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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2014-04-14-2014-04-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
(3E)-12-[(2-{2-[(E)-[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino]propoxy}propoxy)methyl]-12-ethyl-2,2,5,8-tetramethyl-1-(morpholin-4-yl)-7,10,14-trioxa-4-azaheptadec-3-en-16-ol; 4-[(3E,20E)-12-[(2-{2-[(E)-[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino]propoxy}propoxy)methyl]-12-ethyl-2,2,5,8,16,19,22,22-octamethyl-23-(morpholin-4-yl)-7,10,14,17-tetraoxa-4,20-diazatricosa-3,20-dien-1-yl]morpholine; 4-[(3E,20E)-12-ethyl-2,2,5,8,16,19,22,22-octamethyl-23-(morpholin-4-yl)-7,10,14,17-tetraoxa-4,20-diazatricosa-3,20-dien-1-yl]morpholine
EC Number:
700-879-7
Cas Number:
1379822-00-0
Molecular formula:
NA: UVCB substance
IUPAC Name:
(3E)-12-[(2-{2-[(E)-[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino]propoxy}propoxy)methyl]-12-ethyl-2,2,5,8-tetramethyl-1-(morpholin-4-yl)-7,10,14-trioxa-4-azaheptadec-3-en-16-ol; 4-[(3E,20E)-12-[(2-{2-[(E)-[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino]propoxy}propoxy)methyl]-12-ethyl-2,2,5,8,16,19,22,22-octamethyl-23-(morpholin-4-yl)-7,10,14,17-tetraoxa-4,20-diazatricosa-3,20-dien-1-yl]morpholine; 4-[(3E,20E)-12-ethyl-2,2,5,8,16,19,22,22-octamethyl-23-(morpholin-4-yl)-7,10,14,17-tetraoxa-4,20-diazatricosa-3,20-dien-1-yl]morpholine
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: S&K LAP Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbits
- Sex: Male
- Weight at study initiation: 2500 - 3118 g
- Housing: Animals were housed individually in metal cages.
- Diet: CRLT/ny, ad libitum.
- Water: Tap water, ad libitum.
- Acclimation period: 11 days for first animal, 12 days for second animal and 13 days for third animal

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 10-15 changes/hour
- Photoperiod: Artificial light, from 6 a.m. to 6. p.m.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: a weight of 0.1 mL of the undiluted test item was used for the study in pure state, in a single dose.
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
1 hour after treatment
24 hours after treatment
48 hours after treatment
72 hours after treatment
1 week after treatment
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The eyes of the test animals were not washed out 24 hours after the application of test item, because the test substance was removed from the eye of the test animal by physiological mechanisms and the test item did not cause immediately severe irritation or corrosion after test item application.

SCORING SYSTEM:The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (2nd October 2012).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 1 week
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 1 week
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
other: discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
other: discharge
Basis:
animal #3
Remarks:
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
One hour after treatment, some conjunctival hyperaemic blood vessels (score 1) were observed in all animals. The swelling was different from normal (score 1) in one animal and obvious swelling with partial eversion of lids (score 2) was found in two animals. 24 hours after treatment, some conjunctival hyperaemic blood vessels (score 1) were observed in all animals. The swelling was different from normal (score 1) in all animals. 48 hours after treatment, some conjunctival hyperaemic blood vessels (score 1) were observed in all animals. The swelling and the discharge was different from normal (score 1) in one animal. 1 week after the treatment the study was terminated, since no primary irritation symptoms occurred.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In conclusion, test item SIKA Hardener MTJ applied to the rabbits' eye mucosa, caused slight to severe conjunctivae and slight cornea irritant effects, fully reversible within 1 week.
According to Regulation (EC) No 1272/2008 (CLP), the test item has to be classified into “Category 2 (reversible effects on the eye/irritating to eyes)”on basis of cornea opacity.

Executive summary:

The acute eye irritation study of the test item SIKA Hardener MTJ was performed in three New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 405, 2012). The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A volume of 0.1 mL of the test item was used in pure state, as a single dose. The eyes of the test animals were not washed out after the application of test item. The eyes were examined at 1, 24, 48 and 72 hours, then 1 week after the application. One hour after the treatment, slight conjunctival redness, slight to moderate chemosis and moderate to severe discharge, as well as slight cornea opacity were observed. The area of cornea involved was greater than three quarters, up to the whole area in all animals. 72 hours after treatment slight redness and cornea opacity were recorded. The area of cornea involved was greater than three quarters, up to the whole area. 1 week after the treatment, all animals were free of symptoms, so the study was terminated. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

cornea opacity: 0.33, 1.00, 1.00

iris: 0.00, 0.00, 0.00

erythema: 1.00, 1.00, 1.00

chemosis: 0.33, 0.66, 0.33

discharge: 0.00, 1.33, 0.66

No systemic toxicity was observed on the day of the treatment and during the 1-week observation period. The body weight of animals corresponded to their species and age. Sign of pain and distress as discharge was observed in all animals. These symptoms were detected between treatment day and Day 2. In conclusion, test item SIKA Hardener MTJ applied to the rabbits' eye mucosa, caused slight to severe conjunctivae and slight cornea irritant effects, fully reversible within 1 week. According to Regulation (EC) No 1272/2008 (CLP), the test item has to be classified into “Category 2 (reversible effects on the eye/irritating to eyes)” on basis of cornea opacity.