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EC number: 257-827-7 | CAS number: 52301-70-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
NOAEL for fertility = 250 mg/kg bw/day (based on the OECD 422 study on OB 3a -DSA)
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The substance under registration OB 2-DSA belongs to the category of Stilbene Fluorescent Whitening Agents. The reproductive toxicological potential was firstly assessed throughCombined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening (OECD 422) carried out on the substance under registration.Details on the Read Across approach for category are reported in a document attached in IUCLID section 13.
Repeated oral administration at doses of 150, 300 and 600 mg/kg bw/day to rats by gavage did not cause the death of animals. Test item treatment did not produce clinical changes in health status of animals, did not affect the normal growth of males and females.
The test item administration did not affect male ability to produce sperm that can fertilise eggs and ability of females to become pregnant.
No adverse effect of the test item treatment was observed during examination of thyroxine and rat thyroid stimulating hormone blood concentration in males. Decreased concentration of T4 hormone in males at the dose level 150 mg/kg/day was considered toxicologically insignificant.
The body weight of parental males and females was not significantly affected by the test item application.
Evaluation of the absolute and relative weight of reproductive organs of male and female, as well as the weight of pituitary and thyroid gland revealed only sporadic findings. The absolute weight of testes and epididymis was significantly decreased in males at the dose level 600 mg/kg/day (also reduced absolute weight of testes was noted in males at the dose level 150 mg/kg/day). Evaluation of relative weight of reproductive organs in males, absolute and relative weights of reproductive organs in treated females did not reveal any statistically significant differences compared to control.
Histological examination did not reveal negative effect of the test item on collected reproductive organs, pituitary and thyroid glands.
Spermatogenesis in the testes of the high dose administered males was without any pathological findings. Epididymides of both control and high dose males were without any pathological findings. Sporadic findings were of spontaneous origin.
Examination of sperm motility and morphology in treated parental males did not show any differences in comparison with the control males.
The number of implantations was comparable between treated and control groups.
The calculated parameters (mating and fertility indexes) were similar in all treated groups in comparison with the control groups. Fertility indexes were slightly lower in high dosed groups in comparison with the control group due to one non-pregnant female. Gestation indexes in treated groups were identical with the control group. The viability index was the best in the highest dosed group of females.
The test item did not affect the number of pups and their development.
The total number of pups, mean number of pups per litter and mean litter weight at first litter check after parturition and during the next intervals were similar or higher in treated groups of mothers compared to control group. The mean pup body weights at all checking intervals was slightly lower in all treated groups compared to control group due to higher number of pups per group of treated females. Macroscopical examination of pups did not show negative effect of the test item administration on development of pups.
No adverse effect of the test item treatment was observed during examination of thyroxine and rat thyroid stimulating hormone blood concentration in pups. Male nipple retention at day 13 was not recorded in any male pup. Corrected anogenital distance in treated pups was comparable to the control pups.
Based on these findings, the NOAEL value for reproduction and development was established as 600 mg/kg/day since no biologically significant changes relevant to reproduction and development were observed.
A further Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening is available on OB 3a-DSA and is used within a weight of evidence approach.
The test item was doses to 80, 250 and 750 mg/kg/bw to rats and no toxicologically adverse effects on growth of animals, food consumption and health condition of animals were detected in both sexes.
During the biometry of reproductive organs statistically significantly increased absolute and relative weight of prostate gland with seminal vesicles in males at the middle and highest dose levels was found out. During biometry of reproductive organs in females statistically significantly decreased absolute weight of ovaries was recorded. Relative weight of thyroid gland was statistically significantly increased in females in the highest dose level.
No findings related with the test item treatment were detected during the examination of microscopical structure of reproductive organs in animals at the highest dose level. In females, histopathological findings in uterus related to females’ gravidity were found out.
Examination of sperm motility and sperm morphology did not show any significant changes in males.
Concentration of hormones T4 and TSH in males from treated groups was similar with the control group. During the microscopical evaluation of thyroid gland in males there were no findings.
Concentration of hormones T4 and TSH in pups from treated groups was similar with the control group. The weight of the thyroid gland was not significantly changed in male and female pups of treated mothers in comparison with the control group of mothers.
During the microscopical evaluation of thyroid gland in pups no changes were found out.
Number of females achieving pregnancy was decreased in the middle and highest dose levels. Stillborn pups were detected in one mother from the highest dose level (all litter). Effect of cannibalism of pups in female was observed in the lowest and highest doses as well as in the control group.
Male and female fertility index and was decreased in the middle and highest dose levels. The gestation index was decreased in females at the lowest and highest dose levels. The post-natal losses were not significantly changed in treated and control groups. Markedly increased post-implantation losses in females in the highest dose level were recorded.
The total number of pups was decreased in females in all treated groups, but in the highest dose level decreased total number of pups was marked and with statistical and biological significance.
The decreasing of total number of pups and increasing of post-implantation losses were marked in the highest dose level and can be considered as biologically significant.
The weight of litters was statistically significantly decreased in highest dose level at all examination intervals and in the lowest and middle dose levels at the end of lactation period. The weight of pups was not changed compared to control group. No presence of nipples in male pups was recorded and anogenital distance in treated male and female pups was not biologically significantly affected. No macroscopical findings in pups were found out during pathological examination.
Accordingly, the NOAEL for reproduction was established as 250 mg/kg body weight/day. The NOAEL was established on the based marked increased post-implantation losses and marked decreased total number of pups in females in the highest dose level. While,the NOAEL for development was established as 750 mg/kg body weight/day, indeed all changes in developmental parameters of pups observed at all dose levels were considered to be of no toxicological significance.
In conclusion, the similar substances did not show toxicological effects on the develpomental parameters, while an unclear behavior concerning the reproductive aspects was highlighted forthe disulfonated subcategory. In this respect, a conservative value was selected from the study carried out on OB 3a-DSA, according to OECD TG 422, where the NOAEL was established to be 250 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
NOAEL for developmental toxicity = 600 mg/kg bw/day (based on the OECD 422 study on OB 2-DSA)
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 600 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The substance under registration OB 2-DSA belongs to the category of Stilbene Fluorescent Whitening Agents. The investigation on developmental toxicity potential is not a standard requirement for the tonnage band registration of this substance. However, with regard to this endpoint potential was preliminary assessed through Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening (OECD 422) carried out on the substance under registration.
Repeated oral administration at doses of 150, 300 and 600 mg/kg bw/day to rats by gavage did not cause the death of animals. Test item treatment did not produce clinical changes in health status of animals, did not affect the normal growth of males and females.
The test item administration did not affect male ability to produce sperm that can fertilise eggs and ability of females to become pregnant.
No adverse effect of the test item treatment was observed during examination of thyroxine and rat thyroid stimulating hormone blood concentration in males. Decreased concentration of T4 hormone in males at the dose level 150 mg/kg/day was considered toxicologically insignificant.
The body weight of parental males and females was not significantly affected by the test item application.
Evaluation of the absolute and relative weight of reproductive organs of male and female, as well as the weight of pituitary and thyroid gland revealed only sporadic findings. The absolute weight of testes and epididymis was significantly decreased in males at the dose level 600 mg/kg/day (also reduced absolute weight of testes was noted in males at the dose level 150 mg/kg/day). Evaluation of relative weight of reproductive organs in males, absolute and relative weights of reproductive organs in treated females did not reveal any statistically significant differences compared to control.
Histological examination did not reveal negative effect of the test item on collected reproductive organs, pituitary and thyroid glands.
Spermatogenesis in the testes of the high dose administered males was without any pathological findings. Epididymides of both control and high dose males were without any pathological findings. Sporadic findings were of spontaneous origin.
Examination of sperm motility and morphology in treated parental males did not show any differences in comparison with the control males.
The number of implantations was comparable between treated and control groups.
The calculated parameters (mating and fertility indexes) were similar in all treated groups in comparison with the control groups. Fertility indexes were slightly lower in high dosed groups in comparison with the control group due to one non-pregnant female. Gestation indexes in treated groups were identical with the control group. The viability index was the best in the highest dosed group of females.
The test item did not affect the number of pups and their development.
The total number of pups, mean number of pups per litter and mean litter weight at first litter check after parturition and during the next intervals were similar or higher in treated groups of mothers compared to control group. The mean pup body weights at all checking intervals was slightly lower in all treated groups compared to control group due to higher number of pups per group of treated females. Macroscopical examination of pups did not show negative effect of the test item administration on development of pups.
No adverse effect of the test item treatment was observed during examination of thyroxine and rat thyroid stimulating hormone blood concentration in pups. Male nipple retention at day 13 was not recorded in any male pup. Corrected anogenital distance in treated pups was comparable to the control pups.
Based on these findings, the NOAEL value for reproduction and development was established as 600 mg/kg/day since no biologically significant changes relevant to reproduction and development were observed.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.7 Reproductive toxicity section, reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring.
The available experimental data are adequate for classification and labelling and the substance is not classified for reproductive and developmental toxicity according to the CLP Regulation (EC 1272/2008).
Additional information
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