Sodium O-ethyl dithiocarbonate

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

The eyes were held closed for one minute, observed immediately for reaction 1 hr and 4 hrs later and then daily for 9 days.

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Sodium ethyl xanthate: Acute Oral, Eye and Dermal Toxicity Report

Author:

Hazleton Laboratories

Year:

1951

Bibliographic source:

Virginia, USA, 1951.

Reference 2

Reference Type:

review article or handbook

Title:

Priority existing chemical Report No. 5

Author:

Dep. of Health and Ageing, Australian Government

Year:

1995

Bibliographic source:

National Industrial Chemicals Notification and Assessment Scheme

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method: other: The study was done in 1951 using Reaction mass of SEX as a 10% solution at pH 10.5 to 11 and as a fine powder. Two groups of three albino rabbits each were used in this study.
A 0.05 ml aliquot of 10% aqueous solution of Reaction mass of SEX was instilled into the conjunctival sacs of the left eyes of albino rabbits of one group. The eyes were held closed for one minute, observed immediately for reaction 1 hr and 4 hrs later and then daily for 9 days.

GLP compliance:

not specified

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

Test animals / tissue source

Species:

rabbit

Strain:

other: albino rabbits

Details on test animals or tissues and environmental conditions:

TEST ANIMALS: Rabbit
- Strain: albino rabbits
- Sex: Not reported
- Source: Not reported
- Age: Not reported
- Weight at study initiation: Not reported
- Number of animals: 6

Test system

Vehicle:

other: 10% aqueous solution and unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

-10% aqueous solution of sodium ethyl xanthate
-30 mg powder of sodium ethyl xanthate

Duration of treatment / exposure:

A 0.05 ml aliquot of 10% aqueous solution of Reaction mass of SEX was instilled into the conjunctival sacs of the left eyes of albino rabbits of one group. The eyes were held closed for one minute, observed immediately for reaction 1 hr and 4 hrs later and then daily for 9 days.
30 mg of Reaction mass of SEX powder was applied to the conjunctival sacs of the second group of rabbits.

Observation period (in vivo):

9 days

Number of animals or in vitro replicates:

6

Details on study design:

-A 0.05 ml aliquot of 10% aqueous solution of Reaction mass of SEX was instilled into the conjunctival sacs of the left eyes of albino rabbits of one group. The eyes were held closed for one minute, observed immediately for reaction 1 hr and 4 hrs later and then daily for 9 days.
-Approximately 30 mg of Reaction mass of SEX powder was applied to the conjunctival sacs of the second group of rabbits. All three animals showed immediate marked irritation, scrambling, excitement and evidence of pain. There was lacrimation in one animal and phonation in another. Moderate irritation and oedema of the lids was observed in all the animals at the end of 1 hr. The same observations were noted at 4 hrs with one animal showing exudate. Mild irritation was seen after 24 hrs and two rabbits appeared normal after three days. One rabbit showed slight irritation until day 5. There were no signs of opacity or necrosis. The symptoms seen in the animals could be due to the physical irritation caused by solid particles in the eye. The animals were sacrificed on day 9 when no gross pathology was observed at autopsy.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hrs

Reversibility:

fully reversible

Remarks:

4 days

Remarks on result:

other: Powder is a moderate irritant to rabbit eyes while the 10% aqueous solution is mildly irritating .The eye effects produced by the powder were reversible, persisting for 24 hrs in all the animals with the effects lasting for up to 4 days in one animal.

Irritant / corrosive response data:

DESCRIPTION OF LESIONS:
-Mild irritation was observed immediately after instillation of 10% aqueous solution of Reaction mass of SEX
There were no signs of oedema or necrosis. Autopsy on day 9 did not reveal any gross pathology.
 -Moderate irritation to rabbit eyes was evident after instillation of 30 mg of Reaction mass of SEX powder to the conjunctival sacs.
All three animals showed immediate marked irritation, scrambling, excitement and evidence of pain. There was lacrimation in one animal and phonation in another. Moderate irritation and oedema of the lids was observed in all the animals at the end of 1 hr. The same observations were noted at 4 hrs with one animal showing exudate. Mild irritation was seen after 24 hrs and two rabbits appeared normal after three days. One rabbit showed slight irritation until day 5. There were no signs of opacity or necrosis. The symptoms seen in the animals could be due to the physical irritation caused by solid particles in the eye.The animals were sacrificed on day 9 when no gross pathology was observed at autopsy.

REVERSIBILITY:
-Mild irritation was evident after instillation of 10% aqueous solution but the eyes appeared normal one hour later. One animal showed slight irritation at 4 hrs but was normal on the second day.
-Moderate irritation to rabbit eyes was evident after instillation of 30 mg of Reaction mass of SEX powder.The eye effects produced by the powder were reversible, persisting for 24 hrs in all the animals with the effects lasting for up to 4 days in one animal.

The results of this study indicate that the powder is a moderate irritant to rabbit eyes while the 10% aqueous solution of Reaction mass of SEX is mildly irritating. The irritant effects of the solution disappeared 1 hr after instillation. The eye effects produced by the powder were reversible, persisting for 24 hrs in all the animals with the effects lasting for up to 4 days in one animal.

Any other information on results incl. tables

DESCRIPTION OF LESIONS:

-Mild irritation was observed immediately after instillation of 10% aqueous solution of Reaction mass of SEX

There were no signs of oedema or necrosis. Autopsy on day 9 did not reveal any gross pathology.

 -Moderate irritation to rabbit eyes was evident after instillation of 30 mg of Reaction mass of SEX powder to the conjunctival sacs.

All three animals showed immediate marked irritation, scrambling, excitement and evidence of pain. There was lacrimation in one animal and phonation in another. Moderate irritation and oedema of the lids was observed in all the animals at the end of 1 hr. The same observations were noted at 4 hrs with one animal showing exudate. Mild irritation was seen after 24 hrs and two rabbits appeared normal after three days. One rabbit showed slight irritation until day 5. There were no signs of opacity or necrosis. The symptoms seen in the animals could be due to the physical irritation caused by solid particles in the eye.The animals were sacrificed on day 9 when no gross pathology was observed at autopsy.

REVERSIBILITY:

-Mild irritation was evident after instillation of 10% aqueous solution but the eyes appeared normal one hour later. One animal showed slight irritation at 4 hrs but was normal on the second day.

-Moderate irritation to rabbit eyes was evident after instillation of 30 mg of Reaction mass of SEX powder.The eye effects produced by the powder were reversible, persisting for 24 hrs in all the animals with the effects lasting for up to 4 days in one animal.

The results of this study indicate that the powder is a moderate irritant to rabbit eyes while the 10% aqueous solution of Reaction mass of SEX is mildly irritating. The irritant effects of the solution disappeared 1 hr after instillation. The eye effects produced by the powder were reversible, persisting for 24 hrs in all the animals with the effects lasting for up to 4 days in one animal.

 

Applicant's summary and conclusion

Interpretation of results:

other: moderately irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Based on the descriptions of the lesions it is considered that SEX is classifiable as an moderately irritant according to EU criteria
Classification: moderately irritating

Executive summary:

The results of this study indicate that the powder is a moderate irritant to rabbit eyes while the 10% aqueous solution of SEX is mildly irritating.The irritant effects of the solution disappeared 1 hr after instillation. The eye effects produced by the powder were reversible, persisting for 24 hrs in all the animals with the effects lasting for up to 4 days in one animal.