sodium/triethanolamine- 6-(2,5-dioxo-3-C12-18-alkenyl(even and odd, branched, unsaturated)-pyrrolidin-1-yl)hexanoate

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

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliability: Guideline study, well-performed and well documented.

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 is a surfactant. The LLNA is not an appropriate test system for surfactants according to the Guideline.

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.

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

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.

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.

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.

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. The registration substance is a non-sensitizer.

Executive summary:

The registration substance was investigated for its skin sensitization potential according to the OECD Guideline 406.

The registration substance is a non-sensitizer.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

One GPMT (Guinea Pig Maximization Test) on the registration substance and one GMPT on the read-across supporting substance, (Tetrapropylensuccinimido)-caproic acid is available. None of the animals responded in both studies.

The registration substance is a non skin sensitizer. No classification is warranted.

Justification for not performing the LLNA:

The registration substance as well as the read-across supporting substance are surfactants (31.6 mN/m for the registration substance and 38.2 mN/m for the read-across supporting substance at 1g/l and 20°C).

Migrated from Short description of key information:
The registration substance is a non skin sensitizer.

Justification for selection of skin sensitisation endpoint:
Guideline study; well-performed and well-documented.

Justification for classification or non-classification

The registration substance was investigated for its skin sensitization potential according to the OECD Guideline 406. None of the treated animals in the induction phase responded to the challenge. No classification is warranted.