Registration Dossier

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test guideline (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No deficiencies.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
Deviations:
yes
Remarks:
dose administration to males only 8 weeks instead of 10 as recommended by the guideline
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
Hypochlorous acid
EC Number:
232-232-5
EC Name:
Hypochlorous acid
Cas Number:
7790-92-3
IUPAC Name:
hypochlorous acid
Details on test material:
Aqueous chlorine (HOCl)

Test animals

Species:
rat
Strain:
Long-Evans
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source: Charles River Breeding Laboratories, Portage, USA
4-6 weeks old, weight not stated

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
Total volume applied: 10 mL/kg
Details on mating procedure:
One male housed with two females throughout breeding period.
Duration of mating: 10 days
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Duration of exposure before mating
Males: 56 days; Females: 14 days

Duration of exposure in general P, F1
Males: 56 days prior to breeding and throughout the 10-day breeding period.
Females: 14 days prior to breeding and throughout breeding, gestation and lactation until pups were weaned on day 21.
Frequency of treatment:
daily
Details on study schedule:
Male were dosed 56 days prior and throuout breeding, females were dosed 14 days prior to breeding, throughout breeding, gestation and lactation until day 21 of lactation.
Doses / concentrations
Remarks:
Doses / Concentrations:
1, 2, or 5 mg/kg bw/day
Basis:
nominal conc.
No. of animals per sex per dose:
12 males, 24 females
Control animals:
yes, concurrent vehicle

Examinations

Parental animals: Observations and examinations:
Clinical signs Yes
Body weight Yes
Oestrous cyclicity (parental animals):
Not stated
Sperm parameters (parental animals):
Testis weight
Epididymides weight
Sperm motility
Sperm morphology
Sperm concentration in epididymides
Litter observations:
Number of pups
Stillbirths
Litter size
Live births
Presence of gross anomalies
Weight gain
Weight of reproductive organs
Day of eye opening
Complete blood counts
Hormone analysis
Vaginal patency
Postmortem examinations (parental animals):
Organ weights P and F1:
Female reproductive tract
Testes
Epididymides (total and cauda)
Prostate
Seminal vesicles

Histopathology P and F1
Organs of the reproductive tract
Postmortem examinations (offspring):
Organ weights P and F1:
Female reproductive tract
Testes
Epididymides (total and cauda)
Prostate
Seminal vesicles

Histopathology P and F1
Organs of the reproductive tract
Statistics:
not stated

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:
not examined
Reproductive function: sperm measures:
no effects observed
Reproductive performance:
no effects observed

Effect levels (P0)

open allclose all
Dose descriptor:
LOAEL
Effect level:
> 5 mg/kg bw/day (nominal)
Sex:
male/female
Dose descriptor:
NOAEL
Effect level:
>= 5 mg/kg bw/day (nominal)
Sex:
male/female

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:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings:
no effects observed

Effect levels (F1)

open allclose all
Dose descriptor:
LOAEL
Generation:
F1
Effect level:
> 5 mg/kg bw/day (nominal)
Sex:
male/female
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
>= 5 mg/kg bw/day (nominal)
Sex:
male/female

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
LO(A)EL
Parent males > 5.0 mg/kg bw/day
Parent females > 5.0 mg/kg bw/day
F1 males > 5.0 mg/kg bw/day
F1 females > 5.0 mg/kg bw/day

NO(A)EL
Parent males ≥ 5.0 mg/kg bw/day
Parent females ≥ 5.0 mg/kg bw/day
F1 males ≥ 5.0 mg/kg bw/day
F1 females ≥ 5.0 mg/kg bw/day
Executive summary:
No differences were observed between control rats and those rats exposed to up to 5 mg/kg bw/day of the test material when fertility, viability, litter size, day of eye opening or day of vaginal patency were evaluated. No alterations in sperm count, sperm direct progressive movement, percent motility or sperm morphology were observed among adult male rats. In addition, male and female reproductive organ weights were comparable to the control groups and no significant histopathological changes were observed among treated male female rats.

Categories Display