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EC number: 939-707-2 | CAS number: -
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is sufficiently documented. Few deviations from the current guidelines were noted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- 5-week treatment period instead of 4. Histopathology was conducted only on a selection of organs collected at necropsy. No analytical verifications of the doses administered.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- sodium diisobutylnaphtalene sulfonate
- Cas Number:
- 91078-64-7
- IUPAC Name:
- sodium diisobutylnaphtalene sulfonate
- Test material form:
- other: liquid
- Details on test material:
- See confidential details on test material section
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:SPF. BOR: WISW (SPF CPB) of the breeder Winkelmann (Borchen)
- Age at study initiation: the rats were 5-6 weeks old
- Weight at study initiation: males: a mean body weight of 105 g, and female a mean body weight of 96 g.
- Fasting period before study: no
- Housing: The animals were placed in a traditional way each cage Makrolon Type II (and Gönnert SPIEGEL, 1961) on wood pellets free of dust.
- Diet (e.g. ad libitum): During the test, the animals received during the weekly cage change their weekly amount of food in the form of granules costs (Altromin 1324 Manufacturer: Altrogge GmbH, Lage).
- Water (e.g. ad libitum): The animals had free access to deionized drinking water, which was diluted test substancel.
- Acclimation period: the animals were acclimated for a period of 12 days before the beginning of the treatment period.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 10%
- Air changes (per hr): no
- Photoperiod (hrs dark / hrs light): rhythm day / night 12 hours (artificial light from 6 to 18 pm CET)
IN-LIFE DATES: no data available
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test substance was diluted once a week in deionized water. To dissolve the deposits present at the bottom, it was heated to approx. 50 ° C. The control subjects received only de-ionized water.
VEHICLE
- de-ionized water
- Concentration in vehicle: 100, 500, 2500 ppm - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 5-weeks
- Frequency of treatment:
- not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 500, 2500 ppm
Basis:
nominal in water
- No. of animals per sex per dose:
- 10 males and 10 females rats
- Control animals:
- yes
- Details on study design:
- ERKANTOL BXG was diluted once a week in deionized water in the following concentrations: 0 (control), 100, 500 and 2500 ppm by reference to the amount of 22% of test substance.
It was not advisable to use tap water, because with high concentrations it presented a phenomenon of turbidity with precipitation.
The concentrations were chosen based on the results of a pre-test only for a period of one week.
For each dose, the test group consisted of 10 male rats and 10 female rats.
The test substance was diluted once a week in deionized water. To dissolve the deposits present at the bottom, it was heated to approx. 50 ° C. The control subjects received only de-ionized water.
At the beginning of the test, the male and female rats were sorted into two weight groups (light, heavy) and divided into groups corresponding doses based on a random list. Finally, the animals were numbered consecutively. - Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: 2 times a day on weekdays and once a day on weekends and holidays
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: 2 times a day on weekdays and once a day on weekends and holidays
BODY WEIGHT: Yes
- Time schedule for examinations: at the beginning of the test and weekly
FOOD CONSUMPTION: Yes
The daily food intake was determined by weighing again the amount of uneaten food.
WATER CONSUMPTION: Yes
- Time schedule for examinations: The daily intake of water was determined by measuring the amount of new non-drinking water.
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: during the 4th week of test
- Anaesthetic used for blood collection: Yes , ether
- Animals fasted: Yes
- How many animals: 5 males and 5 females of each group
- Erythrocyte count and leukocyte count: counting by Coulter Counter, number of platelets: measurement by TOA PL 100 system, hemoglobin concentration and mean cell volume (MCV): Measurement with a Coulter counter, hematocrit, mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC): Calculation with a Coulter counter, blood count based on smear (modified Wright staining method) thromboplastin time test method according HEENE Hepato-Quick (1974).
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: during the 4th week of test
- Animals fasted: Yes
- How many animals: 5 males and 5 females of each group. Due to the suspicious nature of the results, in the fifth week of the test, we measured the concentration of inorganic phosphate on the 5 male rats and the remaining five female rats from each group.
- Enzyme activity in plasma: Alkaline phosphates (ALP), Glutamate-Oxaloacetate-Transaminase (GOT) and glutamate-pyruvate-transaminase (GPT), as recommended by the Deutsche Gesellschaft für Klinische Chemie (1972)
- Substrates in plasma: Creatinine according FABINY and ERTINGSHAUSEN (1971); Urea and BERGMEYER by Gutmann (1974); Glucose by SCHMIDT (1961); Cholesterol in TRINDER (1969); Bilirubin according WAHLEFELD et al. (1972); total albumin according WEICHSELBAUM (1946).
- Electrolytes in serum:Sodium, potassium and calcium determination by flame photometry; Chloride according LANGE LANGE und BORNER (1972);
Inorganic phosphate according DALY and ERTINGSHAUSEN (1972).
URINALYSIS: Yes
- Time schedule for collection of urine: during the 4th week of test. The urine was collected for periods of approx. 16 hours.
- Animals fasted: Yes
- Urinalysis: Semi-quantitative: Glucose, blood, albumin, bilirubin, ketones and pH using sticks Bili-Labstix; Urobilinogènes with Urobilistix, microscopic examinations of sediment after centrifugation of the urine sample; Quantitative: volumes over time; Albumin according RICHTERICH (1968) Specific gravity by digital density meter (DMA 45, Paar Heraeus soc.).
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Autopsy of rats died during the test:
The rats died during the treatment period were dissected and subjected to macroscopic evaluation. The organs and tissues listed below were treated with Bouin's solution.
Autopsy of rats killed after the test:
All surviving rats were anesthetized with diethyl ether and killed by exsanguination. During the autopsy, the animals were submitted to a pathologico-anatomical examination. The following organs were weighed: brain, heart, testis, lung, liver, spleen, adrenal glands and kidneys.
Preparations of the following organs of all subjects in all groups were treated in a Bouin's solution: aorta, eyes, intestines (duodenum, jejunum, ileum, cecum, colon, rectum), femoral block with skeletal muscle and sciatic nerve, brain, bladder, heart, testis, pituitary gland, salivary gland, lung, lymph nodes (mesenteric and cervical), stomach, spleen, epididymis, adrenal glands, esophagus, ovary, pancreas, prostate, seminal vesicle, the thyroid with parathyroid glands, sternum, thymus, trachea and uterus and all macroscopically visible changes. The liver and kidneys of 5 males and 5 females in each group were also preserved in Bouin's solution. Pieces of liver of these subjects were also preserved by fixation with formalin-calcium. The liver, kidneys and abdominal adipose tissue of other animals were frozen for possible future evaluation.
HISTOPATHOLOGY: Yes
Histopathological examination of the bones (femur, sternum with marrow), heart, liver, spleen, adrenal glands, kidneys and thyroid with parathyroid glands was performed for 5 male rats and five female rats of groups 0 and 2500 ppm. - Other examinations:
- no other examination
- Statistics:
- - Calculation of the arithmetic mean value of each group, the standard deviation , the confidence limits for the confidence level 95% and 99%.
- Comparison of values for the test item-treated and the control groups performed with the significance test (U-test) (MANN, WHITNEY and Wilcoxon (significance thresholds 5% and 1%)).
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight was not affected by the test item in male given 100 and 500 ppm and in females whatever the dose level. Mean body weight gain was slightly delayed in males of group 2 500 ppm (not statistically significant).
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- 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:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Food and water intake, general behaviour and mortality were not affected by treatment with the test item. Body weight gain was slightly reduced only in male rats given 2500 ppm (up to 6% v.s. control, not statistically significant).
Up to 2500 ppm, hematological, plasma chemistry and urinary parameters were not affected by the test item.
No test item-related effects were reported at necropsy or during histopathological examinations up to the highest dose level.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 317.05 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Remarks on result:
- other: no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 335.22 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Remarks on result:
- other: no effects observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table: Results
|
DOSE ppm |
|||
0 |
100 |
500 |
2500 |
|
MALE FOOD INTAKE g/animal/day |
20 |
20 |
20 |
20 |
FEMALE FOOD INTAKE g/animal/day |
15 |
15 |
16 |
16 |
|
DOSE ppm |
|||
0 |
100 |
500 |
2500 |
|
MALE WATER CONSUMPTION ml/animal/day |
26 |
24 |
24 |
24 |
MALE TEST COMPOUND INTAKE mg/animal/day mg/kg b.w./day |
|
2.36 11.99 |
11.87 61.36 |
59.88 317.05 |
FEMALE WATER CONSUMPTION ml/animal/day |
22 |
20 |
18 |
19 |
FEMALE TEST COMPOUND INTAKE mg/animal/day mg/kg b.w./day |
|
2.05 14.57 |
9.15 64.78 |
46.72 335.22 |
Haematology 4 weeks |
|||||||||
Dose ppm |
LEU GIGA/L |
ERY TERA/L |
HGB G/L |
MCV FL |
THROM GIGA/L |
THP SEC |
HCT L/L |
MCH PG/E |
MCHC G/L |
Male 0 100 500 2500 |
10.2 10.6 9.8 10.3 |
7.43 7.62 7.52 7.69 |
154 152 153 155 |
61 60 62 61 |
1048 1098 1174 1120 |
30.5 30.4 31.4 29.3 |
0.46 0.46 0.47ns 0.47** |
20.7 19.9 20.3 20.2 |
338 330** 328* 330ns |
Female 0 100 500 2500 |
8.1 7.7 7.0 7.3 |
7.43 7.29 7.45 7.42 |
151 146 151 151 |
62 61 61 61 |
1098 1027 1079 1094 |
28.7 29.4 30.5 29.2 |
0.46 0.44 0.46 0.45 |
20.3 20.0 20.2 20.4 |
330 329 331 332 |
Differential blood count (%) 4 weeks |
||||||||
Dose ppm |
BASO |
EOSIN |
IPC JGL |
STAB |
SEGM |
LYM |
MONO |
PLAS |
Male 0 100 500 2500 |
0.0 0.0 0.0 0.0 |
0.2 0.4 0.4 0.2 |
0.0 0.0 0.0 0.0 |
0.0 0.0 0.0 0.0 |
10.2 8.8 7.6** 7.0* |
89.6 90.8 92.0* 92.8ns |
0.0 0.0 0.0 0.0 |
0.0 0.0 0.0 0.0 |
Female 0 100 500 2500 |
0.0 0.0 0.0 0.0 |
0.8 0.4 0.8 0.4 |
0.0 0.0 0.0 0.0 |
0.0 0.0 0.0 0.0 |
6.0 5.8 8.8 8.2 |
93.2 93.8 90.4 91.4 |
0.0 0.0 0.0 0.0 |
0.0 0.0 0.0 0.0 |
Clinical chemistry 4 weeks |
||||||||||||||
Dose ppm |
ALP U/L |
GOT U/L |
GPT U/L |
BILI µMOL/L |
PROT/P G/L |
UREA MMOL/L |
CREA µMOL/L |
CHOL MMOL/L |
GLUC MMOL/L |
AN.PH MMOL/L |
NA MMOL/L
|
K MMOL/L |
CA MMOL/L |
CL MMOL/L |
Male 0 100 500 2500 |
497 437** 430ns 587 |
63.1 47.8 44.8* 46.5 |
54.1 50.8 57.3 49.2 |
2.1 2.1 2.4 2.4 |
54.7 53.5 54.6 56.3 |
7.72 7.36 7.72 8.36 |
40 48 59 43 |
1.98 2.03 1.91 1.91 |
5.49 5.51 5.33 5.46 |
2.48 2.39 2.21** 2.06** |
140 139 139 143 |
5.0 5.2 4.9 4.8 |
2.75 2.78 2.67 2.76 |
102 101 103 103 |
Female 0 100 500 2500 |
316 321 305 337 |
43.4 48.5 42.3 52.0 |
45.7 51.6 52.6 45.5 |
2.0 2.2 2.2 1.9 |
57.6 54.6 54.4 53.0 |
8.40 8.19 7.37* 9.27 |
54 42 47 45 |
2.02 1.71* 1.72 1.72 |
5.22 5.33 5.66 5.18 |
2.03 1.87 1.71* 1.57** |
141 140 140 141 |
4.4 4.5 4.6 4.2 |
2.73 2.73 2.68 2.67 |
102 103 103 104 |
Quantitative urinalyses 4 weeks |
|||
Dose ppm |
PROTU MG/16H |
VOL ML |
SP.GR. G/L |
Male 0 100 500 2500 |
12.35 9.46 7.71 6.48** |
35 21 13** 6** |
1004 1007 1013 1030** |
Female 0 100 500 2500 |
2.27 1.22ns 1.35* 1.23* |
11 5 4* 4* |
1010 1024 1034** 1037 |
Absolute organ weights (mg) |
|||||||||
Dose ppm |
BODY-W (G) |
HEART |
LUNG |
LIV |
SPLE |
KIDN |
ADRE |
TEST |
BRAIN |
Male 0 100 500 2500 |
242 243 240 230 |
783 765 756 711 |
1032 1040 1075 988 |
9837 10474 10414 9747 |
484 482 492 474 |
1638 1785* 1682 1714 |
39 40 39 41 |
2915 2921 2991 2994 |
1660 1653 1667 1633 |
Female 0 100 500 2500 |
173 162 166 162 |
592 590 588 570 |
868 806 838 792* |
7516 6952 7245 7341 |
408 379 366 373 |
1237 1218 1313 1330 |
58 60 57 60 |
|
1617 1652 1658 1652 |
Relative organ weights (mg/100g) |
|||||||||
Dose ppm |
BODY-W (G) |
HEART |
LUNG |
LIV |
SPLE |
KIDN |
ADRE |
TEST |
BRAIN |
Male 0 100 500 2500 |
242 243 240 230 |
324 315 317 309 |
427 428 450 430 |
4063 4298 4328 4232 |
201 198 207 205 |
679 734* 700 746* |
16 17 17 18 |
1213 1204 1256 1305 |
690 683 702 712 |
Female 0 100 500 2500 |
173 162 166 162 |
342 366 357 352 |
504 500 507 488 |
4350 4291 4369 4514 |
236 232 222 229 |
717 756 796** 819** |
33 37 35 37 |
|
940 1027* 1008 1023** |
Ns : not significant
Significant differences compared to the control group are marked with an asterisk (*) p ≤ 0.05 by two asterisks (**) for p ≤ 0.01.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test item Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda induced only a slight reduction of body weight gain in males at the dose of 2500 ppm. In the absence of other test item-related changes, this slight variation is considered of no toxicological relevance. The NOAEL was therefore considered to be 2500 ppm (equivalent to 317.05 and 335.22 mg/kg b.w./day in males and females, respectively). Therefore no classification as STOT-RE is required according to the Regulation (EC) 1272/2008 (CLP) and as harmful after repeated dose exposure according to the Directive 67/548/EEC.
- Executive summary:
In a repeated dose toxicity study by the oral route, the test item was administered in drinking water to rats (10 animals/sex/dose) at doses of 0; 100; 500 and 2500 ppm during 5 weeks.
Food and water intake, general behaviour and mortality were not affected by treatment. Body weight gain was slightly reduced only in male rats administered 2500 ppm (not statistically significant) but this variation was considered of no toxicological relevance owing to its minimal magnitude (maximum 6% v.s. control) and absence of associated test item-related variations. Up to 2500 ppm, hematological, plasma chemistry and urinary parameters were not affected by the test item. No test item-related effects were reported at necropsy or during histopathological examinations up to the highest dose level.
Based on the results of this study, 2500 ppm of test item, which corresponds to 317.05 and 335.22 mg/kg b.w./day in males and females, respectively, was established as the No Observed Adverse Effect Level (NOAEL). Therefore, reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is not classified for repeated dose toxicity according to the classification criteria of the Regulation (EC) 1272/2008 (CLP) and of the Directive 67/548/EEC.
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