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EC number: 276-684-1 | CAS number: 72480-09-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
NOAEL fertility (rat): 70 mg/Kg bw
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 70 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 Similar substance 02 was tested for reproduction and subacute toxicity using the OECD Test Guideline No. 422: Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test, Adopted by the Council on March 22nd 1996.
The administration had not adverse effect on mortality, parameters of functional observation and some reproduction parameters - course of mating and lactation, spermiogenesis, macroscopical and microscopical structure of reproductive organs and pituitary gland of parental animals and number of post-natal losses of mothers.
The test substance during Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test caused changes in clinical status (excrement and tail were coloured by the test substance), haematological parameters (primarily on the red blood cells - decreased value of total erythrocyte count, haematocrit and haemoglobin, increased value of mean corpuscular volume), biochemical parameters (primarily increased value of sodium ions, phosphorus, bilirubin, total protein and creatinine, decreased value of potassium ions), biometry of organs (changes weight of spleen, kidneys, heart and brain weight) and urine parameters (urine volume, colour, specific weight, occurrence of leucocytes, protein and ketones) at the highest dose level.
The test substance had influence on macroscopical and microscopical structure of some organs and tissues (occurrence of pigment in kidneys, rectum, intestines and stomach, reversible increased occurrence of ulcer or erosion in large intestines and rectum, extramedular haemopoiesis and hemosiderin in spleen and liver, hyaline droplets in kidneys).
The test substance treatment affected the number of pups (decrease of the total number of live pups and mean weight of litters and affected pups, pre-implantation losses (decreased number of corpora lutea, uterus implantations and pups).
The highest incidence of statistically or biologically significant effects was recorded at the middle and highest dose level while most of changes which were found at the lowest dose level had only mild intensity without adverse alteration of animal organism.
Based on the Read across principle(read-across from supporting substance -structural analogue or surrogate), the result can be considered for the repeated dose toxicity assessment of the substance. Justification for Read Across is detailed in the report attached to the IUCLID section 13.
The value of NOAEL fertility (oral) was established as 70 mg/kg body weight/day both for males and females. This value was established on the basis of haematology parameters (mainly - decreased value of total erythrocyte count, haematocrit and haemoglobin, increased value of mean corpuscular volume) and biochemistry findings (mainly - increased value of sodium ions, phosphorus, bilirubin, total protein and creatinine, decreased value of potassium ions). Histopathological evaluation revealed specific target organ toxicity effect on the spleen, kidneys and intestines.
Effects on developmental toxicity
Description of key information
NOAEL developmental (rat): 70 mg/Kg bw
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 70 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 study on reproduction is also considered as a screening for developmental parameters. No further animal studies are considered based on the overall toxicological profile of the substance and the related use and exposure scenario.
The NOAEL (No Observed Adverse Effect Level) for development was established as 70 mg/kg body weight/day. The values were established on the basis of decrease of the total number of live pups and mean weight of litters, decreased of pre-implantation losses and fertility parameters (decreased number of corpora lutea and uterus implantations). Other effects were recorded such as changed colour of milk, flatulence, stomach without milk. These modulations though observed in pups are secondary effects displayed on offspring after exposure of pregnant mice.
Toxicity to reproduction: other studies
Description of key information
NOAEL reproduction (rat): 70 mg/Kg bw
Additional information
The Similar substance 02 was tested for reproduction and subacute toxicity using the OECD Test Guideline No. 422: Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test, Adopted by the Council on March 22nd 1996.
The administration had not adverse effect on mortality, parameters of functional observation and some reproduction parameters - course of mating and lactation, spermiogenesis, macroscopical and microscopical structure of reproductive organs and pituitary gland of parental animals and number of post-natal losses of mothers.
The test substance during Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test caused changes in clinical status (excrement and tail were coloured by the test substance), haematological parameters (primarily on the red blood cells - decreased value of total erythrocyte count, haematocrit and haemoglobin, increased value of mean corpuscular volume), biochemical parameters (primarily increased value of sodium ions, phosphorus, bilirubin, total protein and creatinine, decreased value of potassium ions), biometry of organs (changes weight of spleen, kidneys, heart and brain weight) and urine parameters (urine volume, colour, specific weight, occurrence of leucocytes, protein and ketones) at the highest dose level.
The test substance had influence on macroscopical and microscopical structure of some organs and tissues (occurrence of pigment in kidneys, rectum, intestines and stomach, reversible increased occurrence of ulcer or erosion in large intestines and rectum, extramedular haemopoiesis and hemosiderin in spleen and liver, hyaline droplets in kidneys).
The test substance treatment affected the number of pups (decrease of the total number of live pups and mean weight of litters and affected pups, pre-implantation losses (decreased number of corpora lutea, uterus implantations and pups).
The highest incidence of statistically or biologically significant effects was recorded at the middle and highest dose level while most of changes which were found at the lowest dose level had only mild intensity without adverse alteration of animal organism.
Based on the read-across principle, the result can be considered for the reproductive toxicity assessment of the substance. Justification for read- across is detailed in the report attached to the IUCLID section 13.
The NOAEL for reproduction for males and females was established as 70 mg/kg body weight/day. The value is based on the effect in females: decrease of the total number of live pups and mean weight of litters, decreased of pre-implantation losses and fertility parameters (decreased number of corpora lutea and uterus implantations). In males no effect on reproduction was observed.
Justification for classification or non-classification
The test substance administration had not adverse effect on mortality, parameters of functional observation and some reproduction parameters - course of mating and lactation, spermiogenesis, macroscopical and microscopical structure of reproductive organs and pituitary gland of parental animals and number of post-natal losses of mothers.
Slight changes of body weight and body weight increment in males and females, clinical status of animals, haematological and biochemical blood parameters in males, biometry of organs (spleen) in males and females, macroscopical and microscopical structure of organs in males were detected even at the dose level 70 mg/kg/day. However, these modulations were considered incidental, without toxicological relevance and no classification for reproductive toxicity is warranted for the Similar Substance 02.
Based on the read-across principle, the result can be considered for the reproduction toxicity assessment of the registered substance. Justification for read-across is detailed in the report attached to the IUCLID section 13.
As conclusion the registered substance is not classified for the reproduction toxicity, according to CLP Regulation 1272/2008.
Additional information
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