Methyl pyruvate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: Secondary source ECHA disseminated Dossier for CAS 687-47-8

Adequacy of study:

supporting study

Study period:

June 26, 1995 - July 10, 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

secondary source

Title:

ECHA disseminated dossier for CAS 687-47-8

Author:

ECHA

Year:

2016

Bibliographic source:

Study 1995 cited in ECHA disseminated dossier for CAS 687-47-8; Status Dec. 2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

an amount of 0.5 ml of the test substance was distributed over a patch measuring 2.5 x 2.5 cm.

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Results and discussion

In vivo

Irritant / corrosive response data:

Skin effects were observed with grades 1-2 for erytema and edema for 72 hours (not observed after 7 days). However, the authors identified these findings to be on a very small skin area on the edge of the application site, most probably by pressure of the bandage on the test patch underneath. Therefore, the toxicological significance of these skin effects is considered dubious.

Any other information on results incl. tables

Readings	Animal	Erythema	Edema
24h	1	2	2
	2	2	2
	3	1	1
48h	1	2	2
	2	2	2
	3	0	0
72h	1	2	1
	2	2	1
	3	0	0
7d	1	0	0
	2	0	0
	3	0	0
Mean (24h-72h)	1	2,0	1,7
	2	2,0	1,7
	3	0,3	0,3
Mean (24h-72h)	all animals	1,4	1,2

Applicant's summary and conclusion

Conclusions:

Skin effects were observed with grades 1-2 for erytema and edema for 72 hours (not observed after 7 days) for ethyl-lactate under the chosen testing conditions. However, the authors identified these findings to be on a very small skin area on the edge of the application site, most probably by pressure of the bandage on the test patch underneath. Therefore, the toxicological significance of these skin effects is considered dubious. Based on the structural similarity concerning the alkyl residue (methyl- vs. ethyl group) between ethyl-lactate and methylpyruvate and their close metabolic relationship (bilateral biotransformation between pyruvate and lactate via the lactate dehydrogenase), these findings are considered relevant for methylpyruvate. Although the origin of the observed skin reactions (test substance or wrapping) is doubtful, the respective scores are below 2.3 an d no inflammatory reactions are observed at the end of the observation period. Therefore, these findings do not warrant a classification according to regulation (EU) 1272/2008. According to UN-GHS, the test substance is to be classified "skin irritant" (category 3) due to the uncertainty of the ethiology of the observed findings.

Executive summary:

.