Methyl (S)-(-)-lactate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Methanol CAS N°: 67-56-1

Author:

Anonymous

Year:

2004

Bibliographic source:

UNEP Publications: SIDS Initial Assessment Report SIAM 19, Berlin, Germany

Report date:

2004

Reference 2

Reference Type:

other: unpublished data

Title:

Bericht zur Prüfung auf sensibilisierende Wirkung am Meerschweinchen-Maximierungstest (Magnusson und Kligman).

Author:

BASF AG

Year:

1979

Bibliographic source:

OECD SIDS. Methanol, UNEP Publication: SIDS Initial Assessment Report SIAM 19. Berlin Germany, 18-20 October 2004

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The study conducted was a modified Magnussen-Kligman test in guinea pigs.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

Methanol

EC Number:

200-659-6

EC Name:

Methanol

Cas Number:

67-56-1

Molecular formula:

CH4O

IUPAC Name:

methanol

Specific details on test material used for the study:

- Name of test material: methanol

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

water

Concentration / amount:

50%

Day(s)/duration:

7 days ( 1 week between each treatment)

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

50%

No. of animals per dose:

1st study: 10 test animals, 5 control animals
2nd study: two studies with 12 test animals, 5 controls

Details on study design:

Two studies were conducted using 10 test animals (1st study) and 24 test animals (2nd study) with each 5 control animals. During challenge in the first study, a formaldehyde solution (25 %) was applied in order to identify possible sensitisation effect that might be caused by metabolism-related transformation of methanol to formaldehyde.
The induction scheme was modified as follows (1 week between each treatment):
0.1 ml volume, 50 % test substance
- 1st intradermal induction (including 6 parallel injections with Freund´s Adjuvans solely, with methanol solely and both combined)
- 1st epidermal induction
- 2nd intradermal induction (including 4 parallel injections with methanol solely and combined with Freund´s Adjuvans)
- 2nd epidermal induction.

Challenge controls:

Control groups

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Remarks on result:

other:

Remarks:

see box "Any other information on results incl. tables".

Any other information on results incl. tables

In the first study, no contact sensitisation was observed, in the parallel test with formaldehyde, also a negative result was seen. In the second study using 24 female animals (two tests à 12 animals), 1/12 (test 1) and 2/12 (test 2) exhibited a slight skin response (score 1) after 24 and 48 h which can be interpreted as a weak sensitising potential. The intracutaneous induction produced necroses and some open ulcerations.

In summary, the low number of 3/24 animals with score 1 gives no evidence of a notable sensitisation potential of methanol.

 

                 

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

In the OECD SIDS report for methanol, a guinea pig maximization study is reported to be the key study for the assessment of a sensitizing potential of methanol. No evidence of a notable skin sensitization potential of methanol was derived based on the results.

Executive summary:

In the OECD SIDS report for methanol (2004), guinea pig maximization studies are reported to be the key studies for the assessment of a sensitizing potential of methanol. A first guinea pig maximization test gave no evidence of contact sensitisation in 10 female animals after induction and challenge with a 50 % aqueous methanol solution (0.1 mL). In a second guinea pig sensitization test using 24 female animals (two tests with 12 animals each), 1 of 12 (test 1) and 2 of 12 (test 2) animals exhibited a slight skin response (score 1) after 24 and 48 hours. In summary, the low number (3 of 34) animals with a score of 1 show no notable sensitisation potential of methanol.