sodium 4-[(4-chlorobenzoyl)amino]benzoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

see "Principles of method if other than guideline" for further information

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

yes

Remarks:

see "Principles of method if other than guideline" for further information

Principles of method if other than guideline:

The standard deviation for the percentage viability results of the test item treated tissues exceeded the <18% assay acceptance criterion. The standard deviation for the three identically treated test item treated tissues was 19.4. However it was considered that this would not necessarily invalidate the results:
Unequivocal negative results were obtained for the three identically treated test item treated tissues. Also the negative and positive control tissues met the appropriate acceptance criteria. It was considered that the results of the study were acceptable on the basis that the test system proved sensitive to the positive control and the test item did not induce a response close to the irritation cut off of <50% for any of the three identically treated tissues.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

sodium 4-[(4-chlorobenzoyl)amino]benzoate

EC Number:

807-461-4

Cas Number:

1489170-67-3

Molecular formula:

C14H9ClNNaO3

IUPAC Name:

sodium 4-[(4-chlorobenzoyl)amino]benzoate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Storage condition of test material: room temperature in the dark
- Description: white powder

Test animals

Species:

other: EpiDermTM tissue consisting of human-derived epidermal keratinocytes

Strain:

other: not applicable

Details on test animals or test system and environmental conditions:

not applicable

Test system

Type of coverage:

other: not applicable

Preparation of test site:

other: not applicable

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg

Duration of treatment / exposure:

15 min

Observation period:

post incubation for 42h

Number of animals:

not applicable, 3 replicates / treatment group

Details on study design:

TEST SITE
- coverage: the test item was applied topically to the corresponding tissues ensuring uniform covering.

REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing DPBS with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of DPBS to gently remove any residual test item.
- Time after start of exposure: 15 min

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: relative mean absorbance, MTT assay

Value:

97.4

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 15min + 42h. Reversibility: other: not applicable. Remarks: test item. (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: relative mean absorbance, MTT assay

Value:

14.9

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 15min + 42h. Reversibility: other: not applicable. Remarks: positive control. (migrated information)

Results 3

Irritation / corrosion parameter:

other: other: relative mean absorbance, MTT assay

Value:

100

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 15min + 42h. Reversibility: other: not applicable. Remarks: negative control. (migrated information)

In vivo

Irritant / corrosive response data:

The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 97.4% (threshold for irritancy: ≤ 50%), consequently the test item was not irritant to skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: EU GHS

Conclusions:

The test item was classified as non-irritant. The following classification criteria apply:
EU DSD & CLP Not classified for Irritation.
UN GHS Not classified for Irritation (category 3 can not be determined).
The study was performed under GLP according to OECD guideline 439 and EU Method B.46 and therefore reliability of Klimisch 1 has been assigned.