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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: 28 - day subacute oral toxicity study
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2004-07-19 to 2004-11-01
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:
2005
Report Date:
2005

Materials and methods

Principles of method if other than guideline:
OECD Guideline 407 (repeated dose 28-Day Oral Toxicity in Rodents) 1995
GLP compliance:
yes (incl. certificate)
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl: CD
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: hydroxypropylmethylcellulose
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
28 days of exposure and a 2-week recovery period
Frequency of treatment:
once daily (7 days per week) for 28 days
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
100 mg/kh bw/d
Basis:
actual ingested
Remarks:
Doses / Concentrations:
300 mg/kg bw/d
Basis:
actual ingested
Remarks:
Doses / Concentrations:
1000 mg/kg bw/d
Basis:
actual ingested
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Other effects:
no effects observed

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: see 'Remark'
Remarks on result:
other: Generation not specified (migrated information)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
There were no test item-related changes observed for any parameter tested, therefore under test conditions the NOAEL was determined to be
1000 mg/kg bw/day for the partially unsaturated TEA-Esterquat in this 4- week subchronic toxicity study.
Executive summary:

In a subchronic toxicity study according to OECD guideline 407 (1995) and EU method B7 (1996) the test substance partially unsaturated TEA-Esterquat, was administered to 5 CD rats/sex/dose by gavage at dose levels of 0,100, 300 and 1000 mg/kg bw/day for 28 days. A satellite group of 5 males and 5 female for the control and high dose group was included to assess the reversibility of any effects after a 2-week recovery period.

                                                                           

No mortality and no influence on behavior, external appearance, body weight, food and drinking water consumption, the eyes or optic region, the haematological and clinical-biochemical parameter and the relative or absolute organ weights at any of the tested dose levels was noted. No test item-related changes were revealed during neuropharmacological functional observations in any of the dosed groups.

Macroscopic post mortem examination and histopathology including the reproductive organs (epididymis, ovary, prostate, testicle and uterus) revealed no test item related changes in the partially unsaturated TEA-Esterquat treated animals.

There is no evidence for a specific target organ toxicity in this study.

Under test conditions, the NOAEL was above 1000 mg/kg bw /day in this 4- week subchronic toxicity study.

The analytical verification of dosing solutions demonstrated agreement of actual initial concentrations with nominal test concentrations.