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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978
Reference Type:
other: raw data related to study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: FDA guideline Vol 38. Nr 187, p 27019, 1973
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: Company guideline previous to OECD guideline implementation that is similar to OECD 405
Deviations:
not applicable
Principles of method if other than guideline:
Mucosal tolerance was assessed after single application of 100 mg test substance mixed with 0.05 ml Propanediol into the conjunctival sac of the left eye of six rabbits. The right eye remained untreated and served as a control. The experiment was conducted according to FDA directives (Federal Register Vol. 38, No 187, p 27019, 1973).
Evaluation was conducted 1, 7, 24, 48 and 72hrs after treatment by using a magnifying glass. 24hrs after treatment eyes were thoroughly washed with physiological sodium chloride solution. To assess the 48 and 72hrs time points a drop of a 0.01% sodium fluorescein solution was instilled into the eyes. Gradings of eye reactions were recorded according to Appraisal of the Safety of Chemicals in Foods, Drugs and Cometics, FDA, Austin, Texas, p. 51, 1975.
GLP compliance:
no
Remarks:
Performed prior to GLP implementation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Nako H (p-Phenylendiamin)

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
SPF-Albino-Himalayan-rabbit strain HOE: HIMK(SPFWiga).
Rabbits lived n sigle cages, Feeding was done with mix food ERKA8300 of Rpbert Koch oHG/Hamm and regular water- both ad libitum

Test system

Vehicle:
other: Propanediol
Controls:
other: the right eye remained untreated and served as control.
Amount / concentration applied:
A single dose of 100 mg substance (mixed with 0,05 ml Propanediol) was applied.
Duration of treatment / exposure:
The product was placed in the conjunctival sac of the left eye, the right eye remained untreated and served as control. 24 h after treatment eyes were rinsed with a physiological saline solution.
Observation period (in vivo):
examinations were done 1, 7, 24, 48 and 72 h after treatment
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
examinations were done 1, 7, 24 h, 48 h and 72 h after treatment
After checking at 24 h, all eyes were rinsed with physiological saline solution.
The check after 48 and 72 h was done after instillation of one drop of Fluroescein-Sodium in concentration 0.01 %
The numerical check was done with the classification mentioned in "appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, Austin, Texas, p 51, 1975

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: Animal # 320/321/322/324 each
Time point:
other: mean of 24, 48 and 72h
Score:
2
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: observation period was terminated before reversibility was evident
Irritation parameter:
cornea opacity score
Basis:
other: animal #323/325 each
Time point:
other: mean of 24, 48 and 72h
Score:
2.3
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: observation period was terminated before reversibility was evident
Irritation parameter:
iris score
Basis:
other: animal # 320/321/322/323/324/325 each
Time point:
other: mean of 24, 48 and 27h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: no signs of iris irritation during the entire observation period
Irritation parameter:
conjunctivae score
Basis:
other: animal # 320
Time point:
other: mean of 24, 48, and 72h
Score:
2.7
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: observation period was terminated before reversibility was evident
Irritation parameter:
conjunctivae score
Basis:
other: animal # 321
Time point:
other: mean of 24, 48, and 72h
Score:
3
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: observation period was terminated before reversibility was evident
Irritation parameter:
conjunctivae score
Basis:
other: animal # 322
Time point:
other: mean of 24, 48, and 72h
Score:
3
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: observation period was terminated before reversibility was evident
Irritation parameter:
conjunctivae score
Basis:
other: animal # 323
Time point:
other: mean of 24, 48, and 72h
Score:
2.3
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: observation period was terminated before reversibility was evident
Irritation parameter:
conjunctivae score
Basis:
other: animal # 324
Time point:
other: mean of 24, 48, and 72h
Score:
2
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: observation period was terminated before reversibility was evident
Irritation parameter:
conjunctivae score
Basis:
other: animal # 325
Time point:
other: mean of 24, 48, and 72h
Score:
2.3
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: observation period was terminated before reversibility was evident
Irritation parameter:
chemosis score
Basis:
other: animal # 320/321/323/324/325 each
Time point:
other: mean of 24, 48, and 72h
Score:
2.7
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: observation period was terminated before reversibility was evident
Irritation parameter:
chemosis score
Basis:
other: animal # 322
Time point:
other: mean of 24, 48, and 72h
Score:
2
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: observation period was terminated before reversibility was evident

Applicant's summary and conclusion

Interpretation of results:
other: Risk of serious damage to eye
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings under the conditions of this test the test substance carries the risk to cause a serious damage to eyes
Executive summary:

Nako H (p-Phenylendiamin) was tested for eye irritating properties according to a company guideline similar to OECD 405 and according to a FDA guideline (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). Following these protocol 100 mg of the test substance mixed with 0.05 ml Propanediol were placed in the conjunctival sac of the left eye of 6 Himalayan rabbits each. The right eye served as untreated control. 1, 7, 24, and 72 h after treatment eyes were examined. 24 h after treatment eyes were rinsed with a physiological saline solution. Mean scores (mean of 24, 48, and 72h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each rabbit.

Effects were not fully reversible within the observation period of 72h.

 

Mean scores of cornea and conjunctivae indicate that the substance is irritating to eyes. Since observation was terminated 72 h after treatment and before reversibility of effects was evident, irreversible effects have to be assumed.

Based on the findings under the conditions of this test the test substance carries the risk to cause a serious damage to eyes.