Registration Dossier

Administrative data

Description of key information

-The acute eye irritation study indicates that S-allyl O-pentyl dithiocarbonate (the result was read across from sodium ethyl xanthate) as a powder caused mild to moderate irritation, while it is not an irritant in the diluted form (10% solution).

 

 -The results indicate that S-allyl O-pentyl dithiocarbonate (the result was read across from sodium ethyl xanthate) is a moderate irritant to the skin while the 10% solution is non irritating to the skin.

 

 -The results indicate that S-allyl O-pentyl dithiocarbonate (the result was read across from potassium amyl xanthate) has an adverse effect at concentration of 252 mg/m3 on the central nervous system and liver in mice, the liver and kidneys in rats and the liver in dogs. There were no treatment-related changes in the haematological or urinalysis values in any of the animals.

No signs of irritation of respiratory tract and Nasal effects were observe

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
other: published data
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
The S-allyl O-pentyl dithiocarbonate (CAS No. 2956-12-9), the subject of this dossier) is expected to exhibit very similar toxicity to Sodium ethyl xanthate (CAS No. 140-90-9)), which is also xanthate compound. Comparable metabolism would occur.
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. 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.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
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. 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.
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 of sodium ethyl xanthate 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 sodium ethyl xanthate 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

The dermal irritation/toxicity study in rabbits indicates that sodium ethyl xanthate 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.

 

 

 

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 sodium ethyl xanthate (pH 10.5 to 11) for 18 hrs did not cause skin irritation in rabbits. Similar application of 1 gm/kg of sodium ethyl xanthate 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 this study indicate that S-allyl O-pentyl dithiocarbonate (CAS No. 2956-12-9) (the result was read across from sodium ethyl xanthate) is a moderate irritant while the10% solution is non irritating to the skin.
Executive summary:

The results of this study indicate that  S-allyl O-pentyl dithiocarbonate (CAS No. 2956-12-9) (the result was read across from sodium ethyl xanthate) is a moderate irritant while the10% solution is non irritating to the skin.

Endpoint:
skin irritation / corrosion, other
Remarks:
Five albino rabbits were treated with 0.01 ml of primary amyl alcohol for a 24-hour period. The dosage was applied to the clipped, intact skin and left uncovered.
Type of information:
other: published data
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:
Pentan-1-ol/Amyl alcohol is both reagents used in the manufacture of S-allyl O-pentyl dithiocarbonate. Therefore, pentan-1-ol/Amyl alcohol need to be considered in the assessment of S-allyl O-pentyl dithiocarbonate.
Qualifier:
no guideline available
Principles of method if other than guideline:
Five albino rabbits were treated with 0.01 ml of primary amyl alcohol for a 24-hour period. The dosage was applied to the clipped, intact skin and left uncovered. Skin reactions were scored by the Draize method at the end of the 24-hour exposure interval.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 2.7 kg
- Diet (e.g. ad libitum): muemmel z (ssniff / Soest)
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 - 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): ca. 40
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
other: open at 0.01 ml for 24 hours and occluded at 0.5 ml for 4 hours
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
4-hour at 0.5 ml and 24-hour at 0.01 ml
Duration of treatment / exposure:
24 hour(s)
Observation period:
Unspecified in report but up to 14 days in guidelines.
Number of animals:
4 at 0.5 ml on occluded skin for 4 hours and 5 at 0.01 ml on unoccluded skin for 24 hours.
Details on study design:
Five albino rabbits were treated with 0.01 ml of primary amyl alcohol for a 24-hour period. The dosage was applied to the clipped, intact skin and left uncovered. Skin reactions were scored by the Draize method at the end of the 24-hour exposure interval.
Irritation parameter:
other: No scores available
Remarks on result:
other: 2 of 4 rabbits showed necrosis at the application site after occluded exposure for 4 hrs.
Irritant / corrosive response data:
2 of 4 rabbits had necrosis at the application site when 0.5 ml of test material was applied to occluded skin for 4 hours.
There was no irritation observed in rabbits following application of 0.01 ml test material applied to intact, uncovered skin for 24 hours.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Administration of 0.01 ml of test material to intact skin for 24 hours was not irritating..
Administration of 0.5 ml of test material to occluded skin for 4 hours resulted in necrosis in 2 of 4 rabbits.
Amyl Alcohol ( 1-pentyl alcohol) is both reagents used in the manufacture, as well as decomposition products of xanthates. Therefore, the health effects of Amyl Alcohol ( 1-pentyl alcohol) need to be considered in the assessment of potassium amyl xanthate.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
other: published data
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
The S-allyl O-pentyl dithiocarbonate (CAS No. 2956-12-9), the subject of this dossier) is expected to exhibit very similar toxicity to Sodium ethyl xanthate (CAS No. 140-90-9)), which is also xanthate compound. Comparable metabolism would occur.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: other: The study was done in 1951 using sodium ethyl xanthate 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 sodium ethyl xanthate 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
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

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 sodium ethyl xanthate 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 sodium ethyl xanthate 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 sodium ethyl xanthate 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 sodium ethyl xanthate 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.
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 sodium ethyl xanthate
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 sodium ethyl xanthate 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 sodium ethyl xanthate 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 sodium ethyl xanthate 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.

DESCRIPTION OF LESIONS:

-Mild irritation was observed immediately after instillation of 10% aqueous solution of sodium ethyl xanthate

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 sodium ethyl xanthate 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 sodium ethyl xanthate 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 sodium ethyl xanthate 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.

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 S-allyl O-pentyl dithiocarbonate ( (the result was read across from sodium ethyl xanthate) is classifiable as an moderately irritant according to EU criteria
The S-allyl O-pentyl dithiocarbonate (CAS No. 2956-12-9), the subject of this dossier) is expected to exhibit very similar toxicity to Sodium ethyl xanthate (CAS No. 140-90-9)), which is also xanthate compound. Comparable metabolism would occur.
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 S-allyl O-pentyl dithiocarbonate (the result was read across from sodium ethyl xanthate) 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.

Endpoint:
eye irritation: in vivo
Type of information:
other: published data
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:
Dithiocarbamates are related compounds to xanthates and xanthate esters. This is organosulfur compound is obtained by treating carbon disulfide with amine in the presence of sodium or potassium hydroxide: They arise from the reaction of the amine with CS2
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: A. Smith, England
- Age at study initiation: ca. 12 weeks
- Weight at study initiation: 2.6 kg
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
n.a.
Observation period (in vivo):
24 h
Number of animals or in vitro replicates:
1
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h
Score:
3
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 h
Score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h
Score:
3
Reversibility:
not reversible
Remarks on result:
other: Necrosis and partial destruction of nictitating membrane.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h
Score:
4
Reversibility:
not reversible
Other effects:
Due to the severity of the response only one animal was exposed to the test substance and the study was terminated on humane grounds 24 h after instillation.
Interpretation of results:
other: irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Instillation of 0.1 ml of ziram into rabbit eyes produced severe ocular irritation.
Dithiocarbamates are related compounds to xanthates and xanthate esters. This is organosulfur compound is obtained by treating carbon disulfide with amine in the presence of sodium or potassium hydroxide: They arise from the reaction of the amine with CS2
Endpoint:
eye irritation: in vivo
Type of information:
other: published data
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:
Pentan-1-ol/Amyl alcohol is both reagents used in the manufacture of S-allyl O-pentyl dithiocarbonate. Therefore, pentan-1-ol/Amyl alcohol need to be considered in the assessment of S-allyl O-pentyl dithiocarbonate.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period 14 days instead of 21 days as stated in OECD TG
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): no data
Duration of treatment / exposure:
one application
Observation period (in vivo):
14 d
The eyes were examined at 1, 24, 48, 72, and 96 hr.
Number of animals or in vitro replicates:
no data
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
Draize scoring system acc. to in the Journal officièl de la République Française (24.10.84)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 96 hr
Score:
28
Max. score:
100
Reversibility:
not reversible
Irritant / corrosive response data:
 Based on the test results, the substance was considered to be moderately irritating to the rabbit eye. The observed eye reactions were not completely reversible within 14 days of observation.

 Based on the test results, the substance was considered to be moderately irritating to the rabbit eye. The observed eye reactions were not completely reversible within 14 days of observation.

Interpretation of results:
other: moderately irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the test results, the substance was considered to be moderately irritating to the rabbit eye. The observed eye reactions were not completely reversible within 14 days of observation.
Pentan-1-ol/Amyl alcohol is both reagents used in the manufacture of S-allyl O-pentyl dithiocarbonate. Therefore, pentan-1-ol/Amyl alcohol need to be considered in the assessment of S-allyl O-pentyl dithiocarbonate.
Endpoint:
eye irritation, other
Remarks:
A volume of 0.05 ml was instilled directly into the rabbit eye. The left eye served as the control. Eye irritation was recorded in a 10-grade series
Type of information:
other: published data
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:
Pentan-1-ol/Amyl alcohol is both reagents used in the manufacture of S-allyl O-pentyl dithiocarbonate. Therefore, pentan-1-ol/Amyl alcohol need to be considered in the assessment of S-allyl O-pentyl dithiocarbonate.
Qualifier:
no guideline available
Principles of method if other than guideline:
A volume of 0.05 ml was instilled directly into the rabbit eye. The left eye served as the control. Eye irritation was recorded in a 10-grade series (Grade 1 negligible injury, Grade 10 very severe).
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Age at study initiation: young adult animals
- Weight at study initiation: 2.91 kg (male), 2.85 kg female)
- Diet (e.g. ad libitum): Ssniff
- Water: ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
other: left eye of the same animal treated with 0.05 ml NaCl solution
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
one application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed

SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system:
Cornea
(A) Opacity-degree of density (area most dense taken for reading)
0 = No opacity
1 = Scattered or diffuse area, details of iris clearly visible
2 = Easily discernible translucent areas, details of iris slightly obscured
3 = Opalescent areas, no details of iris visible, size of pupil barely discernible
4 = Opaque, iris invisible

Iris
(A) Values
0 = Normal
1 = Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination af any thereof) iris still reacting to light (sluggish reactions is positive)
2 = No reaction to light, hemorrhage, gross destruction (any or all of these)

(3) Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
0 = Vessels normal
1 = Vessels definitely injected above normal
2 = More diffuse, deeper crimson red, individual vessels not easily discernible
3 = Diffuse beefy red

(B) Chemesis
0 = No swelling
1 = Any swelling above normal (includes nictitatinq membrane)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids about half closed to completely closed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.8
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 hour
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Other effects:
Ulceration, iritis and bleeding were observed in the treated eyes until the end of the observation period (at least iritis and bleeding in one animal).

  Animal 1: female, 2.85 kg

Animal 2: male, 2.91 kg

Results:

Readings

Animal

Corneal opacity

Iris

conjunctiva

 

Erythema

Chemosis

Additional findings

24 h

1

2

0

2

2

sc

2

2

1

2

2

 

48 h

1

3

1

1

2

s

2

3

1

1

1

 

72 h

1

3

1

2

2

s, sc, b

2

3

1

1

0

b

6 d

1

3

2

1

2

s, b, ce

2

3

2

1

0

b, sc

8 d

1

3

2

2

2

s, sc, ce

2

3

2

1

0

 

Mean 24 - 72 h

1

2.7

0.7

1.7

2.0

sc

2

2.7

1.0

1.3

1.0

 

Mean

 

2.7

0.8

1.5

1.5

 

sc: scar

s: sanies

b: blood

ce: crusty eyelid

 

Interpretation of results:
other: irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Classification: irritating.
Pentan-1-ol/Amyl alcohol is both reagents used in the manufacture of S-allyl O-pentyl dithiocarbonate. Therefore, pentan-1-ol/Amyl alcohol need to be considered in the assessment of S-allyl O-pentyl dithiocarbonate.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

Based on the hazard assessment of S-allyl O-pentyl dithiocarbonate in section 2.1 and 2.2. in IUCLID 6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:

 

Directive

67/548

Skin Corrosivity C

R35 Causes severe burns

R34 Causes burns

Skin Irritation Xi

R38 Irritating to skin

R43 May cause sensitization by skin contact

Eye Irritation (Ocular Lesions) Xi

R36 Irritating to eyes

R37 irritating to respiratory system

R41 Risk of serious damage to eyes

R36/37/38 Irritating to eyes, respiratory system and skin.

R36/38 Irritating to eyes and skin.

CLP

Skin Corrosivity

H314 Skin Corr 1A Causes severe skin burns and eye damage

H314 Skin Corr 1B Causes severe skin burns and eye damage

Skin Irritation

H315 Skin Irrit. 2 Causes skin irritation

H317 Skin Sens. 1 May cause an allergic skin reaction

Eye Irritation (Ocular Lesions) Xi

H319 Eye Irrit. 2 Causes serious eye irritation

H318 Eye Dam. 1 Causes serious eye damage

H335 STOT SE 3 May cause respiratory irritation 

It is concluded that the substanceS-allyl O-pentyl dithiocarbonatemeet the criteria to be classified for human health hazards for Dermal-local effect :

R36/38 Irritating to eyes and skin.

H315 Skin Irrit. 2 Causes skin irritation,

H319 Eye Irrit. 2 Causes serious eye irritation,