Ethyl 3-hydroxypropanoate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation, other

Remarks:

Skin sensitization study of mouse(BrdU-ELISA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2022-03-21 ~ 2022-05-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD Guideline for Testing of Chemicals: TG 442B Skin Sensitization: Local Lymph Node (Adopted: 25 June 2018)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)

GLP compliance:

yes (incl. QA statement)

Type of study:

other: This study was performed to investigate skin sensitization of Ethyl 3-hydroxy propanoate in mouse(BrdU-ELISA).

Test material

Test material information

Constituent 1

Reference substance name:

ethyl 3-hydroxypropanoate

Cas Number:

623-72-3

Molecular formula:

C5H10O3

IUPAC Name:

ethyl 3-hydroxypropanoate

Test material form:

liquid

In vivo test system

Test animals

Species:

mouse

Strain:

CBA:J

Remarks:

CBA/JCrHsd, Mouse, SPF

Sex:

female

Details on test animals and environmental conditions:

- Species/strain/sex : CBA/JCrHsd, Mouse, SPF, Female
- Supplier : KOATECH Co., Ltd.(181-21, Jinwi-ro, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, Korea)
- Number of animals : Female, 11 animals(Pre-screen test) : Female, 32 animals(Main test)
- Body weight at the time of allocation : 8 weeks old, 19.18 g – 21.15 g(Pre-screen test) 8 weeks old, 19.24 g – 21.36 g(Main test)
- Number of test animals : Female, 10 animals(Pre-screen test) Female, 30 animals(Main test)
- Body weight at the time of allocation : 9 weeks old, 21.21 g – 23.54 g(Pre-screen test)
9 weeks old, 21.44 g – 23.99 g(Main test)

Results and discussion

Positive control results:

The test substance(The vehicle control and the positive control) was spread over the
entire dorsal surface of the ear using a micropipette at a volume of 25 μL/ear.
The stimulation index was calculated to be 2.3 for the positive control substance.

In vitro / in chemico

Results

Results 1

Key result

Group:

test chemical

Run / experiment:

mean

Parameter:

other: BrdU L.I. (BrdU labelling Index)

Value:

100 %

At concentration:

0.091 other: L.I.

Cell viability:

S.I. (Stimulation Index) = Mean of BrdU L.I. in test substance group / Mean of BrdU L.I. in negative
control group
0.5 S.I.

Vehicle controls validity:

not valid

Negative controls validity:

not valid

Positive controls validity:

not valid

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Group:

test chemical

Run / experiment:

mean

Parameter:

other: BrdU L.I. (BrdU labelling Index)

Value:

50 %

At concentration:

0.119 other: L.I.

Cell viability:

S.I. (Stimulation Index) = Mean of BrdU L.I. in test substance group / Mean of BrdU L.I. in negative
control group
0.7 S.I.

Vehicle controls validity:

not valid

Negative controls validity:

not valid

Positive controls validity:

valid

Remarks on result:

no indication of skin sensitisation

Results 3

Key result

Group:

test chemical

Run / experiment:

mean

Parameter:

other: BrdU L.I. (BrdU labelling Index)

Value:

25 %

At concentration:

0.129 other: L.I.

Cell viability:

S.I. (Stimulation Index) = Mean of BrdU L.I. in test substance group / Mean of BrdU L.I. in negative
control group
0.7 S.I.

Vehicle controls validity:

not valid

Negative controls validity:

not valid

Positive controls validity:

valid

Remarks on result:

no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:

1. Clinical signs
Mice were observed for clinical signs daily.
2. Body weight
Body weights were recorded on Day 1(Immediately prior to dosing) and on Day 6.
3. Ear thickness
Ear thickness measurements were performed on Day 1 prior to dosing, on Day 3 before the test substance application and on Day 6 before sacrifice.
4. Observation of test substance application site
Skin responses at the site of test substance application were observed once each day according to “Erythema scores”.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The stimulation index(S.I.) was calculated to be 0.7, 0.7 and 0.5 for the 25 %(v/v) (G3), 50 %(v/v)(G4) and 100 %(G5) treatment groups, respectively. The positive control group(G6) has an S.I. of 2.3.

As a result of the this study, Ethyl 3-hydroxypropanoate a test substance in skin sensitization tests on mice, is considered to be a non-inducing substance for skin sensitization.

Executive summary:

This study was conducted to evaluate the skin sensitisation of Ethyl 3-hydroxy propanoate in mouse (BrdU-ELISA). Parameters measured during study period were
mortality, clinical signs, body weight changes, ear thickness and skin reactions.
No mortality was observed in the study. The body weight of the animals in the treatment groups did not deviate from the solvent control.
As a result of observing the local region treated with the test substance, no skin irritation was observed and no significant increase of ear thickness was induced by
the test substance.
The stimulation index(S.I.) was calculated to be 0.7, 0.7 and 0.5 for the 25 %(v/v) (G3), 50 %(v/v)(G4) and 100 %(G5) treatment groups, respectively. The positive control
group(G6) has an S.I. of 2.3.
As a result of the this study, Ethyl 3-hydroxypropanoate a test substance in skin sensitization tests on mice, is considered to be a non-inducing substance for skin
sensitization.