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Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
two-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.3800 (Reproduction and Fertility Effects)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Pyridine-2-thiol 1-oxide, sodium salt
EC Number:
223-296-5
EC Name:
Pyridine-2-thiol 1-oxide, sodium salt
Cas Number:
3811-73-2
Details on test material:
- Analytical purity: 40.8%
- Lot/batch No.: 99072150

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Nossan Srl
- Age at study initiation: 5-6 weeks
- Weight at study initiation: male 19.3g female 15.1g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on mating procedure:
Pairing for 2 weeks then change of animals within the treatment group.
Duration of treatment / exposure:
-Parents 10 weeks before mating and thereafter through the day prior to sacrifice
-F1 from the day after selection (nominal day 22)
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 0.7, 1.4, 2.8 mg/kg bw
Basis:

No. of animals per sex per dose:
24

Examinations

Parental animals: Observations and examinations:
-CLinical signs
-Body weight
-Food consumption
Oestrous cyclicity (parental animals):
-Parent and F1 from 2 weeks prior to paring until mating
Sperm parameters (parental animals):
-Sperm viability and motility
-Testicular resistant sperm heads
-Testis weight
-Epididymus weight
Litter observations:
-Number and sex of pups
-Still births
-Live births
-Presence of gross anomalies
-Weight gain
-Vaginal opening
-Balano preputial separation
-Testes descent
Postmortem examinations (parental animals):
-Organ weights: adrenal glands, brain, testes, kidneys, liver, ovaries, pituitary, spleen, uterus, epididymides (total and cauda), seminal vesicles, prostate
-Histopathology: vagina, uterus, ovaries, testis, epididymis, seminal vesicle, prostate, coagulating gland, pituitary, adrenals, abnormalities

Postmortem examinations (offspring):
- F1 Organ weights: adrenal glands, brain, testes, kidneys, liver, ovaries, pituitary, spleen, uterus, epididymides (total and cauda), seminal vesicles, prostate
- F1 Histopathology: vagina, uterus, ovaries, testis, epididymis, seminal vesicle, prostate, coagulating gland, pituitary, adrenals, abnormalities

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

-Parent male: Lower body weight in high dose males, compared to the control. Lower food consumption in high dose males, compared to the control. Lower terminal body weight in high dose animals. No differences in sperm analysis.
-Parent female: Emaciation in high dose females. Lower body weight in high dose females, compared to the control. Lower food consumption in high dose females, compared to the control. Lower terminal body weight in high dose animals. Lower kidney weights in mid and high dose females. Higher uterus weight in mid and high dose females. No relevant macroscopic or microscopic post-mortem findings.
-F1 male: Slightly later prepuzial serparation in high dose animals. Lower body weight in high dose males, compared to the control. Lower terminal body weight in high dose animals. No differences in sperm analysis.
-F1 female: Emaciation in high dose females. Lower body weight in high dose females, compared to the control. Lower food consumption in high dose females, compared to the control. Lower terminal body weight in high dose animals. Higher spleen weight in females and lower epididymes weight in males of the high dose group. No relevant macroscopic or microscopic post-mortem findings
-F2: Lower mean pup weight and litter weight in mid or/and high dose groups before/at weaning. Increase in pup loss in mid dose animals on Day 4 post partum. Pups with testis not descended in mid and high dose groups.



Effect levels (P0)

open allclose all
Dose descriptor:
LOAEL
Effect level:
2.8 mg/kg bw/day (nominal)
Sex:
male
Dose descriptor:
LOAEL
Effect level:
1.4 mg/kg bw/day (nominal)
Sex:
female
Dose descriptor:
NOAEL
Effect level:
1.4 mg/kg bw/day (nominal)
Sex:
male
Dose descriptor:
NOAEL
Effect level:
0.7 mg/kg bw/day (nominal)
Sex:
female

Results: F1 generation

Effect levels (F1)

open allclose all
Dose descriptor:
LOAEL
Generation:
F1
Effect level:
2.8 mg/kg bw/day (nominal)
Sex:
male
Dose descriptor:
LOAEL
Generation:
F1
Effect level:
1.4 mg/kg bw/day (nominal)
Sex:
female
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1.4 mg/kg bw/day (nominal)
Sex:
male
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
0.7 mg/kg bw/day (nominal)
Sex:
female

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Various toxic signs, such as lower body weight, lower food consumption, emaciation in females, lower pup weight, later descending of testis, later prepuzial separation were observed in the high dose group (2.8 mg as /kg bw) and in a few cases also in the mid dose group (1.4 mg as /kg bw). This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under Regulation EC 1907/2006.