2-dodecylhexadecan-1-ol

Endpoint summary

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

sub-chronic toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please see read-across justification document in Chapter 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across: supporting information

Positive control:

none

Key result

Dose descriptor:

NOEL

Effect level:

>= 1 other: mL/kg bw

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: overall effects

Critical effects observed:

not specified

Conclusions:

There was no indication that the structuryll-related substance 2-octyl dodecanol was toxic in male or female Wistar rats at the limit dose of 1 mL/kg bw. The results of this study can be cross-read to 2-dodecylhexadecan-1-ol.

Executive summary:

The structurally similar subsance 2-Octyl dodecanol was investigated in a 13 week subchronic toxicity study in male and female Wistar rats. 1 mL/kg bw of the substance was administered by gavage or the animals received olive oil as a control (vehicle).

No clinical signs or mortality was observed. There were no statistically significant differences in body weights or body weight gains between the dose and control group. Food and water consumption was not specifically recorded but was considered to be normal by observation in all groups.

There were no differences between dose and control groups in the recorded hematological parameters. All values were within the normal range for animals of this age.

There were no statistically significant differences in clinical chemistry parameters between the dose and control group. No statistically significant differences in urine parameters between the dose and control group were observed. Organ weights were in the normal range for rats of this age. There were no statistically significant differences in organ weights between dose and control groups.

No biologically relevant macroscopical findings were observed in the control or dose animals.

No biologically relevant findings were reported for the organs that were histologically investigated. All individual findings were accidental and usual for rats of this age and were found in both, control and dose animals.

There was no indication that 2-octyl dodecanol was toxic in a 13 week subchronic study with male or female Wistar rats at the limit dose of 1 mL/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

839.6 mg/kg bw/day

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

A well documented 13 week subchronic toxicity study is available for the structurally related 2-octyldodecan-1-ol (C20). Male and female rats received the sustance daily by gavage. There were no indications that 2-octyldodecan-1-ol was toxic at the limit dose of 1 ml/kg bw/d. Due to their structural similarity no effects are expected after repeated oral application of the other Guerbet alcohols of this category either.

Additional data are available for the linear C22-alcohol docosan-1-ol. In a repeated dose toxicity study conducted according to a Guideline similar to OECD Guideline 408 male and female rats received oral doses of up to 1000 mg/kg daily for 26 weeks. No effects were observed resulting in a NOEL of 1000 mg/kg bw.

Justification for classification or non-classification

Available data are conclusive but not sufficient for classfication of 2-dodecylhexadecan-1-ol

with regard to repeated dose toxicity.