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Toxicological information

Acute Toxicity: dermal

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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:
1991

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

Constituent 1
Chemical structure
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

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.
Body weight:
The initial mean body weights of the male and female rabbits was 3.07 kg, and 2.99 kg, respectively. Mean body weights increased 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.