Octadecan-1-ol, ethoxylated, phosphates

Endpoint summary

Description of key information

The test material is considered not to be sensitising based upon read across.

The target substance, Octadecan-1-ol, ethoxylated, phosphates, and the analogous reference substances, Phosphoric acid, octadecyl ester, and Alcohols, C16-18, ethoxylated, phosphates, are fatty alcohol phosphate esters and weak anionic surfactants with extremely low water solubility and very high lipophilicity.  None of them is expected to be bioavailable.

The skin sensitization information available from SARanalysis, the lack of bioavailabilitybased on Lipinski’s Rule, the results of the Ames Test using the target substance, and the results of an LLNA on the reference substance,Phosphoric acid, octadecyl ester, provide sufficient evidence to conclude thatOctadecan-1-ol, ethoxylated, phosphatesis not a skin sensitizer.

The target and reference substances, are anionic surfactants, with low water solubility and high log Kow.  The SAR analysis shows that both target and reference substances are similar in this respect and may be hydrolyzed in water, releasing phosphoric acid and fatty AEs or fatty alcohols under neutral conditions.  The SAR analysis for ER binding also shows that both target and reference substances, their aqueous hydrolysates, and skin metabolites are considered non-estrogen binders.

Based upon all of the information presented, read-across from the existing experimental data for the analogous reference substances to the target substance is scientifically justified for this endpoints.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May to July 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The target substance, Octadecan-1-ol, ethoxylated, phosphates, and the analogous reference substances, Phosphoric acid, octadecyl ester, and Alcohols, C16-18, ethoxylated, phosphates, are fatty alcohol phosphate esters and weak anionic surfactants with extremely low water solubility and very high lipophilicity. None of them is expected to be bioavailable.

The skin sensitization information available from SAR analysis, the lack of bioavailability based on Lipinski’s Rule, the results of the Ames Test using the target substance, and the results of an LLNA on the reference substance, Phosphoric acid, octadecyl ester, provide sufficient evidence to conclude that Octadecan-1-ol, ethoxylated, phosphates is not a skin sensitizer.

The target and reference substances, are anionic surfactants, with low water solubility and high log Kow. The SAR analysis shows that both target and reference substances are similar in this respect and may be hydrolyzed in water, releasing phosphoric acid and fatty AEs or fatty alcohols under neutral conditions. The SAR analysis for ER binding also shows that both target and reference substances, their aqueous hydrolysates, and skin metabolites are considered non-estrogen binders.

Based upon all of the information presented, read-across from the existing experimental data for the analogous reference substances to the target substance is scientifically justified for this endpoints.

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Animals were nulliparious and non-pregnant
At least 5 days of acclimatisation provided
Weight: 15 to 23 g
Age: 8 to 12 weeks old
Animals individually housed in solid floor suspended cages.
Free access to food and tap water available for the animals.
The temperature and humidity were controlled to remain within the range 19 - 25ºC and 30 to 70% respectively.

Vehicle:

other: Butanone

Concentration:

25ul of solution with a concentration of 10, 5 & 2.5% w/w in butanone.

No. of animals per dose:

Four.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Positive control results:

The positive control (85%) was considered to be a sensitiser under the conditions of the test.

Parameter:

SI

Remarks on result:

other: Stimulation index results: 2.5% w/w concentration, 1.99 stimulation index 5% w/w concentration, 1.45 stimulation index 10% w/w concentration, 2.66 stimulation index

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: see Remark

Remarks:

The results of a study completed at good quality European Union (EU) laboratory according to OECD Guideline 429 (Local Lymph node assay) and according to GLP determined that Phosphoric acid, octadecyl ester was a non-sensitizer. The disintegrations per minute (DPM) were found to be: Vehicle, 1574.25 (dpm) 2.5% w/w concentration, 3129.90 (dpm) 5% w/w concentration, 2275.33 (dpm) 10% w/w concentration, 4192.38 (dpm)

Study completed at good quality European Union (EU) laboratory according to OECD Guideline 429 (Local Lymph node assay) and according to GLP. The Skin sensitization study determined that the test material was found to be a non-sensitizer under the conditions of the test.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is not sensitising.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available