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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study and guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984
Reference Type:
publication
Title:
Acute toxicologic evaluation of 4-aminodiphenylamine
Author:
Randall, D. J. and Bannister R.M.
Year:
1990
Bibliographic source:
Acute Toxicity Data 1: 63 - 64
Reference Type:
secondary source
Title:
Summary with cover letter dated 10/18/88; NTIS/OTS 516609, Doc I.D. 89-890000009 (1988)
Author:
EPA-OTS
Year:
1988
Bibliographic source:
Monsanto Co. (1984) Acute toxicity/irritation studies with 4-aminodiphenylamine (4-ADPA). Study BD-84-077 Summary with cover letter dated 10/18/88; NTIS/OTS 516609, Doc I.D. 89-890000009 (1988)

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EPA November 1982, section 81-4, pimary eye irritation study; TSCA EPA August 1982, acute exposure, pimary eye irritation
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(4-aminophenyl)aniline
EC Number:
202-951-9
EC Name:
N-(4-aminophenyl)aniline
Cas Number:
101-54-2
Molecular formula:
C12H12N2
IUPAC Name:
N1-phenylbenzene-1,4-diamine
Details on test material:
4-ADPA, purity 98.9 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
up tp 14 d
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Time point:
other: 24, 48, 72 h (mean)
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Time point:
other: 24, 48, 72 h (mean)
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: reversible
Other effects:
4-ADPA produced moderate but reversible ocular irritation in all animals. All six animals exhibited moderate to severe conjunctival irritation (redness, chemosis, discharge and/or necrosis), three exhibited corneal opacity and/or ulceration and one had iridial damage (at one hour only). Two animals were noted to have desquamation on the eyelids. All six animals were free of significant ocular irritation within 7 to 14 days after instillation of the test material.

Any other information on results incl. tables

RS-Freetext:
INDIVIDUAL SCORES (1, 24, 48, 72 h/animal)
- Cornea:   
    0, 0-1, 0-1, 0-1
    0,   1, 0-1, 0-1
  0-1,   2,   1, 0-1
    0, 0-1,   0, 0-1
  0-1, 0-1,   0,   0
  0-1, 0-1, 0-1,   0

- Iris:   
  0-1, 0-1,   0,   0
  0-1, 0,1, 0-1,   0
  0-1, 0-1, 0-1,   0
    1,   0,   0,   0
  0-1,   0,   0,   0
  0-1,   0,   0,   0

- Conjunctival redness:
    1,   2,   2,   2
    1,   3,   2,   2
    1,   3,   2,   2
    2,   2,   2,   2
    1,   2,   1,   1
    1,   2,   2,   1

- Conjunctival chemosis:
    3,   2,   1,   1
    3,   2,   1,   1
    3,   2,   1,   1
    3,   2,   2,   2
    2,   1,   1,   1
    2,   2,   1,   1

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information
Executive summary:

In a guideline study moderate ocular irritation from one hour to three days was noted in each of 6 rabbits after instillation of 0.1 ml of finely ground 4-ADPA into the conjunctival sac. Three animals exhibited corneal opacities or ulceration. All six animals were free of ocular effects within 7 to 14 days (Monsanto 1984).