Registration Dossier

Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliable well documented study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Transplacental genetic and cytogenetic effects of alkylating agents in the mouse I: Induction of somatic coat color mutations
Author:
Braun R et al.
Year:
1984
Bibliographic source:
Terat Carcinog Mutagen 4:449-457
Reference Type:
secondary source
Title:
EU Risk Assessment Report Dimethyl Sulphate
Author:
European Chemicals Bureu
Year:
2002
Bibliographic source:
EU RAR, Volume 12, Luxembourg 2002

Materials and methods

Type of study / information:
Mouse spot test
Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: OECD 484
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

DMS did not induce RS frequency in both crosses.

Table 1: Frequency of RS, WMVS and MDS in offsring derived from the cross NMRI x DBA

Compound

Dose (mg/kg)

Treatment day

No. of females treated

No. of litters

No. of offspringa

Average litter sizea

Offspring with

P

RS (%)

WMVS (%)

MDS (%)

DMS

50

10.25

60

42

387 (201)

9.2 (4.7)

0 (0)

0 (0)

0 (0)

> 0.05

a: These columns refer to the total number of offspring while the number of non-agouti offspring is given in brackets.

Table 2: Frequency of RS, WMVS and MDS in offspring derived from the cross C57 x T-stock at day 10.25 of embryonal development

Compound

Dose (mg/kg)

No. of females treated

No. of litters

No. of offspring

Average litter size

Offspring with

P

RS (%)

WMVS (%)

MDS (%)

DMS

25

87

28

181

6.5

2 (1.10)

2 (1.10)

0 (0)

> 0.05

DMS did not induce mutations up to the highest concentration.

Applicant's summary and conclusion