Sodium 2-(2-dodecyloxyethoxy)ethyl sulphate

Endpoint summary

Description of key information

The substance sodium 2-(2-dodecyloxyethoxy) ethyl sulphate does not exhibit repeated dose toxicity by the oral ,inhalation and dermal route.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: oral

Remarks:

other: Reproduction

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Justification for type of information:

QSAR prediction: migrated from IUCLID 5.6

Qualifier:

according to guideline

Guideline:

other: estimated data

Principles of method if other than guideline:

Prediction is done using QSAR Toolbox version 3.1

GLP compliance:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

21 days

Frequency of treatment:

7 days/week

Dose descriptor:

LOEL

Effect level:

508 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: Increased organ weight, Hypertrophy

Critical effects observed:

not specified

The prediction was based on dataset comprised from the following descriptors: "NOEL calculated","study NOEL","study LOEL","effect LOEL"
Estimation method: Takes average value from the 5 nearest neighbours
Domain  logical expression:Result: In Domain

((((("a" or "b" or "c" or "d" or "e" or "f" or "g" )  and ("h" and ( not "i") )  )  and (("j" or "k" or "l" or "m" or "n" or "o" or "p" )  and ("q" and ( not "r") )  )  and (("s" or "t" or "u" or "v" or "w" or "x" or "y" )  and ("z" and ( not "aa") )  )  )  and "ab" )  and ("ac" and "ad" )  )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Anionic Surfactants AND Nonionic Surfactants by US-EPA New Chemical Categories

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Alkoxy AND Ether AND Sulfate by Organic functional groups

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Alkoxy AND Ether AND Overlapping groups AND Sulfate by Organic functional groups (nested)

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Aliphatic Carbon [CH] AND Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Hydroxy, sulfur attach [-OH] AND Miscellaneous sulfide (=S) or oxide (=O) AND Oxygen, aliphatic attach [-O-] AND Suflur {v+4} or {v+6} AND Sulfate, linear [-O-SO2-O-] AND Sulfinic acid [-S(=O)OH] AND Sulfite, linear [-OS(=O)O-] AND Sulfonic [SO2(-OH)-O] by Organic functional groups (US EPA)

Domain logical expression index: "e"

Referential boundary: The target chemical should be classified as Group 1 - Alkali Earth Li,Na,K,Rb,Cs,Fr AND Group 14 - Carbon C AND Group 16 - Oxygen O AND Group 16 - Sulfur S by Chemical elements

Domain logical expression index: "f"

Referential boundary: The target chemical should be classified as Dialkylether AND Ether AND Sulfuric acid derivative AND Sulfuric acid monoester by Organic functional groups, Norbert Haider (checkmol)

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as Aliphatic Carbon [CH] AND Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Miscellaneous sulfide (=S) or oxide (=O) AND Oxygen, aliphatic attach [-O-] AND Suflur {v+4} or {v+6} AND Sulfate, linear [-O-SO2-O-] AND Sulfite, linear [-OS(=O)O-] by Organic functional groups (US EPA)

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as No alert found by DNA binding by OASIS v.1.1

Domain logical expression index: "i"

Referential boundary: The target chemical should be classified as Michael addition OR Michael addition >> Quinone type compounds OR Michael addition >> Quinone type compounds >> Quinoneimine Derivatives OR Michael addition >> Quinone type compounds >> Quinones OR Radical OR Radical >> Free radical formation OR Radical >> Free radical formation >> Arenediazonium Salts OR Radical >> Generation of reactive oxygen species OR Radical >> Generation of reactive oxygen species >> Thiols OR Radical >> Radical mechanism by ROS formation OR Radical >> Radical mechanism by ROS formation >> Nitro Compounds OR Radical >> Radical mechanism by ROS formation >> Nitroso compounds OR Radical >> Radical mechanism by ROS formation >> Quinones OR Radical >> Radical mechanism by ROS formation >> Specific Imine and Thione Derivatives OR Radical >> ROS formation after GSH depletion OR Radical >> ROS formation after GSH depletion >> Aromatic and Heterocyclic Primary Amines OR Radical >> ROS formation after GSH depletion >> Quinoneimine Derivatives OR Schiff base fomers OR Schiff base fomers >> Direct acting Schiff base formers OR Schiff base fomers >> Direct acting Schiff base formers >> Specific Acetate Esters OR SN1 OR SN1 >> Carbenium ion formation OR SN1 >> Carbenium ion formation >> Nitroso compounds OR SN1 >> Carbenium ion formation >> Polycyclic Aromatic Hydrocarbons OR SN1 >> Carbenium ion formation >> Specific Acetate Esters OR SN1 >> Glutathione-induced nitrenium ion formation OR SN1 >> Glutathione-induced nitrenium ion formation >> Nitroso compounds OR SN1 >> Nitrenium and/or Carbenium ion formation OR SN1 >> Nitrenium and/or Carbenium ion formation >> Urea Derivatives OR SN1 >> Nitrenium ion formation OR SN1 >> Nitrenium ion formation >> Aromatic and Heterocyclic Primary Amines OR SN1 >> Nitrenium ion formation >> N-hydroxylamines OR SN1 >> Nitrenium ion formation >> Nitro Compounds OR SN1 >> Non-enzymatic nitroso radical and/or nirtosonium cation formation OR SN1 >> Non-enzymatic nitroso radical and/or nirtosonium cation formation >> Nitroso compounds OR SN1 >> Non-enzymatic nitroso radical and/or nirtosonium cation formation >> Urea Derivatives OR SN2 OR SN2 >> Acylating agents OR SN2 >> Acylating agents >> Specific Acetate Esters OR SN2 >> Carbenium Ion Formation OR SN2 >> Carbenium Ion Formation >> Arenediazonium Salts OR SN2 >> Diazonium ion formation OR SN2 >> Diazonium ion formation >> Specific Imine and Thione Derivatives OR SN2 >> P450-mediated epoxidation OR SN2 >> P450-mediated epoxidation >> Polycyclic Aromatic Hydrocarbons OR SN2 >> SN2 at sp3-carbon atom OR SN2 >> SN2 at sp3-carbon atom >> Specific Acetate Esters OR SN2 >> SN2 at sp3-carbon atom >> Sulfonates and Sulfates by DNA binding by OASIS v.1.1

Domain logical expression index: "j"

Referential boundary: The target chemical should be classified as Anionic Surfactants AND Nonionic Surfactants by US-EPA New Chemical Categories

Domain logical expression index: "k"

Referential boundary: The target chemical should be classified as Alkoxy AND Ether AND Sulfate by Organic functional groups

Domain logical expression index: "l"

Referential boundary: The target chemical should be classified as Alkoxy AND Ether AND Overlapping groups AND Sulfate by Organic functional groups (nested)

Domain logical expression index: "m"

Referential boundary: The target chemical should be classified as Aliphatic Carbon [CH] AND Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Hydroxy, sulfur attach [-OH] AND Miscellaneous sulfide (=S) or oxide (=O) AND Oxygen, aliphatic attach [-O-] AND Suflur {v+4} or {v+6} AND Sulfate, linear [-O-SO2-O-] AND Sulfinic acid [-S(=O)OH] AND Sulfite, linear [-OS(=O)O-] AND Sulfonic [SO2(-OH)-O] by Organic functional groups (US EPA)

Domain logical expression index: "n"

Referential boundary: The target chemical should be classified as Group 1 - Alkali Earth Li,Na,K,Rb,Cs,Fr AND Group 14 - Carbon C AND Group 16 - Oxygen O AND Group 16 - Sulfur S by Chemical elements

Domain logical expression index: "o"

Referential boundary: The target chemical should be classified as Dialkylether AND Ether AND Sulfuric acid derivative AND Sulfuric acid monoester by Organic functional groups, Norbert Haider (checkmol)

Domain logical expression index: "p"

Referential boundary: The target chemical should be classified as Aliphatic Carbon [CH] AND Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Miscellaneous sulfide (=S) or oxide (=O) AND Oxygen, aliphatic attach [-O-] AND Suflur {v+4} or {v+6} AND Sulfate, linear [-O-SO2-O-] AND Sulfite, linear [-OS(=O)O-] by Organic functional groups (US EPA)

Domain logical expression index: "q"

Referential boundary: The target chemical should be classified as Non binder, non cyclic structure by Estrogen Receptor Binding

Domain logical expression index: "r"

Referential boundary: The target chemical should be classified as Moderate binder, NH2 group OR Moderate binder, OH grooup OR Non binder, impaired OH or NH2 group OR Non binder, MW>500 OR Non binder, without OH or NH2 group OR Strong binder, NH2 group OR Strong binder, OH group by Estrogen Receptor Binding

Domain logical expression index: "s"

Referential boundary: The target chemical should be classified as Anionic Surfactants AND Nonionic Surfactants by US-EPA New Chemical Categories

Domain logical expression index: "t"

Referential boundary: The target chemical should be classified as Alkoxy AND Ether AND Sulfate by Organic functional groups

Domain logical expression index: "u"

Referential boundary: The target chemical should be classified as Alkoxy AND Ether AND Overlapping groups AND Sulfate by Organic functional groups (nested)

Domain logical expression index: "v"

Referential boundary: The target chemical should be classified as Aliphatic Carbon [CH] AND Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Hydroxy, sulfur attach [-OH] AND Miscellaneous sulfide (=S) or oxide (=O) AND Oxygen, aliphatic attach [-O-] AND Suflur {v+4} or {v+6} AND Sulfate, linear [-O-SO2-O-] AND Sulfinic acid [-S(=O)OH] AND Sulfite, linear [-OS(=O)O-] AND Sulfonic [SO2(-OH)-O] by Organic functional groups (US EPA)

Domain logical expression index: "w"

Referential boundary: The target chemical should be classified as Group 1 - Alkali Earth Li,Na,K,Rb,Cs,Fr AND Group 14 - Carbon C AND Group 16 - Oxygen O AND Group 16 - Sulfur S by Chemical elements

Domain logical expression index: "x"

Referential boundary: The target chemical should be classified as Dialkylether AND Ether AND Sulfuric acid derivative AND Sulfuric acid monoester by Organic functional groups, Norbert Haider (checkmol)

Domain logical expression index: "y"

Referential boundary: The target chemical should be classified as Aliphatic Carbon [CH] AND Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Miscellaneous sulfide (=S) or oxide (=O) AND Oxygen, aliphatic attach [-O-] AND Suflur {v+4} or {v+6} AND Sulfate, linear [-O-SO2-O-] AND Sulfite, linear [-OS(=O)O-] by Organic functional groups (US EPA)

Domain logical expression index: "z"

Referential boundary: The target chemical should be classified as No alert found by Protein binding by OASIS v1.1

Domain logical expression index: "aa"

Referential boundary: The target chemical should be classified as Acylation OR Acylation >> Direct acylation involving a leaving group OR Acylation >> Direct acylation involving a leaving group >> Carbamates OR Acylation >> Direct acylation involving a leaving group >> N-acylamides OR Acylation >> Direct acylation involving a leaving group >> N-acylated heteroaromatic amines OR Acylation >> Direct acylation involving a leaving group >> N-acylsulphonamides OR Acylation >> Ester aminolysis OR Acylation >> Ester aminolysis >> Amides OR Acylation >> Ester aminolysis >> Dithiocarbamates OR Acylation >> Ester aminolysis or thiolysis OR Acylation >> Ester aminolysis or thiolysis >> Activated alkyl or aryl esters OR Acylation >> Ester aminolysis or thiolysis >> Diarylesters OR Acylation >> Ring opening acylation OR Acylation >> Ring opening acylation >> Active cyclic agents OR Michael addition OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group >> alpha,beta-carbonyl compounds with polarized double bonds OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group >> Vinyl sulfonyl compounds OR Michael addition >> Michael type addition on vinyl pirydines and activated ethenylarenes OR Michael addition >> Michael type addition on vinyl pirydines and activated ethenylarenes >> Activated electrophilic ethenylarenes OR Michael addition >> Quinone type compounds OR Michael addition >> Quinone type compounds >> Naphtoquinone and naphtoquinone imines OR Michael addition >> Quinone type compounds >> Quinone (di)imines OR Michael addition >> Quinone type compounds >> Quinone methide imines OR Michael addition >> Quinone type compounds >> Quinone methides OR Nucleophilic addition OR Nucleophilic addition >> Addition to Carbon-hetero double/triple bond OR Nucleophilic addition >> Addition to Carbon-hetero double/triple bond >> Thiocyanates OR Nucleophilic addition >> Nucleophilic addition at polarized N-functional double bond OR Nucleophilic addition >> Nucleophilic addition at polarized N-functional double bond >> C-Nitroso compounds OR Schiff base formation OR Schiff base formation >> Nucleophilic cycloaddition to diketones OR Schiff base formation >> Nucleophilic cycloaddition to diketones >> Diketones OR Schiff base formation >> Pyrazolones and pyrazolidinones derivatives OR Schiff base formation >> Pyrazolones and pyrazolidinones derivatives >> Pyrazolones and pyrazolidinones OR Schiff base formation >> Schiff base formation with carbonyl compounds OR Schiff base formation >> Schiff base formation with carbonyl compounds >> Aldehydes OR SN1 OR SN1 >> Nucleophilic substitution (SN1) on alkyl (aryl) mercury cations OR SN1 >> Nucleophilic substitution (SN1) on alkyl (aryl) mercury cations >> Mercury compounds OR SN2 OR SN2 >> Interchange reaction with sulphur containing compounds OR SN2 >> Interchange reaction with sulphur containing compounds >> Thiols and disulfide compounds OR SN2 >> Nucleophilic substitution at sp3 Carbon atom OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Activated alkyl esters OR SN2 >> Nucleophilic substitution at sulfur atom OR SN2 >> Nucleophilic substitution at sulfur atom >> Thiosulfate compounds OR SN2 >> Ring opening SN2 reaction OR SN2 >> Ring opening SN2 reaction >> Isothiazolones derivatives OR SNAr OR SNAr >> Nucleophilic aromatic substitution on activated halogens OR SNAr >> Nucleophilic aromatic substitution on activated halogens >> Activated haloarenes by Protein binding by OASIS v1.1

Domain logical expression index: "ab"

Similarity boundary:Target: C(CCCCCCCCCCC)OCCOCCOS(=O)(=O)O{-}.[Na]{+}
Threshold=80%,
Dice(Atom centered fragments)

Domain logical expression index: "ac"

Parametric boundary:The target chemical should have a value of log Kow which is >= 0.369

Domain logical expression index: "ad"

Parametric boundary:The target chemical should have a value of log Kow which is <= 1.69

Conclusions:

The Low Observed Effect Level (LOEL) of sodium 2-(2-dodecyloxyethoxy)ethyl sulphate in Sprague-Dawley rats in 21 days study was observed at dose concentration of 508 mg/kg bw/day (nominal)

Executive summary:

The Low Observed Effect Level (LOEL) of sodium 2-(2-dodecyloxyethoxy)ethyl sulphate in Sprague-Dawley rats in 21 days study was observed at dose concentration of 508 mg/kg bw/day (nominal)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LOAEL

508 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Quality of whole database:

The data is K2 level as the data has been obtained from QSAR model considered by OECD.

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

chronic toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Toxicity of Sodium Lauryl Sulphate was assessed in Rabbits in a 90-day study

GLP compliance:

not specified

Limit test:

no

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Diet : ad libitum
- Water : ad libitum
- Acclimation period : 6 hrs

Type of coverage:

other: Intact and abraded skin

Vehicle:

water

Details on exposure:

PREPARATION OF DOSING SOLUTIONS:
20% solution of SLS in water was applied daily to the intact and abraded skin of rabbits

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

90 days

Frequency of treatment:

Dosage was applied daily, five days a week

Remarks:

Doses / Concentrations:
0, 6, 60 or 150 mg/kg/day
Basis:
nominal per unit area

No. of animals per sex per dose:

Control:
2 males, 1 female
6 mg/kg/day:
3 males, 3 females
60 mg/kg/day:
3 males, 3 females
150 mg/kg/day:
4 males, 2 females

Control animals:

yes, concurrent vehicle

Details on study design:

The dosage levels selected represented 0, 1, 10 and 25% of the acute dermal LD50 (rounded off at 600 mg. per kg.)

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: No Data

DETAILED CLINICAL OBSERVATIONS: No Data

BODY WEIGHT: No Data

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No Data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No Data

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No Data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No Data

OPHTHALMOSCOPIC EXAMINATION: No Data

HAEMATOLOGY: Yes
- total erythrocyte counts, Hematocrit, hemoglobin, total and differential leukocyte counts were conducted initially prior to start of dosage and at 21 and 90 days

CLINICAL CHEMISTRY: Yes
- blood glucose and urea nitrogen concentration were conducted initially prior to start of dosage and at 21 and 90 days

URINALYSIS: Yes
- urine analyses were conducted initially prior to start of dosage and at 21 and 90 days.

NEUROBEHAVIOURAL EXAMINATION: No Data

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
All the abraded rabbits and one male and one female each of the intact skin group were sacrificed at 21 days and the remainder of the intact animals at 90 days. Those that died and the survivors were autopsied and all major tissues fixed in 10% formalin.

HISTOPATHOLOGY: Yes
Nine tissues including thyroid, pancreas, heart, liver, kidneys, adrenals, skin, brain and bone marrow were processed, stained with hematoxylin and eosin and examined microscopically

Clinical signs:

effects observed, treatment-related

Mortality:

mortality observed, treatment-related

Body weight and weight changes:

effects observed, treatment-related

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Details on results:

Clinical signs and mortality :
Two rabbits at the 150 mg. per kg. level died, one on the 21st day and one on the 56th day of the test

Body weight and weight gain :
There is no significant differences in growth responses between the untreated controls and those sacrificed at 21 days. These latter rabbits generally tended to show maintenance or a slight loss of body weight. Those that continued on test for 90 days generally showed a slight weight gain.

Haematology :
No significant alterations in total erythrocytes, hemoglobin or Hematocrit values

Clinical chemistry :
Blood glucose and urea nitrogen values reveal no aberrant findings at either 21 or 90 days.

Gross pathology :
Gross examination at necropsy failed to indicate any significant dose-related alterations in tissue pathology. Only the two rabbits that died in the group receiving SLS at 150 mg. per kg. showed evidence of significant deleterious gross change. Necropsy observations in rabbit that died at 21 days revealed marked diarrhea and mucosal sloughing of the gastrointestinal tract. Death appeared to be unrelated to the test treatment. The animal that died after 56 days of test showed evidence of pulmonary congestion, the lungs appearing consolidated and hemorrhagic with moderate quantities of fluid in the pleural cavity.

Histopathology :
No significant systemic tissue changes observed

Dose descriptor:

LOAEL

Effect level:

150 other: mg/kg/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: Mortality, body weight, Hematology, Clinical chemistry, Gross pathology, histopathology

Dose descriptor:

NOAEL

Effect level:

60 other: mg/kg/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: Mortality, body weight, Hematology, Clinical chemistry, Gross pathology, histopathology

Critical effects observed:

not specified

Conclusions:

The Low Observed Adverse Effect Level (LOAEL) of Sodium Lauryl Sulphate in a 90-day study on rabbits was observed at a dose concentration of 150 mg/kg/day.

The No Observed Adverse Effect Level (NOAEL) of Sodium Lauryl Sulphate in the same study was observed at a dose concentration of 60 mg/kg/day.

Executive summary:

The purpose of this study was to evaluate the toxicity of Sodium Lauryl Sulphate by dermal application.20% solution of Sodium Lauryl Sulphatein water was applieddaily, for five days a week,for 90 daysto the intact and abraded skin of rabbits at a dose concentration of0, 6, 60 or 150 mg/kg/day.Animals were kept in stocks for six hours and allowed food and water ad libitum each day. They were removed from the stocks and returned to their cages at the end of six hours.

Mortality, body weight, hematology, clinical chemistry, gross pathology, and histopathology were analyzed.

Two rabbits died on day 21 and 56 at the highest dose. Slight weight gain was observed for those that continued on test for 90 days. No significant alterations in total erythrocytes, hemoglobin, hematocrit, blood glucose and urea nitrogen values. Gross examination at necropsy failed to indicate any significant dose-related alterations in tissue pathology. Hence the NOAEL and LOAEL was considered to be 60 and 150 mg/kg/day respectively.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

60 mg/kg bw/day

Study duration:

subacute

Species:

rabbit

Quality of whole database:

The data is K2 level as the data has been obtained from the experimental study from reliable journal of "J. soc. cos. CHEM.’.Based upon this available data it is expected that the test chemical Sodium lauryl sulphate does not exhibit repeated dose dermal toxicity to rabbit within the mentioned dose level.

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Repeated dose toxicity: oral

Based on the various studies available with Klimish rating 2 for the target as well as read across substances for CAS NO 3088-31-1, also from category based on organic functional group along with similar mechanistic approach and having structural similarities defined by QSAR toolbox. The results for target as well as analogues are summarized as follows

 

Sr. No	End point	Value	Species	Route	Effects	Remarks
1	LOEL	508mg/ kg bw/day	rat	Oral	Increased organ weight, Hypertrophy	Predicted data for target chemical
2	NOAEL   LOAEL	50 mg/Kg bw /d   250 mg/Kg bw /d	Rat	Oral	increased in serum urea concentration observed	Data from publication for CAS NO 151-21-3
3	NOAEL	50 mg/kg bw/d	Rat	Oral	No effects were observed based on evaluations of body weight, food and water intake, hematology, bloodchemistry,urine analysis and histopathology.	Data from publication for CAS: 13150-00-0

 

Based on the studies summarized in the above table it can be observed that NOAEL values is 50 mg/Kg bw/ d. whereas the lowest effect observed value (LOEL) values varies from 250 -508 mg/kg bw/d. The effects observed on these doses was listed as follows

·        Increased organ weight, Hypertrophy

·        increased in serum urea concentration observed

·        No effects were observed based on evaluations of body weight, food and water intake, hematology, bloodchemistry,urine analysis and histopathology.

Thus based on above values it can be concluded that substance CAS NO 3088-31-1 is expected to show the similar toxicological effect based on the effects observed on the other category members. Since no effective dose value (NOAEL) is 50 mg/Kg bw/d thus based on this value it can be concluded that substance CAS NO 3088-31-1 is considered to be not toxic to repeated dose via oral route for the above mentioned dose. Also there are no known evidence of adverse effect to Human of CAS NO 3088-31-1 as well as mechanistic trigger does not indicates any concern of CAS NO 3088-31-1 on toxicity to human.

 

Repeated dose toxicity: inhalation

The test substance has very low vapor pressure , so the potential for the generation of inhalable forms is low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore no acute inhalation test was performed.

Repeated dose toxicity: dermal

The purpose of this study was to evaluate the toxicity of Sodium Lauryl Sulphate by dermal application.20% solution of Sodium Lauryl Sulphatein water was applieddaily, for five days a week,for 90 daysto the intact and abraded skin of rabbits at dose concentration of0, 6, 60, 150 mg/kg/day.Animals were kept in stocks for six hours and allowed food and water ad libitum each day. They were removed from the stocks and returned to their cages at the end of six hours.

Mortality, body weight, Hematology, Clinical chemistry, Gross pathology, and histopathology were analyzed.

Two rabbits died on day 21 and 56 at highest dose. Slight weight gain was observed for those that continued on test for 90 days. No significant alterations in total erythrocytes, hemoglobin, Hematocrit, Blood glucose and urea nitrogen values. Gross examination at necropsy failed to indicate any significant dose-related alterations in tissue pathology. Hence the NOAEL and LOAEL was considered to be 60 and 150 mg/kg/day respectively.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The Low Observed Effect Level (LOEL) of sodium 2-(2-dodecyloxyethoxy)ethyl sulphate in Sprague-Dawley rats in 21 days study was observed at dose concentration of 508 mg/kg bw/day (nominal)

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
The test substance has very low vapor pressure , so the potential for the generation of inhalable forms is low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore no acute inhalation test was performed.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
The purpose of this study was to evaluate the toxicity of Sodium Lauryl Sulphate by dermal application.20% solution of Sodium Lauryl Sulphatein water was applieddaily, for five days a week,for 90 daysto the intact and abraded skin of rabbits at dose concentration of0, 6, 60, 150 mg/kg/day.Animals were kept in stocks for six hours and allowed food and water ad libitum each day. They were removed from the stocks and returned to their cages at the end of six hours.
Mortality, body weight, Hematology, Clinical chemistry, Gross pathology, and histopathology were analyzed.
Two rabbits died on day 21 and 56 at highest dose. Slight weight gain was observed for those that continued on test for 90 days. No significant alterations in total erythrocytes, hemoglobin, Hematocrit, Blood glucose and urea nitrogen values. Gross examination at necropsy failed to indicate any significant dose-related alterations in tissue pathology. Hence the NOAEL and LOAEL was considered to be 60 and 150 mg/kg/day respectively.

Justification for classification or non-classification

The substance sodium 2-(2-dodecyloxyethoxy) ethyl sulphate do not show repeated dose toxicity effect for oral,dermal and inhalation route and thus will not be considered for further classification.