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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Preguideline study with limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Principles of method if other than guideline:
Draize Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diethylhydroxylamine #2049
- Analytical purity: no data
- Lot/batch No.: no data

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
No data available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
not rinsed
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
6
Details on study design:
One-tenth ml was placed in the conjunctival sac of one eye of each of six albino rabbits. The resulting reactions were scored periodically until recovery.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal: #animal 1 to 6
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal: #animal 1 to 6
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: #animal 1 to 6
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: #animal 1 to 6
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
The reaction was confined to moderate conjunctival inflammation which dissipated completely within 72 hours. None of the scores was positive at 24 or 48 hours and neither the cornea  nor the iris was effected.

Any other information on results incl. tables

Average scores were as follows:
----------------------------------------------------------
time        cornea          iris           conjunctival
                                    ----------------------  
                                    redness      chemosis
----------------------------------------------------------
10 mins       0               0        >1            1
1 hr          0               0         2            2
2 hrs         0               0         2           >2
3 hrs         0               0         2           >2
4 hrs         0               0         2            2
24 hrs        0               0         1            0
48 hrs        0               0         1            0 
72 hrs        0               0         0            0
----------------------------------------------------------

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU