Dimethyl naphthalene-2,6-dicarboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented and scientifically acceptable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

NDC was applied for 4 hours to the pre-moistened, shaved backs of three rabbits at a dose of 0.5 g. Following unwrapping, the test sites were rinsed with approximately 2 mL of 0.9% saline. All test sites were examined for signs of dermal irritation (i.e., edema, erythema and/or eschar formation) and corrosivity (i.e., ulceration and/or necrosis) at 30-60 minutes, and 24, 48 and 72 hours following removal of the wrappings.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl naphthalene-2,6-dicarboxylate

EC Number:

212-661-4

EC Name:

Dimethyl naphthalene-2,6-dicarboxylate

Cas Number:

840-65-3

Molecular formula:

C14H12O4

IUPAC Name:

2,6-dimethyl naphthalene-2,6-dicarboxylate

Test material form:

solid: flakes

Details on test material:

CAS number: 840-65-3

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

None stated.

Test system

Type of coverage:

not specified

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

No additional data

Duration of treatment / exposure:

4 hours

Observation period:

30-60 minutes, 24, 48 and 72 hours

Number of animals:

3 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were rinsed with approximately 2 mL of 0.9% saline.
- Time after start of exposure: 4 hours

No additional data

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

No signs of dermal irritation were evident in any rabbit at any time during the study. The Primary Dermal Irritation Score for Dimethyl-2,6-Naphthalene Dicarboxylate (DM-2,6-NDC) is 0.0.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a dermal irritation study conducted equivalent to OECD 404 (not conducted according to GLP), no signs of irritation were seen 24, 48 and 72 hours after exposure of rabbits to NDC (mean score = 0), therefore, NDC is considered not irritating.