Diheptyl succinate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7/02/18 - 30/03/18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diheptyl succinate

EC Number:

239-996-9

EC Name:

Diheptyl succinate

Cas Number:

15872-89-6

Molecular formula:

C18H34O4

IUPAC Name:

1,4-diheptyl butanedioate

Test material form:

liquid

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Details on animal used as source of test system:

The EpiDerm (EPI-200) human tissue model (Lot# 27961) produced by MatTek Corporation was used for this study.

Vehicle:

unchanged (no vehicle)

Details on test system:

Test materials were used as neat.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

30 µl of TA1, negative control (NC) and positive control (PC) (mesh was used for TA1, NC & PC) were applied topically to n=3 tissues per treatment group. N=3 tissues were prewet with 25 µl of DPBS. A 25 mg sharp application spoon was filled with test material (TA2). The spoon was leveled by gentle scratching of the excess material away and then applied.

Duration of treatment / exposure:

The treatments were performed at an interval of 1 minute between tissues and the tissues were incubated at 37C/5%CO2 for 35 ± 1 minutes.

Duration of post-treatment incubation (if applicable):

After 35 min, all plates were removed from the incubator and place into the biological safety cabinet until the 60-min exposure period was completedfor the first dosed tissue. The tissues were rinsed with sterile DPBS by filling and emptying the tissue inserts 15 times to remove any test material and transferred the tissues to 6-well plates pre-filled with 0.9 mL EPI-100-NMM media. The tissues were incubated in the incubator for next 24 ± 2 hours.

24 hours post-treatment the tissues were re-feed with 0.9 mL EPI-100-NMM medium and incubated at 37C/5%CO2 for an additional 18 ± 2 hours.

At the end of 18 ± 2 hours post-incubation period the tissues were removed from culture and MTT analysis was performed.

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean value of 3 replicates

Value:

101.513

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

non-irritating

Executive summary:

Study 034-18 is intended to evaluate the skin irritation potential of topically applied Diheptyl Succinate using the EpiDerm Skin Irritation Test

Study Design

 EpiDerm (EPI-200), produced by MatTek Corporation, was used to evaluate skin irritation potential of two topically applied test articles. Tissue viability following topical application of test articles was evaluated via MTT assay.

Results

 PC (5% SDS) decreased tissue viability to 2.714%. The tissue viability of tissues treated with test article 1 (TA1 (Diheptyl Succinate)) was 101.513% hence was classified as non-irritants (NI).