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Eye irritation

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Administrative data

eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
The study predates the appropriate OECD test guideline and GLP. Although not in accordance with recent guideline (only 2 animals tested, of which one reveived an eye wash) the study is sufficient for assessment as the observations were severe enough for a classification as severe eye irritant (worst case outcome).

Data source

Reference Type:
study report
Report Date:

Materials and methods

Test guideline
no guideline followed
Principles of method if other than guideline:
0.1 mL of undiluted test material was instilled into the conjunctival sac of each of two albino rabbits. After 20 s, the treated eye of one animal was washed for 1 min. Following treatment for 4 h, the eye damage was examined.
GLP compliance:

Test material


Test animals / tissue source

not specified
Details on test animals or tissues and environmental conditions:
No details are given in the study report.

Test system

unchanged (no vehicle)
not required
Amount / concentration applied:
TEST MATERIAL- Amount applied: 0.1 mL
Duration of treatment / exposure:
4 h
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing: the eye of one animal was washed with tap water for 1 min- Time after start of exposure: 20 s after test material instillation SCORING SYSTEM: No scores were given in the study report.TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Remarks on result:
other: No scores were given in the study report.
Irritant / corrosive response data:
Animal 12101 (without washing): - Cornea: slight opacity, where seen, 1-4 h; slight generalised opacity with severe swelling 1-2 days; generalised opacity increasing from mild to moderate 3-14 days, swelling of cornea severe; extensive, very fine, dense superficial vascularisation penetrating into cornea by 14 days with an ulcer in the centre. At 21 days, pannus with some areas staining yellow (still active ulcer)- Iris: could not see 1-4 h; slight injection (no flare) 1 day; swelling and deepened folds (no redness) 2-3 days; could not see 7 days; moderate congestion 9 days; could not see 14 or 21 days- Conjunctivae (redness): severe blanching, mild redness 1-4 h; moderate with necrotic area and haemorrhage 1-3 days; severe to moderate 7, 9, and 14 days; moderate 21 days- Conjunctivae (swelling): severe 1 h-14 days; by 7 days there were adhesions of tissues and eye could not be opened. At 9 days using a local anesthetic and "Q-tips" these adhesions were separated, somewhat. Swelling remained severe but eye could be partly opened. Mild to moderate 21 days.Conjunctivae (discharge): copious 1-4 h; copious purulent, Hemastix positive 1 day; moderate purulent 3-7 days; moderate purulent (becoming bloody) 9 days; moderate purulent 14 days; mild purulent 21 daysAnimal 12102 (with washing): - Cornea: mild opacity. where seen 1-4 h; generalalised mild to moderate opacity with moderate to severe swelling 1-14 days; vascularisation began penetrating (shallow type) into cornea by 7 days with an area in central cornea staining yellow (an ulcer). By 14 and 21 days pannus over > 3/4 of cornea with active ulcer in center.- Iris: could not see 1-4 h; moderate congestion (no flare) 1 day; moderate congestion with flare 2-3 days; moderate congestion 7 days but too opaque to see a flare- Conjunctivae (redness): severe blanching with mild redness 1-4 h; moderate to severe 2-7 days; mild 14 and 21 days- Conjunctivae (swelling): severe 1 h-1 day; moderate 2-7 days; slight 14 and 21 days- Conjunctivae (discharge): copious 1-4 h; copious purulent 1-3 days; mild purulent 7 days; none 14 days; mild purulent 21 days

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS Category 1 (H318) according to Regulation (EC) No 1272/2008