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Diss Factsheets

Administrative data

Description of key information

skin
rabbit, 4 h semiocclusive: not irritant (OECD 404; BASF AG 1986)
eye 
rabbit, 0.1 mL, not rinsed: risk of serious eye damage (OECD 405, BASF AG 1986)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-04-08 to 1986-04-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, non GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Mean weight at study initiation: male 2.76 kg; females 2.86 kg
- Housing: single in stainless steel cages
- Diet: Kliba 341, 4mm, Fa. Klingentalmuehle AG, Kaiseraugst, CH, ca. 130 g/d
- Water: tap water, ca. 250 mL/d
- Acclimation period: at least 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
water
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 80% (w/w)
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5*2.5 cm; upper third of the back or flanks
- Type of wrap if used: four layers of absorbent gauze plus porous bandage


REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1)


SCORING SYSTEM: OECD Draize scoring system
30 -60 min after patch removal the first reading was performed; the relevant readings for classification were performed after 24, 48 and 72 hours.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
No irritant effects seen in any reading.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-04-08 to 1986-04-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, non GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Mean weight at study initiation: male 3.25 kg; females 3.41 kg
- Housing: single in stainless steel cages
- Diet: Kliba 341, 4mm, Fa. Klingentalmuehle AG, Kaiseraugst, CH, ca. 130 g/d
- Water: tap water, ca. 250 mL/d
- Acclimation period: at least 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Application was once; the eyes were not washed out
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not rinsed

SCORING SYSTEM: OECD Draize scoring system
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 15 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Remarks on result:
other: loss of corneal tissue, loss of hair at the margins of the eyelids, small retractions in the eyelids and suppuration observed at the final reading; see table for details
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 15 d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 21 d
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
2
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
1.2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 15 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 15 d

Animal  Reading  Opacity Iritis Redness Chemosis Symptoms
1 1 h 0 0 2 2  
2 1 h 0 0 2 2  
3 1 h 0 0 2 2  
1 24 h 1 0 2 2  
2 24 h 1 0 1 0 Small retractions in the eyelids
3 24 h 1 0 1 0  
1 48 h 1 1 2 2 Small retractions in the eyelids/ Suppuration 
2 48 h 1 0 0 0 Small retractions in the eyelids 
3 48 h 1 0 2 0 Loss of corneal tissue
1 72 h 1 1 2 1 Small retractions in the eyelids/ Suppuration/ Loss of corneal tissue 
2 72 h 1 0 0 0 Small retractions in the eyelids
3 72 h 1 1 1 0 Small retractions in the eyelids / Loss of corneal tissue
1 8 d 2 1 2 1 Small retractions in the eyelids/ Suppuration / Loss of corneal tissue/ pupil contracted/ Loss of hair at the margins of eyelids
2 8 d 1 0 0 0 Small retractions in the eyelids
3 8 d 2 0 0 0 Small retractions in the eyelids / Loss of corneal tissue/ Loss of hair at the margins of eyelids
1 15 d 2 0 0 0 Small retractions in the eyelids/ Suppuration/ Loss of corneal tissue/ pupil contracted/ Loss of hair at the margins of eyelids
2 15 d 0 0 0 0 Small retractions in the eyelids
3 15 d 2 0 0 0 Small retractions in the eyelids/ Loss of corneal tissue/ Loss of hair at the margins of eyelids
1 21 d 2 0 0 0 Small retractions in the eyelids/ Suppuration / Loss of corneal tissue/ Loss of hair at the margins of eyelids
2 21 d 0 0 0 0 Small retractions in the eyelids
3 21 d 2 1 0 0 Small retractions in the eyelids/ Loss of corneal tissue/ Loss of hair at the margins of eyelids
1 24 - 72 h 1.00 0.67 2.00 1.67  
2 24 - 72 h 1.00 0.00 0.33 0.00  
3 24 - 72 h 1.00 0.33 1.33 0.00  
mean  24 - 72 h 1.00 0.33 1.22 0.56  
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are valid in vivo data available for the assessment of the skin and eye irritation potential of ureido methacrylate.

Skin

Clipped, intact skin of three Vienna White rabbits was exposed to 0.5 g ureido methacrylate (purity > 99%) in water for 4 hours under semiocclusive conditions following OECD test guideline 404 (BASF AG 1987). The exposure of the test caused no erythema and no edema within 72 hours. Therefore, the substance has not to be classified as skin irritant. Further studies, which followed the same guideline (Rohm & Haas 2002) or the Draize test procedure with occlusive dressing for 24 h (Rohm & Haas 1976), supported this assessment. 

 

Eye

An OECD guideline conform study was performed by BASF AG (1982). Eyes of three Vienna White rabbits received 0.1 mL of the unchanged test substance (purity >99%) into the conjunctival sac and were left unwashed. In the relevant reading period between 24 and 72 h, the mean scores for cornea, iris, conjunctivae redness and chemosis were 1, 0.3, 1.2 and 0.6. Conjunctival and iridal effects were not fully reversible within 21 d in one animal. Corneal opacity was observed at the final reading after 21 d in two animals. Additional findings were small retractions in all animals and loss of corneal tissue, loss of hair at the margins of eyelids in two animals and suppuration in one animal. Ureido methacrylate has therefore to be considered as serious risk for eye damage (R41 according to 67/548/EEC and eye irritation Cat. 1 according to UN-GHS, respectively). Further studies, which followed the same guideline (Rohm & Haas 2002) or the Draize test procedure (Rohm & Haas 1976, 1977), supported this assessment. 

Respiratory system

No data available


Justification for selection of skin irritation / corrosion endpoint:
The most reliable study was selected. Study was conducted in compliance with OECD guideline.

Justification for selection of eye irritation endpoint:
The most reliable study was selected. Study was conducted in compliance with OECD guideline.

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin

Based on the low potential of ureido methacrylate for skin irritation, the substance has not to be classified as skin irritant neither according to Directive 67/548/EEC (DSD) nor according to Regulation (EC) No 1272/2008 (CLP, GHS).

Eye

Corneal and iridal effects were not fully reversible within 21 in an OECD guideline conform study. Additionally, loss of corneal tissue was observed in two of three animals. Regarding this, ureido methacrylate has to be considered as serious risk for eye damage (Xi, R41 according to Directive 67/548/EEC and eye damage cat. 1, H318 according to Regulation (EC) No 1272/2008, respectively).