Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, calcium salts and Montan wax

Carcinogenicity

Administrative data

Endpoint:

carcinogenicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented publication which meets basic scientific principles (similar to OECD guideline 451 with some deviations), for justification of read-across see Chapter 1 of CSR

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 451 (Carcinogenicity Studies)

Deviations:

yes

Remarks:

: only two dose groups, slight food restriction after growth period

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

142583-61-7

Cas Number:

142583-61-7

IUPAC Name:

142583-61-7

Constituent 2

Reference substance name:

Policosanol

IUPAC Name:

Policosanol

Details on test material:

- Name of test material (as cited in study report): Policosanol, trade name Ateromixol
- Analytical purity: quality criteria were controlled
- Lot/batch No.: L-C-20
- Stability under test conditions: stable

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: acacia gum/water (10 mg/ml)

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

24 months

Frequency of treatment:

daily

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0 mg/kg bw/day
Basis:
other: vehicle control

Doses / concentrations 2

Remarks:

Doses / Concentrations:
50 mg/kg bw/day
Basis:
actual ingested

Doses / concentrations 3

Remarks:

Doses / Concentrations:
500 mg/kg bw/day
Basis:
actual ingested

No. of animals per sex per dose:

55

Control animals:

yes, concurrent vehicle

Results and discussion

Results of examinations

Relevance of carcinogenic effects / potential:

Based on the results of this study there is no carcinogenic potential of the test substance policosanol

Effect levels

Dose descriptor:

NOAEL

Effect level:

500 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

other: no carcinogenic effects observed

Remarks on result:

other: Effect type: carcinogenicity (migrated information)

Any other information on results incl. tables

No treatment related effects were observed with respect to survival, body weight gain, food consumption, clinical symptoms and organ weights. No significant differences were observed in malignant and benign tumours between treated groups controls. No rare tumours which are not common in this rat strain were observed.

Applicant's summary and conclusion

Conclusions:

The chronic oral treatment in doses up to 500 mg/kg bw/day did not produce carcinogenic effects in rats.

Executive summary:

The test substance (Policosanol) was administered to Sprague-Dawley rats (55 per sex and dose) by oral gavage in daily doses of 0, 50 and 500 mg/kg bw/day for 24 months. No treatment related effects were observed with respect to survival, body weight gain, food consumption, clinical symptoms, organ weights, and carcinogenic effects.