Registration Dossier

Toxicological information

Skin sensitisation

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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:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous

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 group
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.