Glycerides, mixed decanoyl and octanoyl

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions. Report does not contain all study details.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

yes

Remarks:

: lack of cytotoxicity data

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Castor oil

EC Number:

232-293-8

EC Name:

Castor oil

Cas Number:

8001-79-4

IUPAC Name:

8001-79-4

Details on test material:

- Name of test material (as cited in study report): Castor Oil
- Synonyms: Ricinus Oil, oil of Palma Christi, tangantangan oil, phorboyl, Neoloid
- Composition of test material, percentage of components: Triglyceride of fatty acids. Fatty acid composition is approximately 87% ricinoleic,
7% oleic, 3% linoleic, 2% palmitic, 1% stearic, and trace amounts of dihydroxystearic.
- Analytical grade: USP AA grade
- Source: Cas Chemical, Inc. (Bayonne, NJ, USA)
- Stability: The stability of the study material during the toxicology studies was monitored by determination of peroxide content and by high performance liquid chromatography. No deterioration of the castor oil study material was observed over the course of the studies.

Method

Target gene:

Not applicable.

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Details on mammalian cell type (if applicable):

no data

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9 mix + cofactors

Test concentrations with justification for top dose:

0, 1600, 3000, 5000 µg/mL

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
Chinese hamster ovary cells were incubated with study compound or solvent (dimethylsulfoxide).

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

Migrated to IUCLID6: mitomycin C (-9); cyclophosphamide (+S9)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium;

DURATION
- Exposure duration: 10 h without S9, 2 h with S9

SPINDLE INHIBITOR (cytogenetic assays): colcemid
STAIN (for cytogenetic assays): Giemsa

Cells were arrested in first metaphase by addition of colcemid and harvested by mitotic shake off, fixed, and stained
in 6% Giemsa.

In the absence of S9, cells were incubated with study compound or solvent for 10 h at 37°C. Cells were then
washed and fresh medium containing colcemid was added for an additional 3 h followed by harvest.

In the presence of S9, cells were incubated with study compound or solvent for 2 h at 37°C. Cells were then
washed, medium without test compound was added, and incubation was continued for 10 h. Colcemid was added
for the last 3 h of incubation before harvest. S9 was from the livers of Aroclor 1254-induced male Sprague Dawley
rats.

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

Castor oil did not induce chromosome aberrations in Chinese hamster ovary cells treated with concentrations up to 5000 mg/mL with and without S9 mix.

Any other information on results incl. tables

Table 1:Summary of results of the chromosome aberration study with Castor oil*

 

	S9	Harvest time (h)	Conc. in μg/mL	Cells scored	No of aberrations	Aberrations /Cell	Percent Cells with aberrations
DMSO	-	12		200	2	0.01	1.0
Test item	-	12	1600	200	1	0.01	0.5
Test item	-	12	3000	200	2	0.01	1.0
Test item	-	12	5000	200	1	0.01	0.5
Pos. control (MMC)	-	12	0.0625	200	48	0.24	15.5
DMSO	+	13		200	3	0.02	1.5
Test item	+	13	1600	200	4	0.02	2.0
Test item	+	13	3000	200	4	0.02	2.0
Test item	+	13	5000	200	3	0.02	1.5
Pos. control (CP)	+	13	2.5	200	44	0.22	16.0

MMC = Mitomycin C

CP = Cyclophosphamide

*In the absence of S9, cells were incubated with study compound or solvent for 10 h at 37°C. Cells were then washed and fresh medium containing colcemid was added for an additional 3 h followed by harvest. In the presence of S9, cells were incubated with study compound or solvent for 2 h at 37°C. Cells were then washed, medium without test compound was added, and incubation was continued for 10 h. Colcemid was added for the last 3 h of incubation before harvest.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative Castor oil did not induce chromosome aberrations in vitro in Chinese Hamster Ovary cells.