as toxicologically relevant.

Effects in organs:
Morphologisch ergaben sich keine substanzbedingten
pathologischen Befunde.


Morphologically, there were no substance-related
pathological findings.

Effect levels

Dose descriptor:
Effect level:
750 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Classified as: Not classified