Registration Dossier
Registration Dossier
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EC number: 212-661-4 | CAS number: 840-65-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November to December 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a reliable method and to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- NDC was applied at a dose of 2 g/kg of body weight to the shaved backs of five male and five female rabbits. The test article was left in contact with the skin for 24 hours and then removed. The rabbits were observed during this time and for 14 days thereafter.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Johnson Rabbit Ranch
- Age at study initiation: 3-4 months of age
- Weight at study initiation: 2.33-3.00 kg
- Housing: Housed individually in stainless steel cages measuring 61.0 x 45.5 x 41.0 cm.
- Diet (e.g. ad libitum): Provided with approximately 150 g of Purina Lab Rabbit Chow HF #5326 daily.
- Water (e.g. ad libitum): Reverse osmosis-purified water was supplied ad libitum by means of an automatic watering system.
-Acclimation period: Approximately three weeks.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 20%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From:29 November 1990 To 14 December 14 1990
No additional information
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 240 cm2
- Type of wrap if used: Covered with12.8 x 11.5 cm surgical dressing. The dressing was then covered by plastic film and secured by lint-free cloth and an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was wiped gently with gauze and 0.9% saline to remove residual Dimethyl-2,6-Naphthalene Dicarboxylate.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg body weight
No additional information. - Duration of exposure:
- 24 hours
- Doses:
- 2 g/kg of body weigh
- No. of animals per sex per dose:
- five male and five female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All test rabbits were observed approximately 3/4, 2, 3, 4-1/4 and 5 hours after dosing and at least once per day for 14 days after removal of the wrappings. All test animals were weighed immediately prior to dosing and the weights used for dosage calculations. The rabbits were also weighed seven days following Dimethyl-2,6-
Naphthalene Dicarboxylate application and at study termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
No additional information. - Statistics:
- None stated
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Gross pathology:
- Gross necropsy findings was within normal limits in all study rabbits.
- Other findings:
- No information provided
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median acute lethal dermal dose (LD50) for NDC is greater than 2 g/kg of body weight.
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