Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene 

Endpoint summary

Description of key information

The substance cardanol is not expected to show acute toxicity effect by the oral, inhalation and dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

K1 level data obtained from experimental results.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

K1 level data obtained from experimental results.

Additional information

Acute oral-

Acute Oral Toxicity was studied ofReaction mass of Cardanol diene and Cardanol monoene and Cardanol triene (CAS No. – 37330-39-5) in Rats.

Three rats of the first group G1 were dosed with starting dose of 300 mg/kg body weight and the animals did not show any mortality. So another three animals of the same group G1 were dosed with 300 mg/kg body weight and no mortality was observed. Next, three animals of group G2 were dosed with 2000 mg/kg body weight and no mortality was observed.

Under the conditions of this; and based on the examinations performed, acute oral toxicity study ofReaction mass of Cardanol diene and Cardanol monoene and Cardanol triene (CAS No. – 37330-39-5)in female rats is as given below:

The acute oral LD₅₀(Cut-off value) of Cardanol (CAS No. – 37330-39-5) was5000 mg/kgbody weight.

Acute Inhalation

This end point was considered for waiver considering that the vapour pressure of Cardanol is very low i.e. 0.0000195 Pascal. Thus, the inhalation route is the least likely route of exposure for test substance. Thus, acute oral toxicity by the inhaltion route shall be all the more rare and hence this end point was considered for waiver.

Acute Dermal:

Acute Dermal Toxicity Study of“Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene (CAS No. – 37330-39-5)”in Wistar Rats This study was performed as per OECD No. 402.

Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Ratsfree from injury and irritation of skin were selected for the study. .

At 2000 mg/kg, all the animals were observed normal at 1, 2, 3 and 4 hours post dosing. Animal nos. 1, 4, 7, 8 and 9 were observed with erythema on day 1 and scale formation from day 2 to 8 followed by normal clinical sign till day 14. Animal nos. 5 and 6 were observed with erythema on day 1 and scale formation from day 1 to 6 followed by normal clinical sign till day 14. Animal nos. 2, 3 and 10 were observed with erythema on day 1 and scale formation from day 2 to 7 followed by normal clinical sign till day 14.

The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

The acute dermal median lethal dose of“Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene (CAS No. – 37330-39-5)”was> 2000 mg/kgbody weight.thus based on above results we can conclude that the test substance Cardanol does not exhibit the acute toxcity (Dermal route) as per CLP criteria set by EU.

Justification for selection of acute toxicity – oral endpoint
The acute oral LD50 (Cut-off value) of CAS No. – 37330-39-5 was 5000 mg/kg body weight.

Justification for selection of acute toxicity – inhalation endpoint
This end point was considered for waiver considering that the vapour pressure of Cardanol is very low i.e. 0.0000195 Pascal. Thus the inhalation route is the least likely route of exposure for test substance. Thus, acute oral toxicity by the inhaltion route shall be all the more rare and hence this end point was considered for waiver

Justification for selection of acute toxicity – dermal endpoint
The acute dermal median lethal dose of “Cardanol (CAS No. – 37330-39-5)” was > 2000 mg/kg body weight.

Justification for classification or non-classification

Based upon the studies reviewed it can be concluded that, the cardanol is not expected to show acute toxicity effect by the oral, inhalation and dermal route and thus will not be considered for further classification.