Registration Dossier

Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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:
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.