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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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Principles of method if other than guideline:
Three male rabbits were administered 100 mg test item in the right eye; the left eye served as a control. The eyes were evaluated 30 minutes, 24, 48 and 72 hours and 4 and 7 days after the administration of the test item.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Acid Black 076
IUPAC Name:
Acid Black 076
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: all animals were housed in individual cages
- Diet: a standard laboratory diet were provided ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 to 70 %
- Air changes: approximately 15 changes per hour.
- Photoperiod: 12 hours cycle dark/light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
APPLICATION
- Amount applied: 100 mg was placed undiluted into the right conjunctival sac; the eyelids were then gently held together for two seconds
Duration of treatment / exposure:
Single application
Observation period (in vivo):
72 hours with observations at 30 minutes, 24, 48 and 72 hours
Number of animals or in vitro replicates:
Three male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: unrinsed
- Pre-test: prior to application, the eyes of each rabbit were examined for pre-existing casual injury

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: unrinsed eye
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: unrinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: unrinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: unrinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: unrinsed eye
Irritation parameter:
chemosis score
Basis:
animal: #1 and #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: unrinsed eye
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: unrinsed eye

Any other information on results incl. tables

Table 1: Summary of ocular findings.

Treatment unrinsed eye
Hours after instillation 0.5 24 48 72
Cornea, whole area
no opacity 3/3 3/3 3/3 3/3
grade 1 opacity
grade 2 opacity
Iris function
not impaired 3/3 3/3 3/3 3/3
slightly impaired
Conjunctiva
Redness
no redness  3/3 1/3 2/3 3/3
grade 1 redness 2/3 1/3
grade 2 redness
Chemosis
no swelling 3/3 2/3 3/3 3/3

grade 1 swelling

1/3
Discharge
no secretion 3/3 3/3 3/3 3/3
very slight secretion
Total score 8
Average per animal 0.67

Table 2: Results.

Animal no. Findings 30 minutes 24 hours 48 hours 72 hours 10 days 14 days 21 days
no. 4 (male) Corneal density (A)* 0 0 0 0
Corneal area (B) 0 0 0 0
A×B×5= 0 0 0 0
Iris function and aspect (C)*  0 0 0 0
C×5= 0 0 0 0

Conjunctival secretion (D)

0 0 0 0
Conjunctival swelling (E)*  0 0 0 0
Conjunctival redness (F)* 0 0 0 0
(D+E+F)×2= 0 0 0 0
no. 5 (male) Corneal density (A)* 0 0 0 0
Corneal area (B) 0 0 0 0
A×B×5= 0 0 0 0
Iris function and aspect (C)*  0 0 0 0
C×5= 0 0 0 0
Conjunctival secretion (D) 0 0 0 0
Conjunctival swelling (E)*  0 1 0 0
Conjunctival redness (F)* 0 1 0 0
(D+E+F)×2= 0 4 0 0
no. 6 (male) Corneal density (A)* 0 0 0 0
Corneal area (B) 0 0 0 0
A×B×5= 0 0 0 0
Iris function and aspect (C)*  0 0 0 0
C×5= 0 0 0 0
Conjunctival secretion (D) 0 0 0 0
Conjunctival swelling (E)*  0 0 0 0
Conjunctival redness (F)* 0 1 1 0
(D+E+F)×2= 0 2 2 0
0 6 2 0

* used for calculation of eye irritation score.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC no. 1272/2008)
Conclusions:
The test item was found to be not irritating to the rabbit eye in vivo
Executive summary:

The eye irritation potential of the test item was evaluated in an in vivo experimental study equivalent to the OECD guideline 405 (1987). Three male rabbits were administered 100 mg of undiluted test item to the conjunctival sac of the right eye and not removed; the left eye served as a control. The eyes were evaluated for corneal opacity, iritis, conjunctival redness and chemosis at 30 minutes, 24, 48 and 72 hours after administration.

The corneal opacity and iritis scores were 0 in all animals at all time points. The mean (24/48/72 h) chemosis scores were 0 in animals #1 and #3, and 0.33 in animal #2. Mean (24/48/72 h) conjunctival redness scores were 0, 0.33 and 0.67 in animals #1, #2 and #3 respectively. All effects observed were fully reversible within the 7-day study period.