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Description of key information

In an enhanced OECD guideline 422 study that was performed in compliance with GLP the NOAEL for general, systemic toxicity of the test substance was determined to be 1000 mg/kg body weight/day for the F0 parental animals, the highest dose tested. The NOEL (no observed effect level) is 10 mg/kg bw/d for the F0 parental rats based on treatment-related, local and non-adverse effects such as sinus histiocytosis in the mesenteric lymph nodes at 300 and 1000 mg/kg bw/d and granulomatous inflammation of one lung lobe with no corroborative clinical or pathological findings indicative of systemic toxicity at 100, 300 and 1000 mg/kg bw/d. (BASF SE, 2010).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral:

In an enhanced OECD 422 GLP guideline study Kerocom F 100 was administered orally via gavage to groups of 25 male and 25 female Wistar rats (F0 animals) at doses of 10, 100, 300 and 1000 mg/kg body weight/day (BASF SE, 2010). Control animals were dosed daily with the vehicle (Olive oil Ph. Eur./DAB). The duration of treatment covered a 2-week pre-mating and mating period in both sexes, approximately 1 week post-mating in males, and the entire gestation period as well as 4 days of lactation in females.

The following test substance-related adverse effects/findings were noted in F0 parental animals of test group 4 (1000 mg/kg bw/d): Minimal to slight sinus histiocytosis in the mesenteric lymph nodes of 13 males and minimal to severe sinus histiocytosis in the mesenteric lymph nodes of all females, minimal to moderate granulomatous inflammation in the lungs of 10 males.

The following test substance-related adverse effects/findings were noted in F0 parental animals of test group 3 (300 mg/kg bw/d): Minimal to moderate sinus histiocytosis in the mesenteric lymph nodes of 12 females, minimal to slight granulomatous inflammation in the lungs of 3 males.

The following test substance-related adverse effects/findings were noted in F0 parental animals of test group 2 (100 mg/kg bw/d):

Minimal granulomatous inflammation in the lung of 1 male.

No test substance-related adverse findings were noted in F0 parental animals of test group 1 (10 mg/kg bw/d).

In conclusion, the NOAEL for general, systemic toxicity of the test substance is 1000 mg/kg body weight/day for the F0 parental animals, the highest dose tested. The NOEL (no observed effect level) is 10 mg/kg bw/d for the F0 parental rats based on treatment-related, local and non-adverse effects such as sinus histiocytosis in the mesenteric lymph nodes at 300 and 1000 mg/kg bw/d and granulomatous inflammation of one lung lobe with no corroborative clinical or pathological findings indicative of systemic toxicity at 100, 300 and 1000 mg/kg bw/d.

Dermal:

There are no data available concerning repeated dose toxicity by dermal application of the substance.

Inhalation:

There are no data available concerning repeated dose toxicity by inhalation of the substance.

Justification for classification or non-classification

GHS classification according to Annex I 1272/2008 CLP (EU GHS):

Conclusive, but not sufficient for classification.