Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-257-8 | CAS number: -
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Method: other: 10 rats/group and sex
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- C14-17 alkanes, sec-mono- and disulfonic acids, phenyl esters
- EC Number:
- 701-257-8
- IUPAC Name:
- C14-17 alkanes, sec-mono- and disulfonic acids, phenyl esters
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Bor: WISW
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: test substance administered with food
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
750; 3000; 12000 ppm (dosage males: 55.4; 228.0; 985.2 mg/kg b.w./day (calculated) dosage females: 68.7; 282.6; 1488.5 mg/kg b.w./day (calculated))
Basis:
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- 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
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 3 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: In the highest dose group of 12000 ppm the female rats consumed more food and the male rats had an increased water consume and a slightly increased tromboplastin-time was observed in male rats at 12000 ppm.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
RM-Freetext:
dosage males: 55.4; 228.0; 985.2 mg/kg b.w./day
(calculated)
dosage females: 68.7; 282.6; 1488.5 mg/kg b.w./day
(calculated)
no death, no effect on behaviour, reduced body weight gain, increased feed
(females) and water consumption (males) at the high dose level, absolute and
relative liver weight is significantly dose-related increased at all dose
levels, kidney weight only increased at the high dose level, no
substance-related histopathological effects (47 organs and tissue),
opthalmological, hematological and clinical- chemical parameters within the
normal range, slightly increased tromboplastin/time at the high dose.
Applicant's summary and conclusion
- Executive summary:
In a subchronical 3 month-feeding study male and female rats received the test substance via food in following doses: 0 (control-group); 750; 3000; 12000 ppm.
No mortalities and no effects on behaviour were observed.
Food and water intake were not modified up to 3000 ppm. In the highest dose group of 12000 ppm the female rats consumed more food and the male rats had an increased water consume.
The growth was delayed in male and femal rats in the highest dose group.
The absolute and relative liver weight was significantly dose-related increased at all dose levels, but the kidney weight only increased at the high dose level. No substance related histopatological effects (aorta, eyes with lids, cecum, duodenum, femur, brain, bladder, testicles, skin, heart, pituitary gland, larynx, head, ileum, jejunum, liver, lung, mesenterial lymph node, mandibular lymph node, stomach, lactiferous gland, spleen, femoral musculature, epididymis, nervus ischiadicus, nervus opticus, kidneys, esophagus, ovaries, oviduct, pancreas, prostata, rectum, cervical, thoracal and lumbal spinal cord, seminal vesicle, thyroid gland, salivary gland, sternum, thymus (if present), trachea, extraorbitary lacrimal gland, uterus, vagina, tongue) were observed.
Ophtalmological, hematological and clinical parameters were within the normal range.
Only a slightly increased tromboplastin-time was observed in male rats at 12000 ppm.
The NOAEL for male and female rats therefore is 3000 ppm.
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.
