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EC number: 941-174-6 | CAS number: -
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Repeated Dose 28-Day Oral Toxicity in Rodents
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1992-07-29 to 1992-08-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents) (27 July 1995)
- Deviations:
- yes
- Remarks:
- highest recommended dose of 1000 mg/kg bw was not included in this study, not all necessary organ weights were taken e.g. heart, thymus, spleen were not evaluated
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
- Cas Number:
- 1079184-43-2
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- Daily, 7 days/week for 4 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1, 10, 500 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: No significant treatment-related effects on reproductive organs (organ weights of ovary and testis and histopathology of gonads) were seen at the highest dose administered.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
In this Repeated Dose, 28-day Oral Toxicity Study performed comparable to OECD guideline 407, 12 May 1981 reaction products of C16-18/C18 unsaturated fatty acid with methyl diethanolamine, MeCl quaternized (10 % a.i aqueous dispersion) was administered to groups of 25 Charles River CD rats male and female by oral gavage at dose levels of 1, 10 and 500 mg/kg bw/day for 28 days. Two other control groups received either deionised water or to pH 2.5 adjusted (HCL) deionised water (vehicle).
All animals survived to study termination. No test substance-related findings were detected or observed in clinical examinations, body weights, food consumption values, opthalmoscopic examinations, haematology, clinical biochemistry or clinical pathology evaluations including organ weights of ovary and testis and histopathology of reproductive organs (gonads, mammary gland (femals only), prostate and seminal vesicle, uterus and vagina).
The no effect level (NOEL) for this study is the high dose level of 500 mg/kg bw/day of the test article.
Applicant's summary and conclusion
- Conclusions:
- The results from the evaluation of reproductive organs, especially organ weights of ovary and testis and histopathology of gonads from this 28-day repeated dose study revealed no indications of any substance-related effects up to and including the highest test dose of 500 mg/kg bw/day.
- Executive summary:
In this Repeated Dose, 28-day Oral Toxicity Study performed comparable to OECD guideline 407, 12 May 1981 rMDEA-Esterquat C16-18 and C18 unsatd. (10 % a.i aqueous dispersion) was administered to groups of 25 Charles River CD rats male and female by oral gavage at dose levels of 1, 10 and 500 mg/kg bw/day for 28 days. Two other control groups received either deionised water or to pH 2.5 adjusted (HCL) deionised water (vehicle).
All animals survived to study termination. No test substance-related findings were detected or observed in clinical examinations, body weights, food consumption values, opthalmoscopic examinations, haematology, clinical biochemistry or clinical pathology evaluations including organ weights of ovary and testis and histopathology of reproductive organs (gonads, mammary gland (femals only), prostate and seminal vesicle, uterus and vagina).
The no effect level (NOEL) for this study is the high dose level of 500 mg/kg bw/day of the test article.
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