5-[(2-hydroxyethyl)amino]-o-cresol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

secondary literature

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

not specified

GLP compliance:

yes

Type of assay:

other: L5178 mouse lymphoma cells (HPRT)

Test material

Test material information

Constituent 1

Reference substance name:

5-[(2-hydroxyethyl)amino]-o-cresol

EC Number:

259-583-7

EC Name:

5-[(2-hydroxyethyl)amino]-o-cresol

Cas Number:

55302-96-0

Molecular formula:

C9H13NO2

IUPAC Name:

5-[(2-hydroxyethyl)amino]-2-methylphenol

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0121442
- Purity: 99.8%
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL: no data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING: no data

FORM AS APPLIED IN THE TEST (if different from that of starting material)
Concentrations: 150 –1670 μg/ml (10 mM) without metabolic activation
150 –1670 μg/ml (10 mM) with metabolic activation
Cells: L5178Y mouse lymphoma cells (HPRT)
Replicates: 2 independent tests with and without S9 mix

Method

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

Liver S9 fraction from Aroclor 1254-induced rats was used as the exogenous metabolic activation system.

Test concentrations with justification for top dose:

150 –1670 μg/ml (10 mM) without metabolic activation
150 –1670 μg/ml (10 mM) with metabolic activation

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: no data
- Justification for choice of solvent/vehicle: no data

Details on test system and experimental conditions:

no detailed in the SCCS report

Results and discussion

Test results

Key result

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: secondary source results (SCCS opinion)

Applicant's summary and conclusion

Conclusions:

The test substance did not induce significant and / or reproducible increases in the mutant frequencies after the 3-hour treatment in the presence or absence of S9 mix. Under the experimental conditions used, Methyl-5-hydroxyethylamino-phenol (A31) was not mutagenic in the in vitro HPRT gene mutation test with L5178Y mouse lymphoma cells.

Executive summary:

Methyl-5-hydroxyethylamino-phenol has been investigated for induction of gene mutations at the HPRT-locus in L5178Y mouse lymphoma cells after exposure for 3 hours without and with metabolic activation. Liver S9 fraction from Aroclor 1254-induced rats was used as the exogenous metabolic activation system. Test concentrations were based on the level of toxicity.

Since the test substance was only moderately toxic in the preliminary test, the highest concentration was 10 mM (equivalent to 1670 μg/ml). Negative and positive controls were in accordance with the OECD guideline.

The highest concentration tested led to about 30% relative survival in the absence and in the presence of S9 mix. The test substance did not induce significant and / or reproducible increases in the mutant frequencies after the 3-hour treatment in the presence or absence of S9 mix. Under the experimental conditions used, Methyl-5-hydroxyethylamino-phenol (A31) was not mutagenic in the in vitro HPRT gene mutation test with L5178Y mouse lymphoma cells.