Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
150 mg/kg bw/day
Study duration:
subacute
Species:
rat
Additional information

A study according to OECD 422 guideline and GLP was conducted (BASF SE, 2015) to provide data on the possible effects of the test item Octadecanoic acid, sulfo-, potassium salt on systemic and local toxicity and on reproductive performance of Wistar rats and the development of pups following daily oral administration of the test item via gavage. Concentrations of 0, 50, 150 and 500 mg/kg were given to male and female rats during a premating period of 2 weeks and during mating (1 week), up to a total of approximately 4 weeks for males and including gestation and lactation until postnatal day 4 (PN day 4) for females (up to a total of approximately 6 weeks). The substance was homogeneously distributed in the gavage liquids. The following test substance-related adverse effects/findings were noted:

Test group 3: 500 mg/kg bw/d octadecanoic acid, sulfo-, potassium salt

F0 PARENTAL ANIMALS CLINICAL EXAMINATIONS

• decreased food consumption during premating (up to -9%), gestation (up to -20%), and lactation (not statistically significant -10%) in females

• decreased body weight during lactation (up to -10%)

• piloerection shown by 3 females during lactation

REPRODUCTIVE PERFORMANCE

• no test substance-related adverse findings

CLINICAL PATHOLOGY

• no test substance-related adverse findings

PATHOLOGY

• no test substance-related adverse findings

F1 PUPS CLINICAL EXAMINATIONS/ GROSS FINDINGS

• decreased live birth index (64.2%)

• increase number of stillborn pups (35.8%) leading to 88.9% dams with stillborn pups

• increased perinatal loss (36.7%)

• decreased viability index (73%)

• increased number of pups found dead (4 pups)

• increased number of pups missing (cannibalized, 13 pups)

• decreased pup weights of both sexes at postnatal day 1 (-23.0%)

• decreased pup weight change between postnatal day 1 and 4 in pups of both sexes (-28.5%) were bases on a decreased pup weight change in male pups of -25.4%, and in female pups of -24.1% (not statistically significant)

• increased number of runts (10 males and 12 females)

• increased number of pups with post mortem autolyzes

• increased number of pups with discolored liver

• increased number of pups with empty stomach For the other dose groups (50 and 150 mg/kg) no effects were observed.

Under the conditions of this Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, the oral administration by gavage of octadecanoic acid, sulfo-, potassium salt to Wistar rats revealed no signs of general systemic toxicity in male parental animals up to 500 mg/kg bw/d. Signs of systemic toxicity were observed in female parental animals at 500 mg/kg bw/d. Thus, the no observed adverse effect level (NOAEL) for general systemic toxicity was 500 mg/kg bw/d in male parental animals and 150 mg/kg bw/d in female parental animals. The no observed adverse effect level (NOAEL) for reproductive performance and fertility was 500 mg/kg bw/d in male and female Wistar rats. The NOAEL for developmental toxicity in the F1 progeny was 150 mg/kg bw/d.



Short description of key information:
OECD 422 (rat, oral, GLP, BASF SE, 2015): NOAEL = 150mg/kg bw/day

Effects on developmental toxicity

Description of key information
OECD 422 (rat, oral, GLP, BASF SE, 2015): NOAEL = 150mg/kg bw/day 
Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
150 mg/kg bw/day
Study duration:
subacute
Species:
rat
Additional information

A study according to OECD 422 guideline and GLP was conducted (BASF SE, 2015) to provide data on the possible effects of the test item Octadecanoic acid, sulfo-, potassium salt on systemic and local toxicity and on reproductive performance ofWistarrats and the development of pups following daily oral administration of the test item via gavage. Concentrations of 0, 50, 150 and 500 mg/kg were given to male and female rats during a premating period of 2 weeks and during mating (1 week), up to a total of approximately 4 weeks for males and including gestation and lactation until postnatal day 4 (PN day 4) for females (up to a total of approximately 6 weeks). The substance was homogeneously distributed in the gavage liquids.The following test substance-related adverse effects/findings were noted:

Test group 3: 500 mg/kg bw/d octadecanoic acid, sulfo-, potassium salt

F0 PARENTAL ANIMALS CLINICAL EXAMINATIONS

• decreased food consumption during premating (up to -9%), gestation (up to -20%), and lactation (not statistically significant -10%) in females

• decreased body weight during lactation (up to -10%)

• piloerection shown by 3 females during lactation

REPRODUCTIVE PERFORMANCE

• no test substance-related adverse findings

CLINICAL PATHOLOGY

• no test substance-related adverse findings

PATHOLOGY

• no test substance-related adverse findings

F1 PUPS CLINICAL EXAMINATIONS/ GROSS FINDINGS

• decreased live birth index (64.2%)

• increase number of stillborn pups (35.8%) leading to 88.9% dams with stillborn pups

• increased perinatal loss (36.7%)

• decreased viability index (73%)

• increased number of pups found dead (4 pups)

• increased number of pups missing (cannibalized, 13 pups)

• decreased pup weights of both sexes at postnatal day 1 (-23.0%)

• decreased pup weight change between postnatal day 1 and 4 in pups of both sexes (-28.5%) were bases on a decreased pup weight change in male pups of -25.4%, and in female pups of -24.1% (not statistically significant)

• increased number of runts (10 males and 12 females)

• increased number of pups with post mortem autolyzes

• increased number of pups with discolored liver

• increased number of pups with empty stomach For the other dose groups (50 and 150 mg/kg) no effects were observed.

Under the conditions of this Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, the oral administration by gavage of octadecanoic acid, sulfo-, potassium salt to Wistar rats revealed no signs of general systemic toxicity in male parental animals up to 500 mg/kg bw/d. Signs of systemic toxicity were observed in female parental animals at 500 mg/kg bw/d. Thus, the no observed adverse effect level (NOAEL) for general systemic toxicity was 500 mg/kg bw/d in male parental animals and 150 mg/kg bw/d in female parental animals. The no observed adverse effect level (NOAEL) for reproductive performance and fertility was 500 mg/kg bw/d in male and female Wistar rats. The NOAEL for developmental toxicity in the F1 progeny was 150 mg/kg bw/d.

Justification for classification or non-classification

Based on the available data, the test substance shall be classified regarding developmental toxicity (cat 1B).