Registration Dossier
Registration Dossier
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EC number: 700-453-0 | CAS number: 59802-05-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.10.2010 to 22.12.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
- EC Number:
- 700-453-0
- Cas Number:
- 59802-05-0
- Molecular formula:
- C26H42O4
- IUPAC Name:
- 1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD `SD`
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd
- Females nulliparous and non-pregnant: yes
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 233 to 385 g
- Housing:Animals were housed inside a barriered rodent facility
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Air changes: The animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours continuous dark per 24 hours.
IN-LIFE DATES: From: 28/10/2010 To: 18/11/2010
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: treatment area was approximately 50 mm x 50 mm
- % coverage: 10% of the total body surface area
- Type of wrap if used: porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated area of skin was washed with a mild detergent solution and then rinsed with warm water (30 - 40°C), to remove any residual test substance
- Time after start of exposure: At the end of the 24 hours exposure
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.05 mL/kg
- Constant volume or concentration used: yes
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15.
- Other examinations performed: clinical signs, body weight, dermal reactions, histopathology
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths and no treatment related clinical signs were observed.
- Clinical signs:
- There were no deaths and no treatment related clinical signs were observed.
- Body weight:
- Low bodyweight gains were recorded for two females on Day 8 and three
females on Day 15.
All remaining animals were considered to have achieved satisfactory bodyweight gains
throughout the study. - Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study
termination on Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute median lethal dermal dose (LD50) to rats of Bis(C9 (branched)alkyl) benzene-1,4-
dicarboxylate was demonstrated to be greater than 2000 mg/kg bodyweight.
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