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Registration Dossier
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EC number: 226-195-4 | CAS number: 5324-84-5
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
Endpoint waived due to existence of study equivalent/similar to OECD 414; Palmer et al. (1974)
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because a pre-natal developmental toxicity study is available
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
A study equivalent/similar to OECD 414 (Prenatal Developmental Toxicity Study; Palmer et al. 1974) was performed on a substance utilised in this dossier for Read-Across purposes (sodium dodecyl sulphate), therefore negating the need to commisssion an additional toxicity to reproduction study. As per Regulation (EC) 1907/2006, Annex VII, Part 8.7.1, Column 2 - the study/ies do(es) not generally need to be conducted if:
a pre-natal developmental toxicity study (Annex IX, 8.7.2: Pre-natal developmental toxicity study, one species, most appropriate route of administration, having regard to the likely route of human exposure - B.31 of the Commission Regulation on test methods as specified in Article 13(3) or OECD 414) is available.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
A study equivalent/similar to OECD 414 (Prenatal Developmental Toxicity Study; Palmer et al. 1974) was performed on a substance utilised in this dossier for Read-Across purposes (alcohol sulphate), therefore negating the need to commission an additional toxicity to reproduction study. As per Regulation (EC) 1907/2006, Annex VII, Part 8.7.1, Column 2 - the study/ies do(es) not generally need to be conducted if:
a pre-natal developmental toxicity study (Annex IX, 8.7.2: Pre-natal developmental toxicity study, one species, most appropriate route of administration, having regard to the likely route of human exposure - B.31 of the Commission Regulation on test methods as specified in Article 13(3) or OECD 414) is available.
Effects on developmental toxicity
Description of key information
NOAEL for maternal toxicity: 300 mg/kg bw/day; NOAEL for developmental toxicity > 600 mg/kg bw/day; equivalent/similar to OECD 414; Palmer et al, 1974.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- 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:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH - Refer to Section 13.2 for read-across justification document
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: East Anglian Rabbitries, Colchester, England
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Fasting period before study: Not reported
- Housing: Individually in metal cage with wire mesh floor and maintained at 18 ± 2 ºC and 50 ± 5 % RH.
- Diet (e.g. ad libitum): Ad lib (SG-1 diet)
- Water (e.g. ad libitum): Ad lib
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2 ºC
- Humidity (%): 50 ± 5 % RH
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
IN-LIFE DATES: From: To: Not reported - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Solutions were prepared daily as a series of graded aqueous solutions so that within each study animals in all groups were dosed orally by intragastric intubation at a standard volume. Control animals were dosed with water.
DIET PREPARATION
- Rate of preparation of diet (frequency): N/A
- Mixing appropriate amounts with (Type of food): N/A
- Storage temperature of food: N/A
VEHICLE
- Justification for use and choice of vehicle (if other than water): N/A
- Concentration in vehicle: N/A
- Amount of vehicle (if gavage): Not reported
- Lot/batch no. (if required): N/A
- Purity: N/A - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- N/A
- Details on mating procedure:
- - Impregnation procedure: Co-housed - details not reported
- Proof of pregnancy: Observation of coitus - Duration of treatment / exposure:
- Dosing commenced on Day 6 (Day 0 = confirmation of mating) and continued up to and including Day 18
- Frequency of treatment:
- Daily
- Duration of test:
- 29 days
- Dose / conc.:
- 0.2 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 600 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Females: 13
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: 0.2 and 2.0 mg/kg/day were chosen as likely maximum human intake estimates (from detergents). 300 and 600 mg/kg/day were investigated to provoke obvious adverse effects, the pattern of which would help in assessing the relevance of any marginal differences that might occur at the lower tested concentrations.
- Rationale for animal assignment (if not random): Not reported
- Other: N/A - Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule: 'Regularly'
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): N/A
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): N/A
POST-MORTEM EXAMINATIONS: Yes
- Conducted on all animals either at death (during the test) or at test termination.
OTHER: N/A - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: N/A - Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [all per litter]
- Skeletal examinations: Yes: [all per litter]
- Head examinations: No - Statistics:
- Differences in mean values were statistically analysed by non-parametric methods (Wilcoxon test) since litter values rarely, if ever, follow a normal (Gaussian) distribution; in all analyses the litter was considered as the basic sample unit.
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Toxic effects were generally associated with a principal disturbance of the gastrointestinal tract. Affected rabbits showed diarrhoea, anorexia, weight loss and cachexia prior to death (moribund animals were killed for humane reasons); total litter loss (abortion and/or total resorption) tended to occur as a secondary consequence of the primary effect on the mother.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Mortality was only observed in the highest two concentration groups; 1/13 and 11/13 in the 300 and 600 mg/kg/day test groups, respectively.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Retarded weight gain observed in the 300 mg/kg/day test group and weight loss observed in the 600 mg/kg/day.
- 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:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Details on results:
- Strong toxic effects were observed in rabbits treated at the highest test concentration including; diarrhoea, anorexia, weight loss and cachexia prior to death. 11/13 individuals died during the course of the study in the 600 mg/kg/day test group, in comparison to 2/13 and 1/13 in the control and 300 mg/kg/day test groups, respectively.
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Changes in number of pregnant:
- no effects observed
- Other effects:
- not examined
- Details on maternal toxic effects:
- At the maternally toxic dose of 600 mg/kg/day, there was an increase in foetal loss and reduced litter size, due almost entirely to total litter losses. These factors were deemed to be a secondary consequence of the maternal reaction to the test item, indicated by the fact that among the rabbits bearing young at termination litter parameters were comparable to the control group.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- mortality
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A higher incidence of rabbit pups with extra ribs in the 300 mg/kg/day treatment group was observed. The degree of incidence was within the normal historical laboratory range so this effect was deemed to be non-significant.
- Visceral malformations:
- no effects observed
- Other effects:
- not examined
- Details on embryotoxic / teratogenic effects:
- The incidence of major, minor, visceral and skeletal abnormalities was unaffected in rabbit pups. A statisticaly significant increase in the number of pups with extra ribs was observed in the 300 mg/kg/day test group. The degree of incidence was within the normal historical laboratory range so this effect was deemed to be non-significant.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 600 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- Conclusions:
- The lowest NOAEL that could be determined for maternal toxicity was 300 mg/kg/day based on adverse clinical signs and mortality observed in the 600 mg/kg/day group.
The NOAEL for developmental toxicity could not be established due to the absence of adverse toxic effects at the highest concentration i.e. > 600 mg/kg/day.
This result is appropriate under a read-across approach for applicability to the target substance sodium octane-1-sulphonate monohydrate. - Executive summary:
Alcohol sulphate was examined for potential teratogenic and embryotoxic activity in rabbits. The test item was administered by oral gavage during days 6-18 pregnancy. Dosages employed were 0.2, 2.0, 300 and 600 mg/kg/day with each group consisting of 13 female individuals (New Zealand White).
Maternal toxicity was observed in animals treated at 600 mg/kg/day and was generally with a principle disturbance of the gastrointestinal tract, resulting in diarrhoea, anorexia, weight loss and cachexia prior to death.At the maternally toxic dose of 600 mg/kg/day, there was an increase in foetal loss and reduced litter size, due almost entirely to total litter losses. These factors were deemed to be a secondary consequence of the maternal reaction to the test item, indicated by the fact that among the rabbits bearing young at termination litter parameters were comparable to the control group
The incidence of major, minor, visceral and skeletal abnormalities was unaffected in rabbit pups. A statistically significant increase in the number of pups with extra ribs was observed in the 300 mg/kg/day test group. The degree of incidence was within the normal historical laboratory range, so this effect was deemed to be non-significant.
The lowest NOAEL that could be determined for maternal toxicity was 300 mg/kg/daybased on adverse clinical signs and mortality observed in the 600 mg/kg/day group.
The NOAEL for developmental toxicity could not be established due to the absence of adverse toxic effects at the highest concentration i.e. > 600 mg/kg/day.
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH - See document attached in Section 13.2 for analogue read-across justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- mortality
- Key result
- Abnormalities:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 600 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- The lowest NOAEL that could be determined for maternal toxicity was 300 mg/kg/day based on retarded weight gain and mortality observed in the 600 mg/kg/day group.
The NOAEL for developmental toxicity could not be established due to the absence of adverse toxic effects at the highest concentration i.e. > 600 mg/kg/day.
The target result corresponds to the source result from a study on a structural analogue. - Executive summary:
See document attached in Section 13.2 for analogue read-across justification.
Alcohol sulphate was examined for potential teratogenic and embryotoxic activity in rats. The test item was administered by oral gavage during days 6-15 pregnancy. Dosages employed were 0.2, 2.0, 300 and 600 mg/kg/day with each group consisting of 20 female individuals (CRL:CD).
Mild maternal toxicity was observed in animals treated at 600 mg/kg/day and was generally with a principle disturbance of the gastrointestinal tract, resulting in retarded weight gain. Rats showed no treatment-related total litter losses. Values for litter size and foetal loss were unaffected even at dosages providing evidence of maternal toxicity (600 mg/kg/day).
The incidence of major, minor, visceral and skeletal abnormalities was unaffected in rat pups. A statistically significant reduction in the number of pups with extra ribs was observed in the 600 mg/kg/day test group. The significance of this value was largely attributable to a relatively high incidence of extra-ribbed pups among the control group. The number of pups with additional ribs for all test groups was within the expected normal laboratory range.
The lowest NOAEL that could be determined for maternal toxicity was 300 mg/kg/day based on retarded weight gain and mortality observed in the 600 mg/kg/day group.
The NOAEL for developmental toxicity could not be established due to the absence of adverse toxic effects at the highest concentration i.e. > 600 mg/kg/day.
Referenceopen allclose all
Table 2 Summary of maternal performance
Observation |
Number of animals at dosage |
||||
Control |
0.2 mg/kg/day |
2.0 mg/kg/day |
300 mg/kg/day |
600 mg/kg/day |
|
Mated |
13 |
13 |
13 |
13 |
13 |
Died |
2 |
0 |
1^ |
1 |
11 |
Non-pregnant |
1 |
1 |
2 |
1 |
0 |
Total litter loss |
0 |
1 |
0 |
2 |
0 |
With viable young |
10 |
11 |
10 |
9 |
2 |
Bodyweight change |
- |
retarded gain |
- |
retarded gain |
loss |
Table 3 Group mean litter data
Dosage (mg/kg/day) |
Number of litters ^ |
Litter size (of viable young) |
Embryonic deaths |
Implantations |
Corpora lutea |
Embryonic loss % |
Litter weight (g) |
Foetal weight (g) |
|
Pre-implantation |
Post-implantation |
||||||||
0 |
A=B=10 |
7.3 |
0.5 |
7.8 |
10.7 |
27.2 |
4.3 |
295.7 |
43.1 |
0.2 |
A=12 B=11 |
7.1 7.7 |
0.8 0.4 |
7.8 8.1 |
9.2 9.5 |
12.8 12.5 |
13.9 6.1 |
- 331.3 |
- 43.5 |
2.0 |
A=B=10 |
9.0 |
1.3 |
10.3 |
10.7 |
3.8 |
12.8 |
332.6 |
37.1 |
300 |
A=11 B=9 |
7.7 9.4 |
2.4 0.6 |
10.1 10.0 |
10.8 10.8 |
6.3 6.8 |
22.7 5.6 |
- 357.3 |
- 37.9 |
600 |
A=B=2 |
8.0 |
2.0 |
10.0 |
11.0 |
9.1 |
18.2 |
297.2 |
37.1 |
^ Mean A = includes all surviving animals showing evidence of implantation, including those with total litter loss
^ Mean B = includes only animals bearing viable young at termination
Table 4 Group mean incidence of major malformations and minor anomalies
Dose (mg/kg/day) |
Number of young |
Incidence of pups with extra lumbar ribs (mean %) ^ |
||||||||
Major malformations |
Minor anomalies^ |
|||||||||
Examined |
Affected |
Gross or visceral |
Skeletal |
|||||||
Total number |
Mean % |
Examined |
Affected |
Examined |
Affected |
|||||
Total number |
Mean % |
Total number |
Mean % |
|||||||
0 |
73 |
0 |
0 |
73 |
5 |
6.3 |
73 |
2 |
2.2 |
33.6 |
0.2 |
85 |
0 |
0 |
85 |
0 |
0 |
85 |
13 |
13.1 |
46.9 |
2.0 |
90 |
1 |
1.1 |
89 |
7 |
8.6 |
89 |
20 |
22.9 |
79.6* |
300 |
85 |
0 |
0 |
85 |
3 |
4.2 |
85 |
8 |
9.4 |
63.5 |
600 |
16 |
0 |
0 |
16 |
1 |
5.6 |
16 |
2 |
14.3 |
85.7 |
^ young showing major malformations excluded
* Wilcoxon test (p < 0.05)
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rabbit
- Quality of whole database:
- A reliable study consistent with information requirements at the registered tonnage band is utilised to fulfill this endpoint requirement.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Sodium dodecyl sulphate (read-across source substance) was examined for potential teratogenic and embryotoxic activity in rabbits. The test item was administered by oral gavage during days 6-18 pregnancy. Dosages employed were 0.2, 2.0, 300 and 600 mg/kg/day with each group consisting of 13 female individuals (New Zealand White).
Maternal toxicity was observed in animals treated at 600 mg/kg/day and was generally with a principle disturbance of the gastrointestinal tract, resulting in diarrhoea, anorexia, weight loss and cachexia prior to death. At the maternally toxic dose of 600 mg/kg/day, there was an increase in foetal loss and reduced litter size, due almost entirely to total litter losses. These factors were deemed to be a secondary consequence of the maternal reaction to the test item, indicated by the fact that among the rabbits bearing young at termination litter parameters were comparable to the control group
The incidence of major, minor, visceral and skeletal abnormalities was unaffected in rabbit pups. A statistically significant increase in the number of pups with extra ribs was observed in the 300 mg/kg/day test group. The degree of incidence was within the normal historical laboratory range, so this effect was deemed to be non-significant.
The lowest NOAEL that could be determined for maternal toxicity was 300 mg/kg/daybased on adverse clinical signs and mortality observed in the 600 mg/kg/day group.
The NOAEL for developmental toxicity could not be established due to the absence of adverse toxic effects at the highest concentration i.e. > 600 mg/kg/day.
Mode of Action Analysis / Human Relevance Framework
Not applicable, no reproductive or developmental effects observed in the available study.
Justification for classification or non-classification
The substance does not meet the criteria for classification in accordance with Regulation (EC) No 1272/2008 (CLP).
Additional information
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.

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