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Toxicological information

Toxicity to reproduction

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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:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent

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.