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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
260.9 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
K2 level publication
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Based on the various studies available with Klimish rating 2 for the read across substances for CAS: 37330-39-5 based on the category approach of organic functional group along with similar mechanistic approach and having structural similarities defined by QSAR toolbox. This data is combined with the prediction done using the QSAR toolbox for the target chemical based on similar category approach, the results is summarized as follows:

Sr. No

End point

Value

Species

Route

Effects

Remarks

1.

NOAEL

261 mg/kg bw/day

Rat

Oral

No adverse effects observed.

Predicted data QSAR

2.

LOAEL

125 mg/kg bw/day

Rat

Oral

some evidence of maternal toxiclty was observed

Study report RA-27193-86-8

3.

NOAEL

 

LOAEL

 

 

NOAEL

 

LOAEL

25 mg/kg bw/day.

 

 

50 mg/kg bw/day.

 

50 mg/kg bw/day.

100 mg/kg bw/day

Mouse

Oral

-No effects reproductive organ weight, sperm motility and count,spermatozoa morphology..

-significant increase in the mean weight of caudae epididymis and prostate..

-no change in the dead implants per pregnant female mice.

-decrease the rate of pregnancy and cause embryonic losses implantation.

 

Publication data



Short description of key information:
The NOAEL (no adverse effect level) of Cardanol in rats was observed at a dose level of 260.90mg/kg bw/day.

Justification for selection of Effect on fertility via oral route:
The NOAEL (no adverse effect level) of Cardanol in rats was observed at a dose level of 260.90mg/kg bw/day.

Effects on developmental toxicity

Description of key information
The NOAEL (no adverse effect level) of Cardanol in rats was observed at a dose level of 337.65mg/kg bw/day.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
337.65 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
K2 level data predicted using QSAR toolbox.
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

Based on the various studies available with Klimish rating 2 for the read across substances for CAS: 37330-39-5 based on the category approach of organic functional group along with similar mechanistic approach and having structural similarities defined by QSAR toolbox. This data is combined with the prediction done using the QSAR toolbox for the target chemical based on similar category approach, the results is summarized as follows

Sr. No

End point

Value

Species

Route

Effects

Remarks

1.

NOAEL (Developmental toxicity)

337.666656494 mg/kg bw/day

Rat

Oral

No adverse effects observed.

Predicted data QSAR

2.

NOAEL(Fetotoxicity)

500 mg/kg bw/day

Rat

Oral

There was no evidence of fetotoxicity

Study report RA-27193-86-8

3.

NOAEL-Maternal toxicity-Female

LOAEL- Maternal toxicity -Female

50 mg/kg bw/day.

 

100 mg/kg bw/day.

Mouse

Oral

-No change in the dead implants per pregnant female mice.

-decrease the rate of pregnancy and cause embryonic losses implantation.

Publication RA 8007-24-7

 

Based on the studies summarized in the above table with various routes it can be observed that NOAEL values varies from 50 - 500 mg/Kg bw/ d. The no effects observed/effects observed on the these doses was listed as follows

-Overall effects-no adverse effects observed on body weight,food consumption etc.

-No evidence of fetotoxicity observed.

-decrease the rate of pregnancy and cause embryonic losses implantation.

Thus based on above discussion it can be concluded that substance CAS: 37330-39-5 is expected to show the similar toxicological effect based on the effects observed on the other category members. Since the no effective dose values (NOAEL) of target and readacross is in the range50 - 500 mg/Kg bw/ dthus based on this value it can be concluded that substance CAS: 37330-39-5 is considered to be not toxic to maternal toxicity as well as developmental effects below the above mentioned doses.The LOAEL value of readacross is a conservative value falling within the range. Moreover there are no known evidence of adverse effect on reproduction to Human of CAS: 37330-39-5 as well as estrogen receptor binding affinity does not indicates any mechanistic trigger based on absence of complex noncyclic structure that would raise concern of developmental toxicity.


Justification for selection of Effect on developmental toxicity: via oral route:
The NOAEL (no advesrse effect level) of Cardanol in rats was observed at a dose level of 337.65mg/kg bw/day.

Justification for classification or non-classification

The chemical Cardanol does not exhibit toxicity to the reproductive system as well as developmental toxicity within the doses mentioned in the various end points.