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EC number: 939-368-0 | 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
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Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from August 1993 to 11 September 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was performed on the analogue substance "Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda". Both substances are composed by mono, di and tri alkylnaphthalenesulfonate sodium salts, with a carbon chain length equal to 3 carbons for «Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda» or 4 carbons for «Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda». It is assumed that the difference of alkyl length of the naphthalene substituent's is not significant in respect of toxicological properties under consideration based on the fact these two lengths of alkyl chains are short and very close to each other. This prediction is supported by some toxicological data available on both substances (data not shown). The study was performed according to EU / OECD guidelines and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- sodium diisobutylnaphtalene sulfonate
- Cas Number:
- 91078-64-7
- IUPAC Name:
- sodium diisobutylnaphtalene sulfonate
- Reference substance name:
- Reference substance 001
- EC Number:
- 939-707-2
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- See confidential details on test material section
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann, Borchen
- Age at study initiation: not documented
- Weight at study initiation: 187 to 236 g
- Fasting period before study: no
- Housing: During the adaptation period, the females were kept in groups in Type III Makrolon cages, and starting from gestation day 0 they were iindividually accomodated in Type II Makrolon cages on low-dust wood shavings supplied by ssniff GmbH in Soest.
- Diet (e.g. ad libitum): standard diet (Altromin 1324) given ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 7 days before mating.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): at least 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial lighting from 6 a.m. to 6 p.m.
IN-LIFE DATES: From: 24 Aug 1993 To: 27 Oct 1993
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Administration formulations (solutions) were prepared with demineralised water. The stability (over 8 days) of the active ingredient in the formulations were analytically verified before initiation of the study. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- A content check of the formulations in all dose levels was carried out. The results revealed no significant devioations of the active ingredient content from the nominal value in the formulations.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 2 females with one male
- Length of cohabitation: one night
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- Any other deviations from standard protocol: no - Duration of treatment / exposure:
- from day 6 to day 15 p.c.
- Frequency of treatment:
- daily
- Duration of test:
- see above
- No. of animals per sex per dose:
- 27 females/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The dose levels were selected according to a preceding range-finding study in 5 rats per group with doses of 200, 300, 400 and 500 mg/kg bw. From the dose of 300 mg/kg and above breathing sounds, decreased feed intakes and body weight gains were observed (300 mg/kg marginally). One dam of the 400 mg/kg group died and all dam of the 500 mg/kg group revealed bloody snouts and decreased motility. The resorption rate and the external examination of the fetuses revealed no embryotoxic potential up to and including 500 mg/kg.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: from day 0 to 20 p.c. all animals were inspected twice daily on the basis of their appearance and behavior and not was given to any alterations in the excretory products.
DETAILED CLINICAL OBSERVATIONS:
- Time schedule:see above
BODY WEIGHT: Yes
- Time schedule for examinations: on day 0 p.c., daily from day 6 to 15 p.c and on day 20 pc.
FOOD CONSUMPTION: Yes
The quantity of food consumed for each female was recorded for the following intervals: days 0-6, 6-11, 11-16 and 16-20 p.c.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: gross pathological evaluation (no further details) - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes / No / No data
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: - Fetal examinations:
- - External examinations: Yes, all fetuses
- Soft tissue examinations: Yes, evaluation of about half of the fetuses.
- Skeletal examinations: Yes, evaluation of about half of the fetuses.
- Head examinations: No data
- External examinations: Yes: [all per litter / half per litter / #? per litter ] / No / No data
- Soft tissue examinations: Yes: [all per litter / / #? per litter ] / No / No data
- Skeletal examinations: Yes: [all per litter / half per litter / #? per litter ] / No / No data
- Head examinations: Yes: [all per litter / half per litter / #? per litter ] / No / No data - Statistics:
- Animals that had no implantation sites were not used for statistical evaluation. For calculation of body weight gain, feed intakes and fetal parameters only dams with living fetuses were used.
Statistical significance was tested using the following methods:
a. Fisher's exact significance test at significance levels of alpha = 5% and alpha = 1% (two-tailed) was used for the:
- fertility rate
-gestation rate
b. The F-test, and t-test or Welch t-test were used for the:
- feed intakes
- Body weight gains
- Corrected body weight gains
- Number of corpora lutea per dam
- Number of implantations per dam
- Number of live fetuses per dam
- Percentage of live fetuses in proportion to the number of implantations per dam
- Number of male or female fetuses per dam
- Fetal weights per group and per dam
- Placental weights per group and per dam
c. The Yates-corrected Chi2 test was used for the:
- Number of fetuses or litters exhibiting malformations
- Pre-implantation loss per dam
- Number of male or female fetuses per group
- Number of resorptions per dam
d. 2 by N CHI2-test; in case of signficant differences Fisher's exact test with Bonferonni correction for:
- Number of fetuses or litters with skeletal findings. - Indices:
- see Statistics section
- Historical control data:
- Historical control data were provided to allow comparison with concurrent controls. These included data for clinical signs, pathological and anatomical findings, food consumption during pregnancy, placenta findings, fertility and pregnancy index, caesarian section data, summary of reproduction data, number of malformations, spontaneous malformations, external and visceral deviations of fetuses, skeletal retardations and 14th rib, skeletal findings of fetuses/litters.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes. Remark: Reduced body weight gain and feed intake at 60 and 360 mg/kg
Details on maternal toxic effects:
The following parameters of maternal toxicity were impaired: The body weight gain in the 60 and 360 mg/kg group dams and the feed intake in the 360 mg/kg group (60 mg/kg marginally) were reduced during the treatment period (details in Tables 1 and 2). Decreased water consumption and reduced feces excretion were observed in some dams of the 360 mg/kg group.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes. Remark: Increased numbers of fetuses with skeletal variations and retardations were observed at 360 mg/kg
Details on embryotoxic / teratogenic effects:
The following parameters of intrauterine development were affected: In the 360 mg/kg group increased numbers of placentas with necrotic border and slightly reduced placental weights were observed (details below and in Table 4). In the 360 mg/kg group increased numbers of fetuses with skeletal variations and retardations were observed (details below and in Table 5).
At the dose of 360 mg/kg b.w. increased incidences of vertebral and multiple malformations that may occur spontaneously were evident, while the overall incidence of malformations was comparable between control and 360 mg/kg group. A treatment related effect for this slightly different distribution cannot be excluded.
However, primary developmental toxicity was not evident, since all embryotoxic findings observed at the dose of 360 mg/kg appeared in a maternally toxic dose range.
Effect levels (fetuses)
- Remarks on result:
- other: The mean number of fetuses were not affected by the treatment up to and including the dose of 360 mg/kg.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Appearance, behavior and mortality:
Appearance, behavior and mortality of the dams were unaffected up to and including the dose of 360 mg/kg b.w.
Gross pathological findings in dams:
No treatment related findings were evident at necropsy up to and including the dose of 360 mg/kg b.w.
General Reproduction data:
The number of corpora lutea, preimplantation losses and implantations was comparable in all experimental groups, with exception of the significantly lower preimplantation losses in the 360 mg/kg group (details in Table 3).
Gestation rate:
The gestation rate was unaffected by the treatment with doses up to and including 360 mg/kg.
Weight and appearance of placentas:
The placental weight was statistically significantly decreased at the dose of 360 mg/kg when calculated on litter basis and from 60 mg/kg and above when calculated in individual basis.Since the toxicologically more relevant calculation on litter basis was not affected at the dose of 60 mg/kg and as the values even of the 360 mg/kg group lay within the range of historical control data, the statistical significance at 60 mg/kg is not regarded as toxicologically relevant and even the values obtained at the dose of 360 mg/kg as equivoqual. Nevertheless, together with the increase number of placentas with necrotic placental borders at 360 mg/kg, this dose is considered to be the effect level for placental weight and appearance (details in Table 4).
Resorption rate, number of fetuses:
The resorption rate and the mean number of fetuses were not affected by the treatment up to and including the dose of 360 mg/kg.
Sex and fetuses:
The number of male and female fetuses did not differ from those in the controls to any extent at levels up to and including 360 mg/kg.
Fetal weight:
The fetal weight was unaffected by the treatment up to and including 360 mg/kg.
Skeletal system deviations (variations, retardations):
At the highest dose of 360 mg/kg, slightly reduced ossification of the parietal and interparietal bones and the 7th cervical vertebra were observed as well as an increase in the incidence of fetuses with wavy ribs. These findings are considered to be treatment related.
Malformations (details in Table 5):
Neither the type nor the incidence of malformations were affected by treatment with doses up to and including 60 mg/kg.
The number of abnormal fetuses at 360 mg/kg was comparable to the control group. All findings in the control and the 360 mg/kg were also observed in previous controls. Nevertheless, there was a slight difference concerning the distribution of these findings. Microphthalmia mainly observed in the control group of this study occured in comparable incidences in previous controls, while the incidence of vertebral and multiple malformations mainly obtained in the 360 mg/kg group was rather low in previous controls. Therefore a treatment related effect on the incidence of the verteral and multiple malformations cannot be excluded. However, incresed incidences of spontaneoulsy occuring malformations are not regarded as indication of a specific teratogenic potential.
The remaing individual fetal findings (deviations) observed at visceral examinations revealed no evidence of tes substance-related effects in any of the dose troups.
Applicant's summary and conclusion
- Conclusions:
- The test item, Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda was administered by gavage, once daily from days 6 to 15 p.c. to inseminated Wistar rats at doses of 0, 10, 60, or 360 mg/kg/day in a GLP-compliant study in accordance with OECD Guideline 414.
On the basis of the results obtained in this study:
- The No Observed Adverse Effect Levels (NOAEL) for maternal toxicity was 10 mg/kg b.w./day.
- The NOAEL for developmental toxicity was 60 mg/kg b.w./day.
At the dose of 360 mg/kg b.w. increased incidences of vertebral and multiple malformations that may occur spontaneously were evident, while the overall incidence of malformations was comparable between control and 360 mg/kg group. A treatment related effect for this slightly different distribution cannot be excluded. However, primary developmental toxicity was not evident, since all embryotoxic findings observed at the dose of 360 mg/kg appeared in a maternally toxic dose range.
Therefore, in the absence of evident direct embryotoxic effect, the registered substance is not classified for reprotoxicity according to the classification criteria of the Regulation (EC) 1272/2008 (CLP) and of the Directive 67/548/EEC. - Executive summary:
Groups of 27 inseminated Wistar rats each were treated daily orally by gavage with Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda formulated in demineralized water from day 6 to day 15 p.c. in doses of 0, 10, 60, or 360 mg/kg body weight, respectively. The fetuses were delivered by cesarian section on the 20th day of gestation. Investigations were performed to determine the general tolerance of the test substance by the dams, as well as its effect on intrauterine development.
Mortality, behavior and appearance of the dams were not affected by the treatment up to and including 360 mg/kg. The body weight gain in the 60 and 360 mg/kg group dams and the feed intake in the 360 mg/kg group (60 mg/kg marginally) were reduced during the treatment period. Decreased water consumption and reduced feces excretion were observed in some dams of the 360 mg/kg group. There were no test substance-related findings at necropsy in any of the experimental groups.
With respect to intrauterine development, the gestation rate, the resorption rate and accordingly the number of fetuses, and the fetal sex as well as fetal weight were unaffected by the treatment up to and incuding 360 mg/kg.
In the 360 mg/kg group increased numbers of placentas with necrotic border and slightly reduced placental weights were observed.
External, visceral and skeletal examination of the fetuses revealed no treatment related effects on intrauterine development up to and including the dose of 60 mg/kg. At the dose of 360 mg/kg b.w. increased incidences of vertebral and multiple malformations that may occur spontaneously were evident, while the overall incidence of malformations was comparable between control and 360 mg/kg group. A treatment related effect for this slightly different distribution cannot be excluded.
However, primary developmental toxicity was not evident, since all embryotoxic findings observed at the dose of 360 mg/kg appeared in a maternally toxic dose range.
The No Observed Adverse Effect Levels (NOAEL) were thus:
Maternal toxicity : 10 mg/kg b.w./day
Developmental toxicity : 60 mg/kg b.w./day
Therefore, in the absence of evident direct embryotoxic effect, the registered substance is not classified for reprotoxicity according to the classification criteria of the Regulation (EC) 1272/2008 (CLP) and of the Directive 67/548/EEC.
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.
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