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Diss Factsheets

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: one-generation screening assay
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
110615-47-9
Cas Number:
110615-47-9
IUPAC Name:
110615-47-9
Details on test material:
- Name of test material (as cited in study report): APG, C12–C14 fatty alcohol, degree of polymerisation: 1.43
- Physical state: No data
- Analytical purity: No data
- Lot/batch No.: No data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
According to Guideline.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on mating procedure:
- M/F ratio per cage: 1
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post partum).
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
10
Control animals:
yes
Positive control:
Not required.

Examinations

Parental animals: Observations and examinations:
According to Guideline.
Oestrous cyclicity (parental animals):
According to Guideline.
Sperm parameters (parental animals):
According to Guideline.
Litter observations:
According to Guideline.
Postmortem examinations (parental animals):
According to Guideline.
Postmortem examinations (offspring):
According to Guideline.

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:
not examined

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
no effects observed
Reproductive function: sperm measures:
no effects observed
Reproductive performance:
no effects observed

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
other: No treatment-related effects.

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Sexual maturation:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings:
no effects observed

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day.

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