Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Oral:

The effects of the test substance on reproduction were investigated in a screening study according to OECD guideline 421, (BASF SE 2011). No adverse effects were observed up to the limit dose of 15000 ppm (♂: ~1271 mg/kg bw per day, ♀: ~1496 mg/kg bw per day).

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat
Quality of whole database:
GLP and guideline compliant study
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 effects of the test substance on reproduction were investigated in a screening study according to OECD guideline 421, (BASF SE, 2011) when administered orally via the diet to male and female Wistar Hannover rats. Groups of 10 males and 10 females received the test substance via the diet at fixed inclusion levels of 1500, 5000 and 15000 ppm. A similarly constituted group of animals received untreated diet and acted as a control. The achieved dose levels were approximately 123, 420 and 1271 mg/kg body weight/day for males and approximately 151, 537 and 1496 mg/kg body weight/day for females. Males were treated for 2 weeks prior to pairing and during pairing of all females until the day of necropsy, for a total of 30 or 31 days of treatment. Females were treated for 2 weeks prior to pairing, during pairing and throughout the gestation and lactation periods until day 4 post partum. 

The following investigations were performed on all groups: Ovaries, testes, epididymides and macroscopically altered tissues of F0 animals were examined histologically. Parameters of general toxicity and fertility, as well as pre- and post-natal development were recorded.

No changes in body weights, oestrus cycle, food consumption, implantation, gestation length, corpora lutea, litter data and sex ratios were seen or were considered related to treatment. Yellow staining of the fur was noted in all treated males, all females of the mid- and high dose group and in one female of the low dose group. This finding was considered related to the colour of the test item and therefore not toxicologically significant. Terminal body weight, as well as absolute and relative epididymides, testes and ovary weights were unaffected by treatment. The most relevant finding detected at macroscopic examination was generalised yellow colouration of the skin noted in all mid- and high dose males and in the majority of the high dose females. No treatment-related changes were seen at microscopic examination in the high dose males or in the high dose females (testes, epididymides and ovaries).

On the basis of the results the highest dose tested (15000 ppm) is considered the NOAEL, corresponding to 1271 mg/kg bw/day for males and 1496 mg/kg bw/day for females.


Effects on developmental toxicity

Description of key information

Oral:

The effects of the test substance development of the offspring was investigated in a screening study according to OECD guideline 421 (BASF SE, 2011). No adverse effects on the development of the offspring were observed up to the limit dose of 15000 ppm (: ~1271 mg/kg bw per day, : ~1496 mg/kg bw per day).

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
GLP and guideline compliant study report.
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 effects of the test substance on reproduction were investigated in a screening study according to OECD guideline 421, (BASF SE, 2011) when administered orally via the diet to male and female Wistar Hannover rats. Groups of 10 males and 10 females received the test substance via the diet at fixed inclusion levels of 1500, 5000 and 15000 ppm. A similarly constituted group of animals received untreated diet and acted as a control. The achieved dose levels were approximately 123, 420 and 1271 mg/kg body weight/day for males and approximately 151, 537 and 1496 mg/kg body weight/day for females. Males were treated for 2 weeks prior to pairing and during pairing of all females until the day of necropsy, for a total of 30 or 31 days of treatment. Females were treated for 2 weeks prior to pairing, during pairing and throughout the gestation and lactation periods until day 4 post partum. 

The sex ratio and mortality of F1 pups were not affected by treatment up to the highest dose of 15000 ppm. No externally malformed pups were observed.

The NOAEL for developmental toxicity in rats therefore corresponds to 1271 mg/kg bw/day (♂) or 1496 mg/kg bw/day (♀), respectively.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.

A NOAEL of > 1200 mg/kg bw/day was determined in rats. As a result the substance is not considered to be classified for reproductive or developmental toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.