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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 January 2017 - 02 February 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
adopted 22 July 2010
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Pidolic acid
EC Number:
202-700-3
EC Name:
Pidolic acid
Cas Number:
98-79-3
Molecular formula:
C5H7NO3
IUPAC Name:
(2S)-5-oxopyrrolidine-2-carboxylic acid
Test material form:
solid: particulate/powder
Details on test material:
white solid crystalline powder
Specific details on test material used for the study:
Batch number: 20140124
Physical state/Appearance: white crystalline solid
Storage Conditions: room temperature in the dark

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Remarks:
CBA/CaOlaHsd
Sex:
female
Details on test animals and environmental conditions:
The animals were nulliparous and non-pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the animals were in the weight range of 15 to 23 g, and were 8 to 12 weeks old.

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
25%, 10% or 5% w/w in dimethyl formamide
No. of animals per dose:
Groups of four mice/dose
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
α-Hexylcinnamaldehyde, tech., 85% was considered to be a sensitizer under the conditions of the test.

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1.08
Test group / Remarks:
5% w/w
Key result
Parameter:
SI
Value:
1
Test group / Remarks:
10% w/w
Key result
Parameter:
SI
Value:
1.38
Test group / Remarks:
25% w/w

Any other information on results incl. tables

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period.

Applicant's summary and conclusion

Conclusions:
The substance was considered to be a non-sensitizer under the conditions of the test.
Executive summary:

A study was performed to assess the skin sensitization potential of the substance in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. Three groups, each of four animals, were treated with 50 μL (25 μL per ear) of the substance as a solution in dimethyl formamide at concentrations of 25%, 10% or 5% w/w. A further group of four animals was treated with dimethyl formamide alone. The Stimulation Index at concentrations of 25%, 10% or 5% w/w was 1.08, 1.00 and 1.38, respectively. Therefore, the substance was considered to be a non-sensitizer under the conditions of the test.