2,3-Pyridinedicarboxylic acid, 5-(methoxymethyl)-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Toxicity screening report, limited information given only; no data on GLP compliance, no guideline mentioned. However, sufficient information for a classification decision.

Data source

Reference

Reference Type:

other: acute toxicity screening report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Principles of method if other than guideline:

The test site was prepared on each animal by clipping the trunk free of hair with electric clippers and a number 40 blade approximately 24 hours prior to testing. The test material was applied by spreading the test material on a plastic sheet, moistening the test material with tap water
placing the test animal, ventral side down, on the test material, bringing the plastic wrap around the body and then securing the ends with adhesive tape. The area of application encompassed approximately 10% of the body surface area. The plastic wrap was then covered with a cloth bandage to protect the plastic wrap from damage. 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 wiping the test site with the cloth wrap.

GLP compliance:

not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-methoxymethyl-2,3-pyridine-dicarboxylic acid

IUPAC Name:

5-methoxymethyl-2,3-pyridine-dicarboxylic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2.16 - 2.49 kg
- Housing: Standard stainless steel wire cages with automatic watering.
- Diet (e.g. ad libitum): Purina Rabbit Chow (nonmedicated), available ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70%

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: moistened with tap water

Details on dermal exposure:

The test site was prepared on each animal by clipping the trunk free of hair approximately 24 hours prior to testing. The test material was applied by spreading the test material on a plastic sheet, moistening the test material with tap water placing the test animal, ventral side down, on the test material, bringing the plastic wrap around the body and then securing the ends with adhesive tape. The area of application encompassed approximately 10% of the body
surface area. The plastic wrap was then covered with a cloth bandage to
protect the plastic wrap from damage. 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 wiping the test site
with the cloth wrap.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male animals tested; only one dose

Control animals:

no

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality or clinical signs.

Clinical signs:

other: None observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, 5-methoxymethyl-2,3-pyridine-dicarboxylic acid does not need to be classified for acute dermal toxicity according to Regulation (EC) No. 1272/2008 and according to Directive 67/548/EEC.