Registration Dossier
Registration Dossier
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EC number: 700-989-5 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is rated a "2" because it applied appropriate testing methods; however, the study predates GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- 1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich
- EC Number:
- 271-091-4
- EC Name:
- 1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich
- Cas Number:
- 68515-49-1
- IUPAC Name:
- bis(8-methylnonyl) phthalate
- Reference substance name:
- 1,2-benzenedicarboxylic acid, di-C9,C10 and C11 branched alkyl ester, C10 Rich
- IUPAC Name:
- 1,2-benzenedicarboxylic acid, di-C9,C10 and C11 branched alkyl ester, C10 Rich
- Details on test material:
- - Name of test material (as cited in study report): MRD-78-44
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bunnyville Farms, Littlestown, Pennsylvania
- Housing: indivial in metal cages
- Diet: Rabbit ration (Purina Rabbit Chow Checkers) ad libitum
- Water: ad libitum
Administration / exposure
- Type of coverage:
- occlusive
- Duration of exposure:
- 24 hours
- Doses:
- 3160 mg/kg bw
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rabbits were observed daily for mortality, and signs of toxic and pharmacologic effects. All rabbits were weighed initially, and at termination (Day14).
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 3 160 mg/kg bw
- Mortality:
- All 4 rabbits survived the 14 day test period at the 3160 mg/kg dose level.
- Clinical signs:
- other: Clinical observation included slight to marked anorexia, and slight to moderate depression in all four rabbits. At termination, all 4 rabbits appeared normal.
- Gross pathology:
- Gross pathology finding noted in teh animals sacrificed on day 14 included dark red lungs in 3 rabbits and white, raised areas on all lobes of the lungs in the 4th rabbit.
- Other findings:
- Slight to well-defined erythema was noted in two rabbits at 24 hours. Very slight erythema was noted in these two rabbits at day 3. The remaining two rabbits exhibited very slight erythema at 24 hours. Erythema in these rabbits reversed itself by day 3. No edema was noted in any of the rabbits treated.
Applicant's summary and conclusion
- Conclusions:
- The LD50 > 3,160 mg/kg bw/day.
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