Alcohols, C16-18

Endpoint summary

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:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

Magnusson and Kligman guinea pig maximization procedure.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Method: other: Magnusson and Kligman guinea pig maximization procedure.

Species:

guinea pig

Strain:

not specified

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Strain: guinea pig
- Sex: female
- Weight at study initiation: 400-500 g
- Number of animals: 20
- Controls: 20

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 44-74
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Route:

intradermal and epicutaneous

Vehicle:

other: 1st induction olive oil; 2nd induction vaseline; challenge vaseline or ethanol.

Concentration / amount:

1st: Induction 5 % intracutaneous
2nd: Induction 5 % occlusive epicutaneous
3rd: Challenge 25 % open epicutaneous

Route:

epicutaneous, occlusive

Vehicle:

other: 1st induction olive oil; 2nd induction vaseline; challenge vaseline or ethanol.

Concentration / amount:

1st: Induction 5 % intracutaneous
2nd: Induction 5 % occlusive epicutaneous
3rd: Challenge 25 % open epicutaneous

No. of animals per dose:

40

Details on study design:

ADMINISTRATION/EXPOSURE
- Study type: M&K maximization
- Preparation of test substance for induction: 5% intracutaneous in olive oil.
- Preparation of test substance for induction: 5% topical in vaseline.
- Concentrations used for induction: 25% topical in vaseline
- Concentration in Freuds Complete Adjuvant (FCA): 1:1
- Positive control: Not reported

Challenge controls:

10 non-induced animals received challenge applications.

Positive control substance(s):

not specified

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5 and 25% (challenge)

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

no effects

Remarks on result:

no indication of skin sensitisation

Remarks:

Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 and 25% (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

5 and 25% (challenge)

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no effects

Remarks on result:

no indication of skin sensitisation

Remarks:

Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 and 25% (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

5 and 25% (challenge)

No. with + reactions:

0

Total no. in group:

29

Clinical observations:

no effects

Remarks on result:

no indication of skin sensitisation

Reading:

2nd reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5 and 25% (challenge)

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

no effects

Remarks on result:

no indication of skin sensitisation

Remarks:

Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 and 25% (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

5 and 25% (challenge)

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no effects

Remarks on result:

no indication of skin sensitisation

Remarks:

Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 and 25% (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.

RESULTS OF TEST

- Sensitization reaction: Response 0/20 test, 0/20 control

- Clinical signs: None

- Rechallenge: Not required

Interpretation of results:

other: not sensitising

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In a reliable study, Alcohols, C16-18 was not a skin sensitiser in guinea pigs.

Executive summary:

Alcohols, C16-18 is not a skin sensitiser in the guinea pig when tested using the Magnusson and Kligman maximisation assay.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitisation

No evidence of sensitisation in the study of Gloxhuber, Ch..1983.The test substance Alcohols, C16-18 is not sensitising to skin.

 Alcohols, C16-18 is not a skin sensitiser in the guinea pig when tested using the Magnusson and Kligman maximisation assay.

   

 Synopsis

Not sensitising

 

 In other study of Driscoll, R. 1996 the test substance (hexadecan-1-ol(as a read across)) is not sensitizing to skin.

In a reliable study, conducted according to OECD guideline 406,hexadecan-1-olwas not a skin sensitiser in guinea pigs.

 

 This result can be reliably be read across to the substance Alcohols, C16-18(CAS# 67762-27-0)

 

Synopsis

Not sensitising

  

Conclusion

Aliphatic alcohols do not have a skin sensitisation potential in animals. Based on human evidence, the allergenic potency of this category is very low.

 

 

Migrated from Short description of key information:
No evidence of skin sensitisation. It is concluded that the substance Alcohols, C16-18 does not meet the criteria to be classified for human health hazards for Inhalation - local effect: skin sensitisation.

Respiratory sensitisation

Link to relevant study records

Reference

Endpoint:

respiratory sensitisation: in vivo

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Respiratory sensitisation.

There are no Respiratory sensitisation studies available.

Due to the absence of chemical groups or other structural alerts this substance is not considered to exhibit an high hazard potential.

Alcohols, C16-18 is of low priority for further work based on a low hazard potential is of low priority for further work based on a low hazard potential.

There is no information available from single or repeated inhalation exposures in laboratory animals or from human experience allowing a conclusion on potential respiratory tract irritation and sensitisation of the aliphatic alcohols.

Therefore testing for Respiratory sensitisation does not need to be performed.

Migrated from Short description of key information:
There are no Respiratory sensitisation studies available.
Due to the absence of chemical groups or other structural alerts this substance is not considered to exhibit an high hazard potential.
Alcohols, C16-18 is of low priority for further work based on a low hazard potential is of low priority for further work based on a low hazard potential.
There is no information available from single or repeated inhalation exposures in laboratory animals or from human experience allowing a conclusion on potential respiratory tract irritation and sensitisation of the aliphatic alcohols.
Therefore testing for Respiratory sensitisation does not need to be performed.

Justification for classification or non-classification

Based on the hazard assessment of Alcohols, C16-18 in section 2.1 and 2.2. in IUCLID 5.4., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99)and according to the criteria described in Directive 67/548 and in the CLP Regulation:

Directive 67/548

Respiratory Sensitisation Xn R42 May cause sensitization by inhalation Respiratory Irritation Xi R37 irritating to respiratory system

CLP	Respiratory Sensitisation H334 Resp. Sens. 1 May cause allergy or asthma symptoms or breath-ing difficulties if inhaled Respiratory Irritation H335 STOT SE 3 May cause respiratory irritation

It is concluded that the substance Alcohols, C16-18 does not meet the criteria to be classified for human health hazards for Inhalation - local effect: respiratory sensitisation.