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EC number: 827-581-0 | CAS number: -
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Remarks:
- Read-across to SCI
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- yes
- Remarks:
- No ophthalmological observations were performed.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, coco, 2-sulfoethyl esters, sodium salts
- EC Number:
- 263-052-5
- EC Name:
- Fatty acids, coco, 2-sulfoethyl esters, sodium salts
- Cas Number:
- 61789-32-0
- Molecular formula:
- C10H20O5S.Na-C20H40O5S.Na
- IUPAC Name:
- Fatty acids, coco, 2-sulfoethyl esters, sodium salts
- Details on test material:
- - Name of test material: Sodium cocoyl isethionate (SCI)
- Analytical purity: 72.45%
- Lot/batch No.: 1247
- Stability under test conditions: Stable for the duration of the study
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River COBS CDR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Portage, MI, U.S.
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 176-200g
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: Clipped dorsal area, 32 cm2 for body weights below 350 g, 36 cm2 for body weights of 350 to 400 g and 40 cm2 for body weights of 400 g
- Type of wrap if used: Gauze
- Time intervals for shavings or clipplings:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.08 g a.i./kg (1.0% w/w), 0.91 g a.i./kg (14.0% w/w) and 2.07 g a.i./kg (36.0% w/w)
VEHICLE
- Millipore filtered water - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Test substance concentrations and stability of the test substance in aqueous dose suspensions were verified each week
- Duration of treatment / exposure:
- 6 hours /day
- Frequency of treatment:
- Daily for 6 hours/day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.08 g a.i./kg (1.0% w/w), 0.91 g a.i./kg (14.0% w/w) and 2.07 g a.i./kg (36.0% w/w)
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent vehicle
- Positive control:
- Not performed
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes. Twice daily
DETAILED CLINICAL OBSERVATIONS: Yes. Twice daily
DERMAL IRRITATION (if dermal study): Yes.Twice daily observations, once in the morning, once in the afternoon. Signs of local irritation were recorded using the Draize method of scoring. Skin reactions at the test site were recorded prior to treatment.
BODY WEIGHT: Yes. At start of test, weekly and prior to sacrifice
FOOD CONSUMPTION: Recorded weekly
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: Not recorded
HAEMATOLOGY: Yes. All animals at sacrifice (18-20 hour fast prior to sampling).
Parameters: Haemoglobin, mean corpuscular haemoglobin (MCH), mean corpuscular haemoglobin concentration (MCHC), mean corpuscular volume (MCV), packed cell volume (PCV), platelet count, prothrombin time, red blood cell (RBC) count, total and differential white blood cell (WBC) count.
CLINICAL CHEMISTRY: Yes. All animals at sacrifice (18-20 hour fast prior to sampling).
Parameters: A/G ratio, albumin, blood urea nitrogen, creatinine, 5¿-nucleotidase, globulin, glucose (fasted), lactate dehydrogenase, serum alanine aminotransferase, serum aspartate aminotransferase, serum calcium, serum chloride, serum phosphorus, serum potassium/sodium, sorbitol dehydrogenase, total bilirubin, total cholesterol, total serum protein and triglycerides.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS AND HISTOPATHOLOGY: Yes. Adrenal glands, aorta, brain, caecum, colon, duodenum, epididymis, oesophagus, eyes (2), femur, heart, ileum, jejunum, kidneys (2), liver, lungs, mammary gland, mesenteric lymph nodes, ovaries and fallopian tube, pancreas, peripheral nerve (sciatic), pituitary, prostate gland, rectum, salivary glands, seminal vesicles, skeletal muscles, skin and subcutis, spinal cord, spleen, sternum, stifle joint, stomach, testes, thymus, thyroid/parathyroid, tissue masses/abnormal tissue, trachea, urinary bladder, uterus and cervix.
- Other examinations:
- None
- Statistics:
- Dunn¿s Test, Jonckheere-Terpstra¿s Test, Dunnett¿s Test and Regression analysis were used as appropriate.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Very slight erythema (+1) was observed in two males during weeks 3 and 4. Dermal irritation in females was observed in each treatment group during week 1 of the study. Very slight erythema was observed in four females in the 1.0% (w/w) and 14.0% (w/w) treatment groups during the first week but no irritation was observed during the remainder of the study. Females in the 36.0% (w/w) group showed very slight and well-defined erythema (+2) which showed a significant difference from the control on days 4, 5, 6 and 7 of the study only Very slight oedema (+1) was also observed in females in this group but the difference was not significant.
Mortality: No treatment related effects. One male rat in the vehicle control group and one male rat in the 14.0% (w/w) group died during the study but these deaths were attributed to mechanical trauma due to struggling during the gauze wrapping procedure.
BODY WEIGHT AND WEIGHT GAIN
No significant difference between any group means during the test. Individual body weight data showed transient low weight gains and losses for males and females in all test groups, including the control.
FOOD CONSUMPTION
Males in the 14.0% (w/w) group showed a significant (p<0.05) increase in food consumption during weeks 1 and 4 of the test. There were no other significant differences in food consumption.
HAEMATOLOGY
Males showed a significant (p<0.05) decrease in average haemoglobin in the 36.0% (w/w) group. However, the effect was marginal and historical control data showed the haemoglobin concentration to be within the normal range for this species. All other results showed no treatment related effects.
CLINICAL CHEMISTRY
Average serum glucose concentration was significantly (p<0.05) lower in males in the 36.0% (w/w) group. Analysis showed that 3 of the ten rats showed values below that of the control. No indication of adverse treatment related effects were recorded for any other parameter tested. All other results showed no treatment related effects.
ORGAN WEIGHTS
A significant (p<0.05) increase in relative heart weight for males in the 36.0% (w/w) group was observed. However, historical control data showed the weights to be within the normal range. No other parameters were significantly different in males.
In females, the relative organ weight to final body weight showed a significant (p<0.05) increase in relative adrenal weight in the 36.0% (w/w) group. Again, historical control data showed the weights to be within the normal range. No other parameters were significantly different in females.
GROSS AND HISTOPATHOLOGY: Necropsy revealed red patchy areas on the lungs of rats occurring randomly throughout the control and test groups, with one rat showing pale lungs in the 1.0% (w/w) test group. None of these findings were considered to be treatment related.
Histopathology results showed no treatment related effects as all findings were considered to be incidental, except microscopic findings in the liver of one male in the 36.0% (w/w) treatment which showed fibrous trabeculae, increased Kupffer cell macrophages and lipofuscin pigment and one female in the vehicle control which showed coagulative necrosis of one liver lobe. These findings were determined to be due to mechanical trauma.
Excised skin sections showed slight microscopic differences in morphology between treated and untreated sites in each of the control and test groups. Skin from the treated sites showed a slight thickening of the epithelium and slightly increased cornification. The basal cell layer showed a slight increase in the mitotic rate in the treated skin sites compared to the untreated sites. These differences were attributed to the vehicle and semi-occlusive gauze dressing since there were no difference between the vehicle control and SCI treated groups. In addition, no inflammatory changes were observed.
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 2.07 other: g.a.i./kg
- Sex:
- male/female
- Basis for effect level:
- other: Local skin effects
- Dose descriptor:
- NOAEL
- Effect level:
- 2.07 other: g a.i./kg (36.0% w/w)
- Sex:
- male/female
- Basis for effect level:
- other: Systemic toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 0.91 other: g a.i./kg (14.0% w/w)
- Sex:
- male/female
- Basis for effect level:
- other: Local skin effects, based on transient irritation
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
There was no evidence of systemic toxicity in the treated animals during the test. Two animals died during the study, however, these deaths were attributed to mechanical trauma resulting from the semi-occlusive wrap procedure and not to test substance related effects. Observations revealed slight erythema and very slight oedma in 4/10 males at the highest test dose and in females in the highest test dose, respectively. Both findings were minimal and decreased towards the end of the study. Haematology and clinical chemistry results did not show treatment related effects during the test. Necropsy did not reveal any abnormal morphologic changes attributable to the test substance.
Clinical observation results of repeated dose toxicity (dermal) 28 days
Observation |
Vehicle control |
SCI, 0.08 g/kg |
SCI, 0.91 g/kg |
SCI, 2.07 g/kg |
||||
|
M |
F |
M |
F |
M |
F |
M |
F |
Number of animals examined |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
Clinical observations |
||||||||
Mortality |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Swollen snout/broken incisor |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Alopecia on forepaws |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
Chomodacryorrhea |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Scabs on skin |
1 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
Hematuria |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
Mean body weight gain during test |
52.8 ± 22.7 |
20.7 ± 14.3 |
48.3 ± 14.7 |
18.2 ± 13.5 |
64.8 ± 24.0 |
21.1 ± 7.9 |
36.8 ± 19.0 |
16.5 ± 9.4 |
Food consumption (g/rat/day) |
23.2 ± 1.9 |
16.5 ± 1.3 |
23.8 ± 1.3 |
17.0 ± 1.1 |
25.4 ± 2.6a |
16.9 ± 0.8 |
22.4 ± 1.2 |
17.4 ± 1.1 |
Clinical chemistry* |
||||||||
Glucose (mg/dL) |
118.7 ± 16.5 |
115.7 ± 15.0 |
114.9 ± 12.1 |
116.4 ± 10.0 |
118.9 ± 15.3 |
123.3 ± 8.0 |
101.7 ± 8.8d |
116.0 ± 21.7 |
Haematology* |
||||||||
Haemoglobin (g/dL) |
16.6 ± 0.7 |
15.7 ± 0.7 |
16.5 ± 0.8 |
15.8 ± 0.5 |
15.8 ± 0.6 |
15.6 ± 0.5 |
15.8 ± 0.8b |
15.6 ± 0.5 |
Haematocrit (%) |
44.8 ± 2.0 |
42.4 ± 1.8 |
44.4 ± 2.6 |
42.6 ± 1.9 |
41.6 ± 2.0c |
42.8 ± 2.3 |
42.5 ± 2.4 |
42.7 ± 1.6 |
Organ weights relative to body weight* |
||||||||
Adrenals |
0.024 ± 0.006 |
0.034 ±0.006 |
0.025 ± 0.005 |
0.039 ± 0.006 |
0.0024 ± 0.005 |
0.037 ± 0.004 |
0.025 ± 0.005 |
0.042 ± 0.008e |
Heart |
0.36 ± 0.02 |
0.40 ± 0.04 |
0.36 ± 0.03 |
0.41 ± 0.04 |
0.37 ± 0.03 |
0.39 ± 0.03 |
0.39 ± 0.03e |
0.42 ± 0.04 |
* Significantly different from the control group, p<0.05 (Dunnett¿s test).
bSignificantly different from the control group, p<0.05 (Dunnett¿s test) and significantly decreased trend with dose observed at p=0.004 (Regression Analysis).
cSignificantly different from the control group, p<0.01 (Dunnett¿s test) and significantly decreased trend with dose observed at p=0.014 (Regression Analysis).
dSignificantly different from the control group, p<0.05 (Dunn¿s test).
eSignificantly different from the control group, p<0.05 (Dunnett¿s test). Significantly increased trend with dose observed at p=0.005 for male relative heart weight and at p=0.018 for female relative adrenal weight (Regression Analysis).
* Only data with significant differences shown.
Dermal irritancy results of repeated dose toxicity (dermal) 28 days ¿ male rats
Erythema |
Oedema |
|||||||
|
0 |
+1 |
+2 |
+3 |
0 |
+1 |
+2 |
+3 |
Week 1 |
||||||||
Vehicle control |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.08 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.91 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 2.07 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
Week 2 |
||||||||
Vehicle control |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.08 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.91 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 2.07 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
Week 3 |
||||||||
Vehicle control |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.08 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.91 g/kg |
9/9 |
- |
- |
- |
9/9 |
- |
- |
- |
SCI, 2.07 g/kg |
8/10 |
2/10 |
- |
- |
10/10 |
- |
- |
- |
Week 4 |
||||||||
Vehicle control |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.08 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.91 g/kg |
9/9 |
- |
- |
- |
9/9 |
- |
- |
- |
SCI, 2.07 g/kg |
8/10 |
2/10 |
- |
- |
10/10 |
- |
- |
- |
Dermal irritancy results of repeated dose toxicity (dermal) 28 days ¿ female rats
|
Erythema |
Oedema |
||||||
|
0 |
+1 |
+2 |
+3 |
0 |
+1 |
+2 |
+3 |
Week 1 |
||||||||
Vehicle control |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.08 g/kg |
6/10 |
4/10 |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.91 g/kg |
6/10 |
4/10 |
- |
- |
10/10 |
- |
- |
- |
SCI, 2.07 g/kg |
3/10 |
2/10 |
5/10* |
- |
5/10 |
5/10 |
- |
- |
Week 2 |
||||||||
Vehicle control |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.08 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.91 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 2.07 g/kg |
5/10 |
3/10 |
2/10 |
- |
7/10 |
3/10 |
- |
- |
Week 3 |
||||||||
Vehicle control |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.08 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.91 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 2.07 g/kg |
6/10 |
2/10 |
2/10 |
- |
9/10 |
1/10 |
- |
- |
Week 4 |
||||||||
Vehicle control |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.08 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 0.91 g/kg |
10/10 |
- |
- |
- |
10/10 |
- |
- |
- |
SCI, 2.07 g/kg |
6/10 |
4/10 |
- |
- |
10/10 |
- |
- |
- |
* Significantly different from the control group, at p<0.05 on days 4, 5, 6 and 7 (Dunnett¿s test).
Significantly increased trend with dose observed (Jonckheere-Terpstra¿s test).
Applicant's summary and conclusion
- Conclusions:
- There was no evidence of systemic toxicity in the treated animals during the study up to the highest dose of 2.07 g/kg/day. Observations revealed very slight erythema in a few males at the highest dose and slight erythema and oedema in females at the highest dose. Both findings decreased in incidence and severity towards the end of the study.
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