Registration Dossier
Registration Dossier
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EC number: 208-873-1 | CAS number: 544-60-5
Endpoint summary
Administrative data
Description of key information
LLNA: sensitizing
GPMT: not sensitizing
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- For justification of read-across see section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The publication compared the applicability of LLNA and GPMT to different fatty acids.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction 5%, challenge 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction 5%, challenge 25%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction 5%, challenge 25%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction 5%, challenge 25%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction 5%, challenge 25%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction 5%, challenge 25%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
- Remarks on result:
- other: for 24 / 48 / 72 h after challenge
- Reading:
- rechallenge
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
- Remarks on result:
- other: for 24 / 48 / 72 h after challenge
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- For justification of read-across see section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Parameter:
- SI
- Value:
- 6.9
- Variability:
- +/- 3.6
- Test group / Remarks:
- 50%
- Parameter:
- SI
- Value:
- 14.9
- Variability:
- +/- 6.8
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 2.6
- Variability:
- +/- 1.6
- Test group / Remarks:
- 10%
- Parameter:
- other: Lymph node weights
- Value:
- 2.2
- Variability:
- +/- 0.2
- Test group / Remarks:
- 50%
- Parameter:
- other: Lymph node weights
- Value:
- 2.3
- Variability:
- +/- 0.2
- Test group / Remarks:
- 25%
- Parameter:
- other: Lymph node weights
- Value:
- 1.1
- Variability:
- +/- 0.3
- Test group / Remarks:
- 10%
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data is available on the sensitizing properties of ammonium oleate, however data on the corresponding acid oleic acid was available.
Unsaturated acids such as oleic acid activate cellular second messenger cascades, leading to the release of pro-inflammatory cytokines, such as IL-1a. These cytokines, in turn, activate Langerhans cells in the epidermis and can stimulate migration of Langerhans cells to the draining lymph nodes, where they activate hapten-independent T-cell activation. Given the chemical activity and reactivity of oleic acid, hapten formation in the epidermis is highly unlikely. Therefore, the data obtained in LLNA and GPMT with oleic acid were interpreted as hapten-independent T cell activation secondary to activation of Langerhans cells by second messengers rather than substance-inducted skin sensitization. For more information please refer to Kreiling et al., 2008.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data available, the classification criteria defined in Regulation (EC) 1272/2008 (CLP) are not met. Therefore, non-classification of the substance is warranted.
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