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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (non-GLP, no details on test substance incl. purity, only 2-hour reading, short observation period).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1980
Reference Type:
publication
Title:
Atochem (1980), Skin and Ocular Irritation test, Consultox Lab: CL80 65:2030
Author:
Atochem
Year:
2003
Bibliographic source:
cited in: OECD SIDS, 2-Dimethylaminoethylmethacrylate, CAS No: 2867-47-2, 07/2003

Materials and methods

Principles of method if other than guideline:
According to the method described in the Federal Hazardous Substances Labelling Act Regulations, Section 191.11, published in the Federal Register - 29 F.R. 13009, 1964.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-dimethylaminoethyl methacrylate
EC Number:
220-688-8
EC Name:
2-dimethylaminoethyl methacrylate
Cas Number:
2867-47-2
Molecular formula:
C8H15NO2
IUPAC Name:
2-(dimethylamino)ethyl methacrylate
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No details.

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: undiluted
Duration of treatment / exposure:
2 hours
Observation period (in vivo):
2 hours
Number of animals or in vitro replicates:
2 females
Details on study design:
0.1 mL of the test substance was instilled into one eye of each animal. The lids were gently held together for one second and the eye was then rinsed
with 20 mL Iukewarm water at 4 seconds after instillation. The eyes were examined 2 hrs after instillation. The scoring system used was that according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
3.5
Max. score:
4
Reversibility:
other: not examined
Remarks on result:
other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 2 hours
Score:
3
Reversibility:
other: not examined
Remarks on result:
other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 2 hours
Score:
4
Reversibility:
other: not examined
Remarks on result:
other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: not examined
Remarks on result:
other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 2 hours
Score:
2
Reversibility:
other: not examined
Remarks on result:
other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 2 hours
Score:
2
Reversibility:
other: not examined
Remarks on result:
other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
other: not examined
Remarks on result:
other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 2 hours
Score:
3
Reversibility:
other: not examined
Remarks on result:
other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 2 hours
Score:
3
Reversibility:
other: not examined
Remarks on result:
other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
3.5
Max. score:
4
Reversibility:
other: not examined
Remarks on result:
other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 2 hours
Score:
3
Reversibility:
other: not examined
Remarks on result:
other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 2 hours
Score:
4
Reversibility:
other: not examined
Remarks on result:
other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
Irritant / corrosive response data:
Despite the rinsing treatment severe corneal, iris and conjunctival lesions were displayed by both animals within 2 hrs of instillation. The test was
terminated at this point. lt is reasonable to assume that similar levels of injury would be produced if full scale testing were conducted, and that the
product would be classified as corrosive to the eye.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
It is reasonable to assume that similar levels of injury would be produced if full scale testing were conducted, and that the product would be classified as corrosive to the eye.