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EC number: 253-452-8 | CAS number: 37294-49-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
An in vivo skin irritation test was
performed with an aqueous formulation with 20-37% Registered substance
on intact and abraded skin. In this study, no irritation or corrosion
was observed. It is of note that the test substance was tested in
formulation, thus the data can only be used as supplementary
information. Additionally, the absence of skin effects in an acute
dermal study and in a human patch study were considered in a weight of
evidence approach to fill this endpoint.
In a bovine corneal opacity and permeability (BCOP) test, performed
according to OECD guideline and GLP principles, disodium isodecyl
sulfosuccinate induced a mean IVIS of 38.1. An IVIS > 3 and ≤ 55 does
not allow conclusion on classification for eye irritancy according to UN
GHS. Furthermore, an in vivo eye irritancy test is available, in which
an aqueous formulation with 20-37% disodium isodecyl sulfosuccinate was
tested. The formulation was found not to be irritating to the eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1971
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Limited report with only basic information on test substance purity.
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substances Act (FHSA) procedures
- Principles of method if other than guideline:
- Six instead of three animals were tested.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.5mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- SCORING SYSTEM: Draize et al, J. Pharmacol. exptl. therap., 82:377, 1944
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: effect on intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed at 24 and 72 h
- Remarks on result:
- other: effect on intact skin
- Remarks:
- No observation reported at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed at 24 and 72 h
- Remarks on result:
- other: effect on intact skin
- Remarks:
- No observation reported at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed at 24 and 72 h
- Remarks on result:
- other: effect on intact skin
- Remarks:
- No observation reported at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24/72 h mean
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed at 24 and 72 h
- Remarks on result:
- other: effect on intact skin
- Remarks:
- No observation reported at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24/72 h mean
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: effect on intact skin
- Remarks:
- No observation reported at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24/72 h mean
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed at 24 and 72 h
- Remarks on result:
- other: effect on intact skin
- Remarks:
- No observation reported at 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: effect on intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed at 24 and 72 h
- Remarks on result:
- other: effect on intact skin
- Remarks:
- No observation reported at 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed at 24 and 72 h
- Remarks on result:
- other: effect on intact skin
- Remarks:
- No observation reported at 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed at 24 and 72 h
- Remarks on result:
- other: effect on intact skin
- Remarks:
- No observation reported at 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed at 24 and 72 h
- Remarks on result:
- other: effect on intact skin
- Remarks:
- No observation reported at 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed at 24 and 72 h
- Remarks on result:
- other: effect on intact skin
- Remarks:
- No observation reported at 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed at 24 and 72 h
- Remarks on result:
- other: effect on intact skin
- Remarks:
- No observation reported at 48 h
- Irritant / corrosive response data:
- The structure of the tissue at the site of contact was not destroyed or changed irreversibly.
- Other effects:
- No edema was noted on abraded skin. the erythema score (mean of 6 animals ) was 1 after 24 hours (3 rabbits with score 2) and 0.17 after 72 hours (1 animal with score 1).
- Conclusions:
- In an in vivo skin irritation test performed with 0.5mL of an aqueous formulation with appr. 50% disodium isodecyl sulfosuccinate on intact and abraded skin, no irritation or corrosion was observed.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 03 Oct 2005 - 11 Oct 2005
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Test substance was applied as received (aqueous formulation with appr. 20% test substance). The study can be used as supportive evidence: no corrosive or irritating effects were seen. As the test substance was tested in formulation, the test is not considered sufficient to cover this endpoint.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Clipped skin of three rabbits was exposed to 0.5 mL formulated test substance semi-occlusively for 4 hours. Skin effects were observed at 1, 24 and 72 hours postdose.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA, USA
- Age at study initiation: appr. 2 months
- Weight at study initiation:3.2-3.4 kg
- Housing: individual, in suspended cages
- Diet: PMI rabbit chow, daily portions
- Water: ad libitum
- Acclimation period: at least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature-controlled rooms
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 03 Oct 2005 To: 11 Oct 2005 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped (intact and abraded skin)
- Vehicle:
- other: aqueous formulation
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5*2.5 cm (left side)
- Type of wrap if used: surgical gauze, secured with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours
SCORING according to Draize et al (1944) - Irritation parameter:
- erythema score
- Remarks:
- (and eschar formation)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- (and eschar formation)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- (and eschar formation)
- Basis:
- animal #1
- Remarks:
- intact skin / abraded skin
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: The dermal effects on the abraded skin were identical to the effects on intact skin.
- Irritation parameter:
- erythema score
- Remarks:
- (and eschar formation)
- Basis:
- animal #2
- Remarks:
- intact skin / abraded skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The dermal effects on the abraded skin were identical to the effects on intact skin.
- Irritation parameter:
- erythema score
- Remarks:
- (and eschar formation)
- Basis:
- animal #3
- Remarks:
- intact skin / abraded skin
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: The dermal effects on the abraded skin were identical to the effects on intact skin.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- intact skin / abraded skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The dermal effects on the abraded skin were identical to the effects on intact skin.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- intact skin / abraded skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The dermal effects on the abraded skin were identical to the effects on intact skin.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- intact skin / abraded skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The dermal effects on the abraded skin were identical to the effects on intact skin.
- Irritant / corrosive response data:
- There was no erythema or edema noted at 3 minutes, 1 hour and 4 hours after dosing. Slight erythema was noted at 24 hours after patch removal in 2/3 rabbits and absent in the third rabbit. Erythema was absent at 48 and 72 hours. Edema was absent at any time.
- Other effects:
- No clinical signs were noted.
- Interpretation of results:
- other: data insufficient for classification purposes
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an in vivo skin irritation test performed with an aqueous formulation with 20-37% disodium isodecyl sulfosuccinate on intact and abraded skin, no irritation or corrosion was observed.
- Executive summary:
An in vivo skin irritation test was performed with an aqueous formulation with 20-37% disodium isodecyl sulfosuccinate. Clipped skin of 3 male rabbits was exposed semi-occlusively to 0.5 ml for 4 hours (both intact and abraded skin was tested). There was no erythema or edema noted at 3 minutes, 1 hour and 4 hours after dosing. Slight erythema was noted at 24 hours after patch removal in 2/3 rabbits and absent in the third rabbit. Erythema was absent at 48 and 72 hours. Edema was absent at any time.
Based on these results, it is concluded that an aqueous formulation with 20-37% disodium isodecyl sulfosuccinate is not irritant to the skin. It is of note that since the test substance was tested in formuation, the data cannot be used for classification purposes.
Referenceopen allclose all
The dermal effects on the abraded skin were identical to the effects on intact skin.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Oct 2014 - 21 Oct 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- Adopted July 26, 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- EAmended by EC No. 1152/2010 No. L142, 09 December 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: The Ocular Toxicity Working Group (OTWG) of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Interagency Centre for the Evaluation of Alternative Toxicological Methods (NICEATM), March 2006
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: In Vitro Techniques in Toxicology Database (INVITTOX) protocol 127. Bovine Opacity and Permeability (BCOP) Assay, 2006
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: approx. 750 µl of 10% (w/v) dilution in physiological saline per cornea
- The stock solution was treated with ultrasonic waves until the test substance had completely dissolved
NEGATIVE CONTROL
- Amount applied: 750 µl of physiological saline per cornea
POSITIVE CONTROL
Amount applied: 750 µl per cornea
Concentration: 10% (w/v) benzalkonium chloride in physiological saline
- Duration of treatment / exposure:
- 10 minutes
- Details on study design:
- TEST SITE
- Isolated bovine cornea
REMOVAL OF TEST SUBSTANCE
- Washing: yes (with MEM with phenol red (Eagle’s Minimum Essential Medium, Invitrogen Corporation) and thereafter with cMEM)
- Time after start of exposure: 10 minutes
SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by incubation for 120 ± 10 minutes in cMEM. Then, corneas were incubated in sodium-fluorescein solution for 90 ± 5 minutes (both incubations at 32 ± 1°C).
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader
DATA EVALUATION:
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces an IVIS > 55 is defined as a corrosive or severe irritan (UN GHS: category 1);
For a test substance that induces an IVIS >3 and ≥ 55, no prediction on irritant potency can be made (UN GHS: no prediction can be made) - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 10 minutes
- Value:
- >= 15.8 - <= 51.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean score 38.1
- Other effects / acceptance of results:
- The opacity value was 10 in all three corneas treated with disodium isodecyl sulfosuccinate and permeability values ranged from 0.406 to 2.785. The corneas were turbid with spots after the 10 minutes of treatment with disodium isodecyl sulfosuccinate. No pH effect of the test substance was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from 15.8 to 51.4 after 10 minutes of treatment with Disodium isodecyl sulfosuccinate.
- Interpretation of results:
- other: the outcome does not allow conclusion on classification
- Remarks:
- Criteria used for interpretation of results: other: UN GHS
- Conclusions:
- In a bovine corneal opacity and permeability (BCOP) test, performed according to OECD guideline and GLP principles, disodium isodecyl sulfosuccinate induced a mean IVIS of 38.1. Based on an IVIS > 3 and ≤ 55, no prediction on eye irritancy of the test substance can be made.
- Executive summary:
A bovine corneal opacity and permeability (BCOP) test was performed with disodium isodecyl sulfosuccinate according to OECD guideline and GLP principles. Reliable positive and negative controls were included. The corneas treated with disodium isodecyl sulfosuccinate were turbid with spots after the 10 minutes of treatment. Mean in vitro irritancy score was 38.1 after 10 minutes of treatment. The opacity value was 10 in all three corneas treated with disodium isodecyl sulfosuccinate and permeability values ranged from 0.406 to 2.785. based on an IVIS > 3 and ≤ 55, no conclusion on classification for eye irritancy can be drawn according to GHS UN.
Reference
The individual in vitro irritancy scores for the negative controls ranged from -0.4 to 0.7. The individual positive control in vitro irritancy scores ranged from 156 to 168 for benzalkonium chloride (mean IVIS = 161.6). The corneas treated with the positive control substance were turbid after the 10 minutes of treatment.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Effects on skin: irritating with limit concentration of 50% for non-irritation
The conclusion on the skin irritant properties of the test substance is drawn in a weight-of-evidence approach based on all available data based upon Registered substance. Two in vivo skin irritation tests are available performed with either formulation of 20-37% (Cerven, 2005) or 50% (Carpenter, 1971). Based on these results, it is concluded that aqueous formulations up to 50% of Registered substance are not irritant to the skin.
In a Guinea pig maximisation test, 0.5 mL of the Registered substance was applied semi-occlusively to 6cm2skin at concentrations of 5%, 10%, 20% and 40% for 24 hours (2 animals/ concentration). The exposure to 20% solution correlates to application of 0.1g to 6cm2. At this dose, no oedema was seen, but signs of superficial necrosis were seen. The test substance was held in contact to the skin for 24 hours, which is regarded as worst case. Application of 0.05g did not result in an effect on the skin (Latour, 2015).
Additionally, the absence of skin effects in an acute dermal study in rabbits (See also Section 7.2.3) and in a modified Draize-Shelanski repeat insult patch test (See Section 7.4), the substance did not result in skin effects (Kliggman, 1976).
Taken all data together, it is concluded that Registered subsstance is not expected to be corrosive to the skin, but from a conservative viewpoint the group classification as irritating Category 2 (H315) is concluded, wiht limit concentration of 50% for non-irritation.
Effects on eye: irritating with limit concentration of 50% for non-irritation
In a key bovine corneal opacity and permeability (BCOP) test, Registered substance induced a mean IVIS of 38.1. An IVIS > 3 and ≤ 55 does not allow conclusion on classification for eye irritancy, however the substance does not lead to eye damage (WIL Research Europe, 2014).
Two supporting in vivo skin irritation tests were performed, one with an aqueous formulation with 50% and the other with a 20-37% of Registered substance on intact and abraded skin (Carpenter, 1971; Cerven, 2005). These formulations were not irritating. In these studies, no irritation or corrosion was observed. Additionally, the absence of skin effects in an acute dermal study in rabbits (See also Section 7.2.3) and in a human patch study (see Section 7.4.1) were considered in a weight of evidence approach to fill this endpoint.
The Registered substance was concluded not to be corrosive to the eye, but from a conservative viewpoint the Registered substance is considered to be irritating for eye, with limit concentration of 50% for non-irritation.
Justification for classification or non-classification
Based on the available data, Registered substance is concluded to be non-corrosive and not irritating to the skin, however a conservative (group) classficition for irritation Category 2 (H315) is proposed according to CLP Regulation (EC) No. 1272/2008, with limit concentration of 50%.
Based on the available data, Registered substance is concluded not to induce eye damage, however from a conservative viewpoint, the substance is classified as irritating for eye Category 2 (H319) according to CLP Regulation (EC) No. 1272/2008, with limit concentration of 50%.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.