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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 from 04th to 13rd, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
The complete study report is not available, thus some details about test conditions are missing.
Justification for type of information:
Justification for read-across is detailed in the report attached to the IUCLID section 13.
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
December from 04th to 13rd, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
The complete study report is not available, thus some details about test conditions are missing.
Justification for type of information:
Justification for read-across is detailed in the report attached to the IUCLID section 13.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Amount / concentration applied:
0.1 ml (93 mg) of the test material as administered to the non irrigated eye.
Duration of treatment / exposure:
4 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
Three rabbits
Details on study design:
SCORING SYSTEM
Ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration.
Irritation parameter:
cornea opacity score
Basis:
animal: 2/3
Time point:
24/48/72 h
Score:
< 1
Irritation parameter:
iris score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 1
Irritation parameter:
conjunctivae score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2
Irritation parameter:
chemosis score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2
Irritant / corrosive response data:
Maximum Group Mean Score: 14.3, mild irritant (class 4 on 1-8 scale)

Individual reactions included orange coloured staining of the eye and fur surrounding the eye, translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation.

Individual and Mean Scores for Cornear lris and Conjunctivae for EU Labelling Regulations

68 male Mean 24/48/72 hrs 85 male Mean 24/48/72 hrs 86 male Mean 24/48/72 hrs
Time After Treatment 24 hrs 48 hrs 72 hrs 24 hrs 48 hrs 72 hrs 24 hrs 48 hrs 72 hrs
Degree of Comeal Opacity 0 0 0 0.00 2 2 1 1.67 0 0 0 0.00
Iridial Inflammation 0 0 0 0.00 1 1 0 0.67 0 0 0 0.00
Conjunctival Redness 1 0 0 0.33 2 2 1 1.67 1 1 0 0.67
Conjunctival Chemosis 0 0 0 0.00 2 2 0 1.33 0 0 0 0.00

Individual Scores for Ocular Irritation

68 male 85 male 86 male
Time After Treatment 1hr 24 hrs 48 hrs 72 hrs 1hr 24 hrs 48 hrs 72 hrs 7 days 1hr 24 hrs 48 hrs 72 hrs
Degree of Comeal Opacity (E) 0 0 0 0 0S 2S 2 1 0 0S 0 0 0
Area of Corneal Opacity (F) 0 0 0 0 0 2 2 1 0 0 0 0 0
Score (ExF)x5 0 0 0 0 0 20 20 5 0 0 0 0 0
Iridial Inflammation (D) 0 0 0 0 0S 1S 1 0 0 0S 0 0 0
Score (Dx5) 0 0 0 0 5 5 5 0 0 0 0 0 0
Conjunctival Redness (A) 1S 1 0 0 1S 2S 2 1 0 1S 1 1 0
Conjunctival Chemosis (B) 0 0 0 0 1 2 2 1 0 0 0 0 0
Conjunctival Discharge (C) 1Sf 0Sf 0Sf 0Sf 2Sf 3Sf 2Sf 1Sf 0 1Sf 0Sf 0Sf 0Sf
Score (A+B+C)x2 4 2 0 0 8 14 12 6 0 4 2 2 0
Total Score 4 2 0 0 8 39 37 11 0 4 2 2 0

S = orange caloured staining

Sf = orange staining of the fur around the eye

Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
Not classified, according to the CLP Regulation (EC 1272/2008)
Executive summary:

A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit. The method followed OECD Guidelines No. 405 and Method B5 of Commission Directive 92/69/EEC. A single application 0.1 ml (93 mg)of the test material was administered to the non irrigated eye of three rabbits. Ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration.

Individual reactions included orange coloured staining of the eye and fur surrounding the eye, translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation.

Maximum Group Mean Score: 14.3, mild irritant (class 4 on 1-8 scale)

Conclusion

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in at least two of three tested animals.

Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
0.1 ml (93 mg) of the test material as administered to the non irrigated eye.
Duration of treatment / exposure:
4 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
Three rabbits
Details on study design:
SCORING SYSTEM
Ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 2/3
Time point:
24/48/72 h
Score:
< 1
Irritation parameter:
iris score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 1
Irritation parameter:
conjunctivae score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2
Irritation parameter:
chemosis score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2
Irritant / corrosive response data:
Maximum Group Mean Score: 14.3, mild irritant (class 4 on 1-8 scale)

Individual reactions included orange coloured staining of the eye and fur surrounding the eye, translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation.

Any other information on results incl. tables

Individual and Mean Scores for Cornear lris and Conjunctivae for EU Labelling Regulations

68 male Mean 24/48/72 hrs 85 male Mean 24/48/72 hrs 86 male Mean 24/48/72 hrs
Time After Treatment 24 hrs 48 hrs 72 hrs 24 hrs 48 hrs 72 hrs 24 hrs 48 hrs 72 hrs
Degree of Comeal Opacity 0 0 0 0.00 2 2 1 1.67 0 0 0 0.00
Iridial Inflammation 0 0 0 0.00 1 1 0 0.67 0 0 0 0.00
Conjunctival Redness 1 0 0 0.33 2 2 1 1.67 1 1 0 0.67
Conjunctival Chemosis 0 0 0 0.00 2 2 0 1.33 0 0 0 0.00

Individual Scores for Ocular Irritation

68 male 85 male 86 male
Time After Treatment 1hr 24 hrs 48 hrs 72 hrs 1hr 24 hrs 48 hrs 72 hrs 7 days 1hr 24 hrs 48 hrs 72 hrs
Degree of Comeal Opacity (E) 0 0 0 0 0S 2S 2 1 0 0S 0 0 0
Area of Corneal Opacity (F) 0 0 0 0 0 2 2 1 0 0 0 0 0
Score (ExF)x5 0 0 0 0 0 20 20 5 0 0 0 0 0
Iridial Inflammation (D) 0 0 0 0 0S 1S 1 0 0 0S 0 0 0
Score (Dx5) 0 0 0 0 5 5 5 0 0 0 0 0 0
Conjunctival Redness (A) 1S 1 0 0 1S 2S 2 1 0 1S 1 1 0
Conjunctival Chemosis (B) 0 0 0 0 1 2 2 1 0 0 0 0 0
Conjunctival Discharge (C) 1Sf 0Sf 0Sf 0Sf 2Sf 3Sf 2Sf 1Sf 0 1Sf 0Sf 0Sf 0Sf
Score (A+B+C)x2 4 2 0 0 8 14 12 6 0 4 2 2 0
Total Score 4 2 0 0 8 39 37 11 0 4 2 2 0

S = orange caloured staining

Sf = orange staining of the fur around the eye

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
Not classified, according to the CLP Regulation (EC 1272/2008)
Executive summary:

A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit. The method followed OECD Guidelines No. 405 and Method B5 of Commission Directive 92/69/EEC. A single application 0.1 ml (93 mg)of the test material was administered to the non irrigated eye of three rabbits. Ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration.

Individual reactions included orange coloured staining of the eye and fur surrounding the eye, translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation.

Maximum Group Mean Score: 14.3, mild irritant (class 4 on 1-8 scale)

Conclusion

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in at least two of three tested animals.

Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.