Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Screening report only. Draize scale used for the evaluation of the severity of ocular lesions. However, raw data is not available. Area of Cornea involved has been scaled additionally. The animals have been sacrificed one hour after the application of the test substance.

Data source

Reference
Reference Type:
other: acute toxicity screening report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A dose of 0.1 g of the test material was instilled into the conjunctival sac of the left eye of each of 3 rabbits, the right eye served as the untreated control. After instillation the eye lids were held together for approximately 1 second and the rabbits returned to their cages. After 1 hour the eyes were examined for irritation.
GLP compliance:
not specified

Test material

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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12-14 weeks
- 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%

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
according to the report 24 hours. However, in the results section, it is mentioned that the animals were sacrificed 1 hour after the application of the test substance.
Observation period (in vivo):
After one hour
Number of animals or in vitro replicates:
3
Details on study design:

SCORING SYSTEM: according to the test report, the Draize scale had been used for the evaluation of irritating effects. However, the scores given do not refer to the scores given in the Draize scale. No further explanation of the scoring system is given.

TOOL USED TO ASSESS SCORE: UV light and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
60
Max. score:
80
Remarks on result:
other: all animals were sacrificed after one hour exposure for humane reasons
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
8.3
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
6.7
Max. score:
20
Other effects:
all animals were sacrificed after one hour exposure for humane reasons. The nictating membrane of all animals appeared white.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the results of this study, 5-methoxymethyl-2,3-pyridine-dicarboxylic acid is classified as severely irritating to the eye (Cat.1, H318) according to Regulation (EC) No. 1272/2008 and as severely irritating to the eye (Xi, R41) according to Directive 67/548/EEC.
Executive summary:

To evaluate the eye irritating potentail of 5-methoxymethyl-2,3-pyridine-dicarboxylic acid, a dose of 0.1 g of the test material was instilled into the conjunctival sac of the left eye of each of 3 rabbits, the right eye served as the untreated control. After instillation the eye lids were held together for approximately 1 second and the rabbits returned to their cages. After 1 hour the eyes were examined for irritation. Due to the study report, the animals were sacrificed after one hour for humane reasons. Thus, it is not possible to apply the current classification criteria. Due to the high Draize scores given and due to the fact, that the nictating membrane of all animals appeared white, 5-methoxymethyl-2,3-pyridine-dicarboxylic acid is classified by expert judgment as severely irritating to the eye.