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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Disperse Red 073
IUPAC Name:
Disperse Red 073

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 single cages.
- Diet: a standard laboratory diet was provided ad libitum. The batch of the diet used for the study was analysed for chemical and microbiological contaminants.
- Water: ad libitum.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.
- Health check: prior to the test, the eyes of each rabbit were examined for pre~existing casual injury.

ENVIRONMENTAL CONDITIONS
- Temperature: the room temperature was maintained within a median of 23 ± 2°C recorded by a maximum-minimum thermometer.
- Humidity: 50 ± 10 % was measured by a hygrometer.
- Air changes: the rate of air exchange was maintained at approximately 15 changes/hour.
- Photoperiod: the light/dark cycle was 12 hours.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg of the test material was placed into the conjunctival sac of the right eyes of the animals.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Nine rabbits: three males and females unwashed eyes and three males whose eyes were washed.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: in three animals, the treated eye was rinsed with 20 ml lukewarm water.
- Time after start of exposure: after half a minute.

SCORING SYSTEM:
The eyes were inspected after 24, 48 and 72 hours. Reading score for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
unwashed eyes
Basis:
animal: 6/6
Time point:
24/48/72 h
Score:
< 1
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
unwashed eyes
Basis:
animal: 6/6
Time point:
24/48/72 h
Score:
< 1
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
unwashed eyes
Basis:
animal: 6/6
Time point:
24/48/72 h
Score:
< 2
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Remarks:
unwashed eyes
Basis:
animal: 6/6
Time point:
24/48/72 h
Score:
< 2
Reversibility:
fully reversible within: 72 hrs
Irritant / corrosive response data:
The irritation score resulted to be 0.67.
The substance can be considered as non irritating, according to the ETAD-Subcommittee for Toxicology.

Any other information on results incl. tables

Summary of eyes unwashed

Animal N. Reaction 24 hrs 48 hrs 72 hrs Mean 24/48/72 hrs
Male 201 Cornea opacity 0 0 0 0
Iris 0 0 0 0
Conjunctival swelling 0 0 0 0
Conjunctival redness 0 0 0 0
Male 202 Cornea opacity 0 0 0 0
Iris 0 0 0 0
Conjunctival swelling 0 0 0 0
Conjunctival redness 0 0 0 0
Male 203 Cornea opacity 0 0 0 0
Iris 0 0 0 0
Conjunctival swelling 1 0 0 0.33
Conjunctival redness 1 1 0 0.67
Male 204 Cornea opacity 0 0 0 0
Iris 0 0 0 0
Conjunctival swelling 0 0 0 0
Conjunctival redness 0 0 0 0
Male 205 Cornea opacity 0 0 0 0
Iris 0 0 0 0
Conjunctival swelling 0 0 0 0
Conjunctival redness 1 0 0 0.33
Male 206 Cornea opacity 0 0 0 0
Iris 0 0 0 0
Conjunctival swelling 0 0 0 0
Conjunctival redness 1 0 0 0.33

Eye unwashed

Animal N. Reaction 24 hrs 48 hrs 72 hrs
Male 201 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctival (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Male 202 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctival (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Male 203 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctival (D) secretion 1 0 0
(E) swelling 1 0 0
(F) redness 1 1 0
(D+E+F)x2 6 2 0
Male 204 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctival (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Male 205 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctival (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 1 0 0
(D+E+F)x2 2 0 0
Male 206 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctival (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 1 0 0
(D+E+F)x2 2 0 0

Eye washed

Animal N. Reaction 24 hrs 48 hrs 72 hrs
Male 207 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctival (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Male 208 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctival (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Male 209 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctival (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0

Applicant's summary and conclusion

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

Nine rabbits were used to test the eye irritation potential of the substance. 100 mg of the undiluted test material were placed into the conjunctival sac. The eyes were inspected after 30 minutes, 24, 48 and 72 hours. Reading scores for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).

The irritation score resulted to be 0.67. The substance can be considered as non irritating, according to the ETAD-Subcommittee for Toxicology.

Conclusion

Although the criteria for the evaluation of the eye irritation potential followed in the test are different from those reported into the OECD guideline, the scoring system is the same. Because the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC) No 1272/2008.

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 chemosis, in all the tested animals, thus the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.