Registration Dossier
Registration Dossier
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EC number: 201-550-6 | CAS number: 84-66-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- NTP Technical report on the Toxicology and carcinogenesis studies of Diethylphthalate in F344/N rats and B6C3F1 mice with Dermal initiation/promotion study of diethyl phthalate and dimethyl phthalate
- Author:
- U.S. Department of health and human services
- Year:
- 1 995
- Bibliographic source:
- National Institites of Health No. 95-3356
Materials and methods
- Principles of method if other than guideline:
- Groups of 10 male and 10 female rats were dermally administered diethyl phthalate at volumes of 0, 37.5, 75, 150, or 300 μL. Doses were applied to clipped interscapular skin five times per week for 4 weeks. Clinical findings were recorded weekly. Animals were weighed initially and weekly thereafter.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diethyl phthalate
- EC Number:
- 201-550-6
- EC Name:
- Diethyl phthalate
- Cas Number:
- 84-66-2
- Molecular formula:
- C12H14O4
- IUPAC Name:
- diethyl phthalate
- Details on test material:
- Purity >99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on test animals or test system and environmental conditions:
- Test Animals
Source: Simonsen Laboratories, Inc. (Gilroy, CA)
Age: 29 days
The animals were quarantined for 13 days before exposure.
Housing: Polycarbonate cages
Diet: NIH-07 open fonnula meal (Zeigler Brothers, Gardners, PA) ad libitum
Water (ad libitum): Automatic watering system
Environmental Conditions
Temperature: 22 - 24°C
Humidity: 32-58 %
Fluorescent light: 12 hours/day
Room air changes: minimum of 12 changes/hour
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Controls:
- yes
- Duration of treatment / exposure:
- 5 times per week for 4 weeks.
- Observation period:
- Animals observed twice daily; clinical findings, and weights recorded initially and weekly thereafter.
- Number of animals:
- 20 (10 males and 10 females)
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Observation
- Basis:
- mean
- Time point:
- other: 4 weeks
- Remarks on result:
- other: No adverse clinical signs were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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