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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: The study was performed prior to the implementation of GLP and OECD Guidelines, but meets the principles of an eye irritation study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no details

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
2 males, initial weight 3.39 kg and 2.83 kg.
Source: Fa. Gaukler
no further details

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: NaCl-solution treated adjacent eye served as a control.
Amount / concentration applied:
ca. 0.05 ml or 60 mg undiluted test substance instilled into the conjunctival sac
Duration of treatment / exposure:
The eyes were not washed out after 24 hour.
Observation period (in vivo):
The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.
Number of animals or in vitro replicates:
2 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24h, 48h, 72h (mean)
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24h, 48h, 72h (mean)
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48h, 72h (mean)
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h (mean)
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h (mean)
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h (mean)
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
Details presented in the Table below. Irreversible damage has been shown in both treated rabbits.
Other effects:
Post exposure day 3: one rabbit with loss of appetite.
Weight loss was observed. The terminate weight was 2.9 kg (at the beginning 2.85 kg) and 3.47 kg (at the beginning 3.39 kg).

Any other information on results incl. tables

Eye irritation in rabbits after instillation of ca. 60 mg ethylene chlorohydrin

Time after instillation

Animal 1

Animal 2

1 hour

Slight redness, marked edema, opacity of the cornea and cornea exfoliated

 Slight redness, marked edema, opacity of the cornea with smeary overlay

1 day

Slight redness, marked edema, opacity of the cornea with smeary overlay

Slight redness, marked edema, opacity of the cornea and with smeary overlay

2 days

Slight edema; opacity of the cornea and with smeary overlay; nictating membrane whitish

Slight edema; opacity of the cornea and with smeary overlay

3 days

Slight edema; opacity of the cornea and with bloody & smeary overlay; nictating membrane partly whitish

Slight edema; opacity of the cornea  & smeary overlay; blood

6 days

Ulcerations, whitish nictating and mucous membrane with blood; corneal opacity; proliferation of blood vessels from the periphery

Slight edema; opacity of the cornea & smeary overlay; ablation of cornea; secretion; nictating membrane partly whitish

8 days

Iritis; crusty lids, scar formation; corneal opacity, smeary overlay & blood; proliferation of blood vessels from the periphery;

proliferation of blood vessels from the periphery; corneal opacity; blood

No effects were detected in the left eye treated with NaCl-solution (control)

Applicant's summary and conclusion

Conclusions:
Irreversible damage on the eyes in rabbits instilled with undiluted test substance.
Executive summary:

The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; 50 µl instead of 100 µl test substance instilled; scoring system not according to OECD405).

An amount of ca. 60 mg test substance was instilled into the right eye of rabbits; the left eye served as control (physiological saline instilled). No effects were detected in the control eyes but irreversible damage of the treated eye in both rabbits.

Conclusion: Irreversible damage on the eyes in rabbits instilled with undiluted test substance.

Conclusion: Irreversible damage on the eyes.