Octan-3-ol

Endpoint summary

Description of key information

Skin Sensitization:

3-octanol was used as test material to evaluate skin sensitization potential by human maximization test.

3-octanol 12% in petrolatum was applied on the skin of 29 human volunteers. No skin reactions were observed. Hence, 3-octanol can be considered as not skin sensitizer for human skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Qualifier:

according to guideline

Guideline:

other: Maximization test

Principles of method if other than guideline:

To evaluate skin sensitization potential of 3-octanol on 29 human volunteers

GLP compliance:

not specified

Type of study:

other: Maximization test

Justification for non-LLNA method:

not specified

Specific details on test material used for the study:

Name of the test chemical: 3-Octanol
Molecular Formula: C8H18O
Molecular Weight: 130.229 g/mole
Substance type: organic
Physical state: Liquid

Species:

other: humans

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

no data available

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

12% in petrolatum

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

12% in petrolatum

Adequacy of challenge:

not specified

No. of animals per dose:

29 human volunteers

Details on study design:

no data available

Challenge controls:

no data available

Reading:

1st reading

Group:

test chemical

Dose level:

12% in petrolatum

No. with + reactions:

0

Total no. in group:

29

Clinical observations:

no dermal reactions observed

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: not sensitizing

Conclusions:

3-octanol 12% in petrolatum when tested for skin sensitization on 29 human volunteers showed no skin reaction. Hence, 3-octanol can be considered as not skin sensitizer for human skin.

Executive summary:

3-octanol was used as test material to evaluate skin sensitization potential by human maximization test.

3-octanol 12% in petrolatum was applied on the skin of 29 human volunteers. No skin reactions were observed. Hence, 3-octanol can be considered as not skin sensitizer for human skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin Sensitization:

Various studies have been investigated for assessing the dermal sensitization potential of 3-octanol to a greater or lesser extent. The studies are based on in vivo experiments in humans along with predicted data for target chemical and its structurally similar read across chemicals, 2-ethylhexyl alcohol[CAS: 104-76-7] and Hexan-1-ol[CAS: 111-27-3].The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.

A maximization test was carried out (Food and Cosmetics Toxicology, Volume 17, Supplement, December 1979, Page 881) to assess the dermal sensitization potential of 3-octanol in humans. 3-octanol 12% in petrolatum was applied on the skin of 29 human volunteers. No skin reactions were observed. Hence, 3-octanol can be considered as not skin sensitizer for human skin.

The skin sensitization potential of Octan-3-ol was estimated by SSS (2018) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor. Octan-3-ol was predicted to be not sensitizing to the skin of male/female Hartley guinea pigs.

 

Skin sensitization effects were also estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for 3 -octanol. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, 3 -octanol was considered to be not sensitizing.

The experimental and estimated results are in agreement with each other indicating a strong possibility of 3-octanol being not sensitizing to skin.

These results are supported by the experimental study summarized in Food and Chemical Toxicology, 48, (2010), S1–S46; for the structurally similar read across chemical,2 -ethylhexyl alcohol[CAS: 104-76-7]. 2-ethylhexyl alcohol[CAS: 104-76-7] 4% in petrolatum was applied on the skin of 29 human volunteers.

No skin reactions were observed. Hence, 2-ethylhexyl alcohol[CAS: 104-76-7] can be considered as not skin sensitizer for human skin.

The above results are further supported by the experimental study summarized in Food and Cosmetics Toxicology, Volume 13, Issue 6, 1975, Pages 695-696; for the structurally similar read across chemical; Hexan-1-ol[CAS: 111-27-3]. Hexan-1-ol 1% in petrolatum was applied on the skin of 21 human volunteers.

No skin reactions were observed. Hence, hexan-1-ol can be considered as not skin sensitizer for human skin.

Based on the available data for the target as well as read across chemicals and applying the weight of evidence approach,3-octanol was not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Available data for 3-Octanol indicates that it is not likely to cause any dermal sensitization to skin.

3 -Octanol can be considered to be not sensitizer to skin and can be classified under the category “Not Classified” as per CLP regulation.