Hexyl chloroformate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EC) No 440/2008

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EU) Nº 640/2012

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexyl chloroformate

EC Number:

228-036-4

EC Name:

Hexyl chloroformate

Cas Number:

6092-54-2

Molecular formula:

C7H13ClO2

IUPAC Name:

hexyl carbonochloridate

Details on test material:

- Name of test material (as cited in study report): n-Hexylchloroformate
- Physical state: liquid

Test animals

Species:

other: EpiDerm™ tissues (reconstructed three dimensional human epidermis model)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: negative and positive controls

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 50 μL (corrosion test) or 30 μL (irritation test)

Duration of treatment / exposure:

3 minutes and 1 hour (corrosion test) or 1 hour with 42 hours post incubation (irritation test).

Details on study design:

The test consists of a single topical exposure of the test substance to the surface of a human reconstituted epidermis model for 3 minutes and 1 hour (corrosion test) or 1 hour with 42 hours post incubation (irritation test) followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of the yellow, water-soluble MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide), present in cell mitochondria, into a blue formazan salt that is measured quantitatively after isopropanol –extraction from the tissues. The optical density of the extracts of test substance treated tissues is compared to negative control values from tissue treated with de-ionized water or PBS and is expressed as relative tissue viability.
- Negative control (NC): de-ionized water (corrosion test) / PBS, sterile (irritation test)
- Positive control (PC): 8 N KOH (corrosion test) / 5% SDS in de-ionized water, sterile (irritation test)

- The corrosion test was performed in duplicate.
- The irritation test in triplicate.

Evaluation criteria:
- Corrosion test (viability as % of negative control): 3 min: <50 = Corrosive; 3 min ≥50 and 1 hour <15 = Corrosive; 3 min: ≥ 50 and 1 hour ≥15 = Non-corrosive
- Irritation test (viability as % of negative control): ≤ 50 = Irritant; >50 = Non-irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Cell viablity

Basis:

mean

Time point:

other: 3 minutes exposure

Score:

99

Remarks on result:

other: Corrosion test (% viablity relative to control)

Results 2

Irritation parameter:

other: Cell viability

Basis:

mean

Time point:

other: 1 hour exposure

Score:

97

Remarks on result:

other: Corrosion test (% viablity relative to control)

Results 3

Irritation parameter:

other: Cell viabilty

Basis:

mean

Time point:

other: 1 h exposure, 42 hours postincubation

Score:

104

Remarks on result:

other: Irritation test (% viablity relative to control)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information