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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
Study period:
December 1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study meets the EC Standards (conducted equivalent to OECD 405). Non GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no details on test animals and environmental conditions, animals were not observed for irritation 48 hours after exposure: not expected to affect the outcome of the study
Principles of method if other than guideline:
Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", Draize, John H., Woodard, Geoffrey, and Calvery, Herbert O., J. Pharm. & Exp. Ther., 82, 4, December 1944.
GLP compliance:
no
Remarks:
not present at the time of performance.

Test material

Constituent 1
Reference substance name:
Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
EC Number:
701-196-7
Cas Number:
72244-98-5
Molecular formula:
not applicable
IUPAC Name:
Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): DION® Polymercaptan Resin DPM 3-800LC
- Description: viscous, amber liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
No data

ENVIRONMENTAL CONDITIONS
No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each animal served as a scoring control.
Amount / concentration applied:
TEST MATERIAL
- Amoun applied: 0.1 mL
Duration of treatment / exposure:
Single instillation on Day 1.
Observation period (in vivo):
The eyes of each animal were examined approximately 1 minute, 1, 24 and 72 hours and 7 days after instillation of the test substance.
Number of animals or in vitro replicates:
5
Details on study design:
STUDY DESIGN:
The undiluted test material was instilled into the conjunctival sac of the right eye of each test rabbit.

OBSERVATIONS:
The eyes of each animal were examined approximately 1 minute, 1, 24 and 72 hours and 7 days after instillation of the test substance.

SCORING SYSTEM:
The irritation scores and a description of all other (local) effects were recorded.The irritation was assessed according to OECD 405.

Results and discussion

In vitro

Results
Remarks on result:
not measured/tested

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1, #2, #3, #4 and #5
Time point:
other: 24 and 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1, #2, #3, #4 and #5
Time point:
other: 24 and 72 hrs
Score:
0.5
Max. score:
2
Reversibility:
fully reversible within: 72 hrs.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
animal #1, #2, #3, #4 and #5
Time point:
other: 24 and 72 hrs
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 72 hrs.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 and 72 hrs
Score:
0
Max. score:
4
Irritant / corrosive response data:
Iridal and conjunctival irritation were noted one minute after instillation. Within 72 hours, the ocular tissues had returned to normal.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to Regulation (EC) No 1272/2008
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study with rabbits, performed equivalent to OECD 405 test guideline, slight iridal and conjunctival irritation was observed. Within 72 hours, the ocular tissues had returned to normal.
Executive summary:

The test substance DPM 3 -800LC was tested in an eye irritation study with rabbits, performed equivalent to OECD 405 test guideline.

Iridal and conjunctival irritation were noted one minute after instillation. Within 72 hours, the ocular tissues had returned to normal.

Based on the results, the substance DPM 3 -800LC does not have to be classified for eye irritation according to Regulation (EC) No 1272/2008.