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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (no data on substance purity)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(Additional 3 animals were included in the test panel. The eyes of these 3 animals were rinsed)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
O-ethylhydroxylamine
EC Number:
402-030-3
EC Name:
O-ethylhydroxylamine
Cas Number:
624-86-2
Molecular formula:
C2 H7 N O
IUPAC Name:
O-ethylhydroxylamine
Details on test material:
- CTL reference number: Y05460/002/001
- Name of test substance as cited in document: Substance H109360
- Identification of test sample as stated in report: 50% (w/v) aqueous solution (approx. 46.4% ethoxyamine and approx. 5% ethanol)
- Appearance: clear aqueous solution
- Lot #: EFI-100
- Analytical purity: not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater Manchester, UK .
- Age at study initiation: no data
- Weight at study initiation: 2669-3245g
- Housing: singly in satinised aluminium sheet cages
- Diet: Labsure CRB Rabbit Diet provided ad libitum
- Water: via an automatic system provided ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16
- Humidity (%): 40-60
- Air changes (per hr): 20-30
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye (untreated)
Amount / concentration applied:
- Amount applied: 0.1 ml
Duration of treatment / exposure:
Eyes were washed in 3/6 animals 30-36 seconds after instillation. The eyes of the remaining 3 animals were not washed
Observation period (in vivo):
approximately 1 hour, 1, 2, 3 and 4 days after instillation, day 6 after instillation (only 3 animals), day 7 (only 4 animals)
Number of animals or in vitro replicates:
6
Details on study design:
The initial pain reaction of the first rabbit after treatment was moderate and the irritation was less than severe. The eyes of the remaining rabbits were
pretreated 3-4 minutes before instillation of the test sample with one drop of a local anaesthetic (OPHTHAINE, 0.5% proparacaine hydrochloride solution)

REMOVAL OF TEST SUBSTANCE
- Washing; yes, with 200-300 ml luke warm water for approx 2 min
- Time after start of exposure: 30-36 seconds
- Number of rabbits: 3

SCORING SYSTEM: Draize scale (Draize 1959)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
ca. 0.77
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual means of Animal # 1 = 1; Animal # 2 = 0.66; Animal # 3 = 0.66
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0.44
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual means of Animal # 1 = 0.33; Animal # 2 = 0.33; Animal # 3 = 0.66
Irritation parameter:
conjunctivae score
Remarks:
(washed eyes)
Basis:
mean
Remarks:
(of 3 animals)
Time point:
other: 24, 48 and 72 hours
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual means of Animal # 1 = 1; Animal # 2 = 1.67; Animal # 3 = 1.33
Irritation parameter:
chemosis score
Remarks:
(washed eyes)
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual means of Animal # 1 = 1.33; Animal # 2 = 1.0; Animal # 3 = 1.0
Irritation parameter:
cornea opacity score
Remarks:
(unwashed eyes)
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual means of Animal # 1 = 0.66; Animal # 2 = 0.33; Animal # 3 = 1.0
Irritation parameter:
iris score
Remarks:
(unwashed eyes)
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 h ours
Score:
0.44
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual means of Animal # 1 = 1; Animal # 2 = 0; Animal # 3 = 0.33
Irritation parameter:
conjunctivae score
Remarks:
(unwashed eyes)
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0.89
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual means of Animal # 1 = 1.0; Animal # 2 = 0.66; Animal # 3 = 1.0
Irritation parameter:
chemosis score
Remarks:
(unwashed eyes)
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0.73
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual means of Animal # 1 = 0.66; Animal # 2 = 1.0; Animal # 3 = 0.66
Other effects:
- Instillation of 0.1 ml of the test sample into the rabbit eye caused moderate initial pain in one rabbit. The eyes of the remaining five rabbits were pretreated with the local anaesthetic OPHTHAINE. One of these five rabbits had practically no initial pain, the remaining four showed no initial pain.

- Additional observations seen in all three animals whose eyes were washed included; epithelial erosion of the cornea, haemorrhagic nictitating membrane, haemorrhagic conjunctiva, convoluted eyelids, erythema of the upper and/or lower eyelid and Harderian discharge. All effects were reversible within 7 days.

Additional observations seen in animals whose eyes remained unwashed were convoluted eyelids (1/3 animals; reversible within 3 days), eye appeared cyanosed (2/3 animals; reversible within 7 days), erythema of the upper and/or lower eyelid (1/3 animals; not reversible within 6 days) and Harderian discharge (1/3 animals; reversible within 3 days)

Any other information on results incl. tables

.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test substance (Substance H109360) is considered to be irritating to the eyes.