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Registration Dossier
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EC number: 212-661-4 | CAS number: 840-65-3
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:
- 1 990
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
- 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
Constituent 1
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.
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