Registration Dossier
Registration Dossier
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EC number: 215-951-9 | CAS number: 1459-93-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dimethyl isophthalate
- EC Number:
- 215-951-9
- EC Name:
- Dimethyl isophthalate
- Cas Number:
- 1459-93-4
- Molecular formula:
- C10H10O4
- IUPAC Name:
- 1,3-dimethyl benzene-1,3-dicarboxylate
- Test material form:
- solid: flakes
- Details on test material:
- Morflex 1129 flake, batch No. 99275, Material No. 101149
Purity: 99.85%. Impurities: dimethyl terephthalate, 0.5% maximum.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 to 3.1 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): PMI rabbit chow (diet # 5321)
- Water (e.g. ad libitum): at libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature contolled
IN-LIFE DATES: From: 13 November 2012 To: 16 November 2012
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- as a paste
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4
- Observation period:
- up to 72 hours
- Number of animals:
- 3 (1 male and 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2 cm x 3 cm
- Type of wrap if used: site covered with gauze and wraped with a porous semi-occlusive wrap. Porous non-irritating tape was used to encircle the trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Evaluation of Skin Reactions according to Draize, with Value*
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised more than 1.0 mm) 3
Severe edema (raised more than 1.0 mm, extending beyond the area of exposure 4
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no irritation was noted.
- Irritant / corrosive response data:
- No irritation was noted and all animals appeared normal
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dimethyl isophthalate (DMIP) was tested for skin irritation in New Zealand white rabbits using an OECD 404 protocol. No irritation was observed and all animals appeared normal. DMIP is not a skin irritant according to Regulation EC No. 1272/2008
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