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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited documentation but acceptable for assessment. read across to the registered substance is considered scientifically justified.

Data source

Reference
Reference Type:
publication
Title:
No information
Author:
Hachiya N, Takeya A, Takizawa Y
Year:
1982
Bibliographic source:
Japanese J. Public Health 29(5): 236-239. (In Japanese, translation available)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Principles of method if other than guideline:
Method: other: mouse bone marrow micronucleus test to protocol to the Japanese Labour Ministry
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Octadecanol (112-92-5) (Kalcohol 80, 718)

Test animals

Species:
mouse
Strain:
other: ddY
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Vehicle used: olive oil
Duration of treatment / exposure:
24 hours
Frequency of treatment:
single administration and 4 administrations
Post exposure period:
24 hours (single administration); 5 days from initial administration (repeat administration)
Doses / concentrations
Remarks:
Doses / Concentrations:
360, 730, 1450 mg/kg (single dose) or 730 mg/kg (adminstered 4 times in 24 hours)
Basis:

No. of animals per sex per dose:
6 (single dose) 5 (repeat dose) sex not stated
Control animals:
yes, concurrent vehicle
Positive control(s):
- Positive control: mitomycin C
- Route of administration: ip injection
- Doses / concentrations: 3.0 mg/kg

Examinations

Tissues and cell types examined:
Bone marrrow; erythrocytes examined

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
MORTALITY: Not reported CLINICAL SIGNS: Not reported NECROPSY FINDINGS: Not reported BODY WEIGHT CHANGES: Not reported FOOD AND WATER CONSUMPTION CHANGES:  Not reported EFFECT ON MITOTIC INDEX OR PCE/NCE RATIO: There were no effects on the incidence of reticulocytes following a single dose of stearyl alcohol. 
Repeated exposure showed a decrease [controls 61.3%; treated 52.9%] GENOTOXIC EFFECTS: No significant increase increase in numbers (%) of micronucleated erythrocytes. 10000 - 12000 observed. NOAEL (NOEL) (C) / LOAEL (LOEL) (C): A single dose of 1450 mg/kg/day or a total repeated dose of 2920 mg/kg did not increase the incidence of 
micronuclei. There was no reported assessment of effects on the live animals.

Any other information on results incl. tables

Results of micronucleus assay

Treatment

Vehicle 25 ml/kg

Positive control 3.0 mg/kg

Low dose
0.36 g/kg

Mid dose
0.73 g/kg

High dose
1.45 g/kg

Mid dose
0.73 g/kg

No of injections

1

1

1

1

1

4

Micronucleated erythrocytes %

0.13 ±0.10

1.96 ± 0.64

0.03 ± 0.03

0.06 ± 0/04

0.09 ± 0.04

0.08 ± 0.08

Frequency of erythrocytes

81.3 ± 8.0

46.2 ± 9.4

61.5 ± 6.2

60.3 ± 9.2

67.4 ± 7.5

52.9 ± 7.6

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Stearyl alcohol (Kalcohl 80, 718) did not increase the incidence of micronucleated cells in mouse bone marrow erythrocytes following a single oral dose level up to and including 1450 mg/kg or a total of 2920 mg/kg adminstered as 4 doses in a 24 hour period. It is concluded that the test substance is negative for induction of micronuclei under the conditions of the test.