1-Dodecene, mixed with 1-decene and 1-octene, dimers, hydrogenated

Repeated dose toxicity: oral

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

Test material information

Constituent 1

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).