dimethyl 5-methylpyridine-2,3-dicarboxylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl 5-methylpyridine-2,3-dicarboxylate

EC Number:

601-161-5

Cas Number:

112110-16-4

Molecular formula:

C10 H11 N O4

IUPAC Name:

Dimethyl 5-methylpyridine-2,3-dicarboxylate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Inc., Stoneridge, NY
- Age at study initiation: approximately 9-10 weeks
- Weight at study initiation: 214 g to 340 g
- Housing: individually in suspended wire stainless-steel cages
- Diet (e.g. ad libitum): PMI Certified Rodent Chow #5002 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 4°C
- Humidity (%): 50% ± 20%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: approximately 10% of the body surface area
- Type of wrap if used: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the 24 hour exposure period; with tap water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: The test material was moistened with approximately 0.5 mL tap water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Statistics:

No statistical analysis was done.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no deaths occured during the 14-day test period.

Clinical signs:

Clinical signs, limited to chromodacryorrhea in 2 males only, appeared at two days postdosing and persisted through day seven.

Body weight:

All animals gained weight during the study.

Gross pathology:

There were no gross pathological changes noted in animals which were sacrificed at the termination of the study.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

It was concluded that the dermal LD50 of 2,3,-Pyridinedicarboxylic acid, 5-methyl-, 2,3-dimethyl ester was greater than 2,000 mg/kg for both male and female rats.

Executive summary:

Five male and 5 female SD rats were subjected to the study. The rats were dosed dermally with 2,3,-Pyridinedicarboxylic acid, 5-methyl-, 2,3-dimethyl ester at a dose level of 2,000 mg/kg bw. The test material, was placed on a porous gauze covering and moistened with approximately 0.5 mL of tap water. The gauze was then placed on the dorsal area of the trunk and covered with a plastic wrap. The area of application encompassed approximately 10% of the body surface area. The test material, gauze covering, and plastic wrap were then covered with an elastic adhesive bandage. The test material was held occluded under the impervious plastic wrap in continuous 24 hour contact with the shaved skin. At the end of the 24 hour exposure period the wraps were removed and any remaining test material removed by irrigating the test site with tap water. The animals were observed for clinical signs daily during the 14-day test period. Body weights were recorded on the day of dosing (day 0), day 7 and at termination (day 14). Necropsies were performed on all survivors at the end of the 14-day observation period.

Clinical signs, limited to chromodacryorrhea in males only, appeared at two days postdosing and persisted through day seven. All animals survived the 14-day test period. All animals gained weight during the study. There were no gross pathological changes noted in animals which were sacrificed at the termination of the study.