N-methylformamide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

publication

Title:

Intralaboratory validation of alternative endpoints in the murine local lymph node assay for the identification of contact allergic potential: primary ear skin irritation and ear-draining lymph node hyperplasia induced by topical chemicals.

Author:

Ulrich, P. et al.

Year:

2001

Bibliographic source:

Arch. Toxicol. 74, 733-744, 2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Principles of method if other than guideline:

Method: other: according to Ulrich, P. et al.: Toxicology 125, 149-168

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

N,N-dimethylformamide, no further data

In vivo test system

Test animals

Species:

mouse

Strain:

Balb/c

Sex:

female

Details on test animals and environmental conditions:

6-8 weeks old

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Remarks:

DMF was a vehicle for other chemicals

No. of animals per dose:

6

Details on study design:

ANIMAL ASSIGNMENT AND TREATMENT
Name of test method: two.tired murine local lymph node assay

Results and discussion

In vivo (LLNA)

Results

Parameter:

SI

Remarks on result:

other: First experiment: slight ear-draining lymph node activation as expressed by increased weights and cell counts. However, this observation was not reproducible in a second experiment.

Any other information on results incl. tables

RS-Freetext:
Topical treatment of mice with the vehicle
N,N-dimethylformamide led to slight ear-draining lymph node
activation as expressed by increased weights and cell counts
in comparison to the untreated animals.
However, this observation was not reproducible in a second
experiment (i.e. when DMF was tested as vehicle for eugenol
and as vehicle alone in comparison to the respective
untreated control group).

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Topical treatment of mice with the vehicle N,N-dimethylformamide led to slight ear-draining lymphnode activation as expressed by increased weights and cell counts in comparison to the untreated animals. However, this observation was not reproducible in a second experiment

Executive summary:

N,N-dimethylformamide was used as a vehicle in the present
investigation.
The publication describes the validation of a two-tiered
murine local lymph node assay.
Groups of 6 female BALB/C strain mice (6-8 weeks old) were
used. During tier I a wide range of concentrations of test
chemical solutions or vehicle (volume: 25 µl) were applied
on three consecutive days to the dorsum of both ears. Mice
were killed 24 hours after the last application to determine
ear and local lymph node weights and lymph node cell counts.
Ear weights were determined to correlate chemical induced
skin irritation with the ear-draining lymph node activation
potential.
For comparison of the induction and challenge responses,
mice were treated on the shaved back with 50 µl of test
chemical or vehicle alone on three consecutive days
(induction phase treatment). Then mice were challenged 12
days after the final induction phase exposure with 25 µl of
test chemical or vehicel on the dorsum of both ears for a
further 3 days (challenge phase treatment). Lymph nodes were
excised 24 hours after the final challenge phase treatment.
A tier II LLNA protocol was used to finally differentiate
between true irritants and contact allergens.

To investigate the impact of different vehicles on the
primary response induced by two contact allergens, i.e
dinitrochlorobenzene (DNCB) at 0.5% and by eugenol at 35%,
DAE433, DMSO, DMF and acetone /oil olive (AOO) were used.
Both contact allergens were compared either to the untreated
control (aqua bidest) or to the corresponding vehicle
control.

RM-Freetext:
non-BASF study

RM-Freetext:
relevant for MSDS