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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1994-12-05 to 1995-01-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to or similar to study guidelines (OECD 407 / Method B7 67/549/EEC Directive) : GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Version / remarks:
and Method B7 (67/548/EEC Directive)
GLP compliance:
yes (incl. QA statement)
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of isomers of branched tetracosane
EC Number:
417-060-2
EC Name:
A mixture of isomers of branched tetracosane
Cas Number:
151006-61-0
Molecular formula:
C24H50
IUPAC Name:
Hydrogenated dimerization products of 1-dodecene
Constituent 2
Reference substance name:
1-DODECENE DIMER, HYDROGENATED
IUPAC Name:
1-DODECENE DIMER, HYDROGENATED

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
28 days
Frequency of treatment:
Single oral gavage daily of undiluted neat material for 28 consecutive days
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1000 mg/kg bw/day
Basis:

No. of animals per sex per dose:
10 animals (5 male/5 female) per treatment group
Dose levels 0 and 1000 mg/kg/day (limit dose)
Two additional satellite groups were similarly dosed at 0 and 1000 mg/kg for 28 days and then allowed to recover for 2 weeks before being euthanized and necropsied.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed

Effect levels

Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day (actual dose received)
Sex:
male/female
Basis for effect level:
other: limit dose

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOAEL for the test material orally administered to rats for 28 days is greater than or equal to 1000 mg/kg body weight /day (limit dose)
Executive summary:

Groups of five Sprague-Dawley rats of each sex were orally dosed by gavage with undiluted 1-dodecene dimer, hydrogenated test material for 28 consecutive days at the following dose levels: 0 mg/kg and 1000mg/kg (limit test).  Two additional satellite groups were similarly dosed with 0 and 1000mg/kg/day and allowed to recover for two weeks after 28 days of dosing before being sacrificed.  No mortality or treatment-related clinical signs were observed in the test or control animals throughout the study. There were no changes in body weight gain, food consumption, hematology, or clinical chemistry.  Organ weights were not affected by treatment.  No treatment-related histopathological changes were observed in the examined tissues of the treated animals at time of necropsy. The NOAEL is therefore considered to be greater than or equal to 1000 mg/kg bw /day in orally exposed rats for 28 days (limit dose).

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