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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
Substance was administered by occlusive application to the shaved abdomen of the rabbits either as 1.0 ml/kg of a 10% aqueous solution or as 1 gm/kg of the 100% dry material in a paste formed with water. The animals were observed for 12 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
Justification for type of information:
Sodium O-ethyl dithiocarbonate (SEX) as the main constituent of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide

Data source

Referenceopen allclose all

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 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:
This study was conducted in 1951 and was repeated later in the same year. Exposure in both studies was for 18 hrs and was not according to the OECD Guidelines for acute dermal irritation (4 hrs) or for dermal toxicity (24 hrs). The initial study was performed to assess dermal irritation but deaths during the study led to further studies. Substance was administered by occlusive application to the shaved abdomen of the rabbits either as 1.0 ml/kg of a 10% aqueous solution or as 1 gm/kg of the 100% dry material in a paste formed with water. The animals were observed for 12 days.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
-Name of test material (as cited in study report):sodium ethyl xanthate

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: 10% aqueous solution and unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
Sodium ethyl xanthate was administered by occlusive application to the shaved abdomen of the rabbits either as 1.0 ml/kg of a 10% aqueous solution or as 1 gm/kg of the 100% dry material in a paste formed with water. The animals were observed for 12 days.
Observation period:
The animals were observed for 12 days.
Number of animals:
12
Details on study design:
This study was conducted in 1951 and was repeated later in the same year. Exposure in both studies was for 18 hrs and was not according to the OECD Guidelines for acute dermal irritation (4 hrs)or for dermal toxicity (24 hrs).The initial study was performed to assess dermal irritation but deaths during the study led to further studies. Substance was administered by occlusive application to the shaved abdomen of the rabbits either as 1.0 ml/kg of a 10% aqueous solution or as 1 gm/kg of the 100% dry material in a paste formed with water. The animals were observed for 12 days.

Results and discussion

In vivo

Results
Irritation parameter:
other: oedema and pigmentation of the skin.
Basis:
mean
Time point:
other: 24 hrs
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Application of 1 gm/kg ofsubstance in the form of a paste resulted in the death of ten out of twelve animals within 24 hrs. The surviving animals had moderate irritation with oedema and pigmentation of the skin.
Irritant / corrosive response data:
Application of 1 gm/kg of Reaction mass of SEX in the form of a paste resulted in the death of ten out of twelve animals within 24 hrs. The surviving animals developed irritant effects including oedema and pigmentation of the skin.
Clinical Observations :surviving animal had moderate irritation with oedema and pigmentation of the skin.
Other effects:
Moderate amount of peritoneal fluid, visceral organs were normal.
Haemorrhagic lungs and peritoneal and pleural fluid. Other changes were markedly cyanotic ears (2/5), haemorrhagic conditions (2/5) and evidence of diarrhoea (3/5).
The liver appeared darkand mottled and the kidneys showed spotty haemorrhages

Any other information on results incl. tables

The dermal irritation/toxicity study in rabbits indicates that Reaction mass of SEX powder

is a moderate irritant while the10% solution is non irritating to the skin.

Results of the dermal application studies are summarised in Table 4.

Table 4:

Effects of sodium ethyl xanthate following dermal application

Animals

Dose

Clinical Observations

Gross pathology

3 rabbits

1 ml/kg, as 10%

solution

 

No skin irritation.

No substance related

changes.

 

3 rabbits

1 gm/kg, as a paste

2/3 died; surviving animal had moderate irritation with oedema and pigmentation of the skin.

 

Moderate amount of

peritoneal fluid, visceral

organs were normal.

 

5 male

rabbits

 

1 gm/kg, as a paste

5/5 died following

overnight exposure; oedemaof the skin with

pigmentation.

 

Haemorrhagic lungs andperitoneal and pleural fluid.

Other changes were

markedly cyanotic ears

(2/5), haemorrhagic

conditions (2/5) and

evidence of diarrhoea (3/5).

 

1 male

rabbit

 

1 gm/kg, as a more

liquid paste than

above

 

Moderate oedema and

pigmentation of the skin.

 

No substance related

changes.

 

3 rabbits

1 gm/kg as a paste

All 3 animals died within24 hrs; retropulsion,salivation, loss of rightingreflex and haemorrhagicand oedematous areas of the

skin were noted.

 

The liver appeared dark

and mottled and the kidneysshowed spotty

haemorrhages.

 

 

 

Applicant's summary and conclusion

Interpretation of results:
other: moderately irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, application of 10% solution of Reaction mass of SEX (pH 10.5 to 11) for 18 hrs did not cause skin irritation in rabbits. Similar application of 1 gm/kg ofReaction mass of SEX in the form of a paste resulted in the death of ten out of twelve animals within 24 hrs. The surviving animals developed irritant effects including oedema and pigmentation of the skin. The sulphide odour noted during the study suggests that decomposition of sodium ethyl xanthate occurred. The results of the study (Hazleton Laboratories 1951) indicate that Reaction mass of SEX is a moderate irritant while the10% solution is non irritating to the skin.
Executive summary:

The results of the study (Hazleton Laboratories 1951) indicate that Reaction mass of SEX  is a moderate irritant while the10% solution is non irritating to the skin.