Sodium O-ethyl dithiocarbonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Sodium hydroxide is both reagents used in the manufacture of sodium O-ethyl dithiocarbonate . Therefore, sodium hydroxide need to be considered in the assessment of sodium O-ethyl dithiocarbonate

Data source

Reference

Reference Type:

publication

Title:

Identification of contact allergens: the mouse ear sensitization assay.

Author:

Descotes, J.

Year:

1988

Bibliographic source:

J Toxicol -Cut & Ocular Toxicol 7:263-272

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Mouse ear swelling test. Substance applied to mouse ear with adjuvant with measure of subsequent swelling used to indicate hypersensitivity.

GLP compliance:

not specified

Type of study:

mouse ear swelling test

Justification for non-LLNA method:

An ear swelling study was used to examine the skin sensitising potential of ethanol. Ethanol was applied twice on the right ear after an induction procedure involving two scapular subcutaneous injection of adjuvant and multiple topical ethanol applications to the abdomen over a period of 14 days.

Test material

Test material information

1

Reference substance name:

Sodium O-ethyl dithiocarbonate

EC Number:

205-440-9

EC Name:

Sodium O-ethyl dithiocarbonate

Cas Number:

140-90-9

Molecular formula:

C3H6OS2.Na

IUPAC Name:

sodium (ethoxymethanethioyl)sulfanide

Test material form:

solid: bulk

Details on test material:

SEX /sodium O-ethyl dithiocarbonate is produced by the reaction of an ethyl alcohol with sodium hydroxide to form alcoholate and subsequently adding carbon disulfide to form SEX/ sodium O-ethyl dithiocarbonate.
SEX /sodium O-ethyl dithiocarbonate contains Ethanol/ethyl alcohol (CAS number 64-17-5) and sodium hydroxide (CAS number 1310-73-2) which are an integral part of the substance.
Ethanol/ethyl alcohol (CAS number 64-17-5) and sodium hydroxide (CAS number 1310-73-2) are both reagents used in the manufacture of SEX /sodium O-ethyl dithiocarbonate. Therefore, Ethanol/ethyl alcohol (CAS number 64-17-5) and sodium hydroxide (CAS number 1310-73-2) need to be considered in the assessment of SEX /sodium O-ethyl dithiocarbonate.


CAS name: ethyl alcohol
EC / List name: Ethanol
IUPAC name: ethanol
EC / List no.: 200-578-6
CAS no.: 64-17-5

CAS name: sodium hydroxide
EC / List name: Sodium hydroxide
IUPAC name: sodium hydroxide
EC / List no.: 215-185-5
CAS no.: 1310-73-2

In vivo test system

Test animals

Species:

mouse

Strain:

Swiss

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: IFFA-CREDO, L'Arbresle, France
- Age at study initiation: 6 - 8 weeks
- Housing: polyethylene cages
- Food and water ad libitum
- Acclimation period: 7 days

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

neat

Challenge

Challenge 1

Route:

intradermal and epicutaneous

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

neat

No. of animals per dose:

23

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
Anaesthetised animals received subcutaneous injection of 0.05ml of ethanol and complete Freund' adjuvant (CFA) into scapular region plus topical application to shaved abdomen (amount not specified - referred to as day 0).

B. CHALLENGE EXPOSURE
- No. of exposures: 7
- Day(s) of challenge: days 3, 5, 7, 10, 12 and 14 and 27
- Topical application on the shaved abdomen (amount not specified) on days above and a 2nd subcutaneous injection of CFA (0.05ml) on day 7 only.

OTHER: Mice were allowed to rest between days 14-26. On day 26, the thickness of the ear was measured before another topical application of the test substance to both sides of the ear. Ear thickness was measured again on days 27 and 28 (24 and 48 hours later). Thickness measurements were carried out with a mobile-disk dial caliper with an accuracy of 0.01mm.

Positive control substance(s):

yes

Remarks:

Penicillin, paraphenylene diamine and nickel chloride

Results and discussion

In vivo (non-LLNA)

Results

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

Measurements of 94 untreated mice showed an ear thickness of 0.214 mm with a typical variation of 0.002 mm. 

Results on sensitisation and challenge with ethanol:

Sex	Number	Before	24 hour	48 hour
Male	9	26.94 +/-1.02	27.22 +/-1.58 (101.0%)	27.78 +/-1.86 (103.1%)
Female	10	24.30 +/-1.38	24.95 +/-1.44 (102.7%)	23.55 +/-1.46 (96.9%)

Known moderate and strong sensitizers applied as controls produced significant swelling in this study.

Induction and challenge with the three positive controls all produced statistically significant increases in ear thickness.

 

Applicant's summary and conclusion

Interpretation of results:

other: not sensitising

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Classification: not sensitizing.Ethanol/ Ethyl Alcohol is both reagents used in the manufacture of sodium O-ethyl dithiocarbonate . Therefore, Ethanol/ Ethyl Alcohol need to be considered in the assessment of Reaction mass of sodium O-ethyl dithiocarbonate

Executive summary:

An ear swelling study was used to examine the skin sensitising potential of ethanol. Ethanol was applied twice on the right ear after an induction procedure involving two scapular subcutaneous injection of adjuvant and multiple topical ethanol applications to the abdomen over a period of 14 days. The degree of contact hypersensitivity is deduced from easr swelling measured 24 and 48 hours after application. Ethanol was found not to cause any statistical increase in ear swelling, in contrast to 3 positive controls which all caused a statistically significant increase.