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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Justification for read across is detailed in the report attached to the IUCLID section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
eye irritation, other
Remarks:
points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Justification for read across is detailed in the report attached to the IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline available
Principles of method if other than guideline:
None
GLP compliance:
no
Specific details on test material used for the study:
None
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
None
Vehicle:
water
Controls:
not required
Amount / concentration applied:
70 mg of was instilled into each eye.
Duration of treatment / exposure:
The eyes are examined and the grade of ocular reaction is recorded at 24, 48 and 72 hours.
Observation period (in vivo):
24 hours
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
Six albino rabbits are used for each test substance.
Details on study design:
None
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1.
Other effects:
None

Numerical Scores awarded to the ocular reactions elicited by FAT 20013/A:

Animal Number Region of eye Day
1 2 3 4 7 14 21
1 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 4 0 0 0 0 0 0
TOTAL 4 0 0 0 0 0 0
2 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 6 0 0 0 0 0 0 
TOTAL 6 0 0 0 0 0 0
3 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 2 2 0 0 0 0 0
TOTAL 2 2 0 0 0 0 0
4 Cornea 5 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 6 4 2 2 2 2 0
TOTAL 11 4 2 2 2 2 0
5 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 6 2 0 0 0 0 0
TOTAL 6 2 0 0 0 0 0
6 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 8 2 2 0 0 0 0
TOTAL 8 2 2 0 0 0 0
Total Score 37 16 4 2 2 2 0
Mean / rabbit 6 3 <1 <1 <1 <1 0
Interpretation of results:
other: Not classified
Remarks:
Classification criteria according to the CLP Regulation 1272/2008 and its amendments
Conclusions:
non-irritant to the eyes.
Executive summary:

In a study performed to determine the eye irritation potential of FAT 20013, test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 hour, 6 hours, 1 day, 2 days, 3 days, 4 days, 7 days, 14 days and 21 days. One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1. Based on these findings, FAT 20013 is considered to be a non-irritant to the eyes.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
None
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Similar substance 01 of Acid Black 213
IUPAC Name:
Similar substance 01 of Acid Black 213
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
None

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
None

Test system

Vehicle:
water
Controls:
not required
Amount / concentration applied:
70 mg of was instilled into each eye.
Duration of treatment / exposure:
The eyes are examined and the grade of ocular reaction is recorded at 24, 48 and 72 hours.
Observation period (in vivo):
24 hours
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
Six albino rabbits are used for each test substance.
Details on study design:
None

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1.
Other effects:
None

Any other information on results incl. tables

Numerical Scores awarded to the ocular reactions elicited by FAT 20013/A:

Animal Number Region of eye Day
1 2 3 4 7 14 21
1 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 4 0 0 0 0 0 0
TOTAL 4 0 0 0 0 0 0
2 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 6 0 0 0 0 0 0 
TOTAL 6 0 0 0 0 0 0
3 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 2 2 0 0 0 0 0
TOTAL 2 2 0 0 0 0 0
4 Cornea 5 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 6 4 2 2 2 2 0
TOTAL 11 4 2 2 2 2 0
5 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 6 2 0 0 0 0 0
TOTAL 6 2 0 0 0 0 0
6 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 8 2 2 0 0 0 0
TOTAL 8 2 2 0 0 0 0
Total Score 37 16 4 2 2 2 0
Mean / rabbit 6 3 <1 <1 <1 <1 0

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Classification criteria according to the CLP Regulation 1272/2008 and its amendments
Conclusions:
non-irritant to the eyes.
Executive summary:

In a study performed to determine the eye irritation potential of FAT 20013, test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 hour, 6 hours, 1 day, 2 days, 3 days, 4 days, 7 days, 14 days and 21 days. One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1. Based on these findings, FAT 20013 is considered to be a non-irritant to the eyes.