Registration Dossier
Registration Dossier
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EC number: 701-162-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Reliability: Guideline study, well-performed and well documented. read-across Justificatoin for read-across: the registraton substance is a weak acid and the read-across supporting substance is the corresponding weak base. When dissolved in water the read-across supporting substance will be converted to the registration substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The registration substance as well as the read-across supporting substances are surfactants. The surface tension is 37.2 mN/m (at 90% saturation concentration and 20°C) for the registration substance and 31.6 mN/m (at 1g/l and 20°C) for the read-across supporting substance.
Test material
- Reference substance name:
- sodium/triethanolamine- 6-(2,5-dioxo-3-C12-18-alkenyl(even and odd, branched, unsaturated)-pyrrolidin-1-yl)hexanoate
- EC Number:
- 800-766-3
- Molecular formula:
- C22H36NO4.1/2Na.1/2C6H16NO3 - C28H48NO4.1/2Na.1/2C6H16NO3
- IUPAC Name:
- sodium/triethanolamine- 6-(2,5-dioxo-3-C12-18-alkenyl(even and odd, branched, unsaturated)-pyrrolidin-1-yl)hexanoate
- Reference substance name:
- (Pentapropylensuccinimido)-hexanoic acid, sodium and triethanolamine salts
- IUPAC Name:
- (Pentapropylensuccinimido)-hexanoic acid, sodium and triethanolamine salts
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
Conditions: Standard laboratory conditions. The animal room was air-conditioned with 10 - 15 air changes per hour. The air was continuously monitored for
temperature and relative humidity. The ranges for room temperature and relative humidity were 22 ± 3 °C and 30 - 70%, respectively. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours darkness. Music was played during the daytime light period.
Accommodation: In groups of up to ten in stainless steel cages with standard softwood bedding (‘Lignocel’ J. Rettenmaier & Söhne GmbH & Co KG, 73494 Rosenberg / Germany, imported by ProvimiKliba AG, 4303 Kaiseraugst / Switzerland).
Diet: Teklad Global Guinea pig diet 2040C (batch no. 26/12, provided by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland), ad libitum. A haystick 4646 (batch no. 67/11, Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) was provided for environmental enrichment. Results of analyses for contaminants are archived at Harlan Laboratories Ltd.
Water: Community tap-water from Itingen ad libitum in water bottles. Results of bacteriological, chemical and contaminant analyses are archived at Harlan
Laboratories Ltd.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- intradermal induction with 0.2% in water; epicutaneous induction with 100% (undiluted); challege with 10% in water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- intradermal induction with 0.2% in water; epicutaneous induction with 100% (undiluted); challege with 10% in water
- No. of animals per dose:
- 10 for treated group and 5 for control. Additionally 3 animals were used for pretest.
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effect
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% challenge. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No effect.
Any other information on results incl. tables
Skin Reactions in the Pretest:
Intradermal Pretest:
Necrosis was observed at 5% after 24 hours. Erythema and blanching was observed at 1% after 24 hours. Erythema was observed at 0.2 %.
Epidermal Pretest: Erythema of score up to 2 was observed at 100%. Erythema of score 1 and scaling was observed at 30 and 10 %. No effect was found at 3%.
Skin Reactions in the Main Test:
Intradermal Induction:
The expected and commonly observed findings after FCA injection such as erythema, oedema, necrotizing dermatitis, encrustation and exfoliation of encrustation were noted.
Epidermal Induction:
No skin reaction were observed in the control group after treatment with purified water. Discrete or patchy erythema was observed in 8 of 10 test group animals 24 hours after treatment with 100% test item. Discrete or patchy erythema was still observed in 2 test group animals 48 hours after treatment with 100% test item.
Challenge:
No skin reations were observed in any of the control and test animals after the challenge with the highest tested non-irritating concentration of 10% test item in purified water.
Body Weights Development in the Main Test:
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The skin sensitization potential of the registration substance is assessed by use of data on the read-across supporting substance. No significant skin sensitization property can be assigned for the registration substance.
- Executive summary:
The skin sensitization potential of the registration substance is assessed by read-across approach using (Pentapropylensuccinimido)-hexanoate, sodium and triethanolamine salt as read-across supporting substance.
The read across supporting substance was investigated for its skin sensitization potential according to the OECD Guideline 406.
The registration substance is a non skin sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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