2-chloroethanol

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-chloroethanol

EC Number:

203-459-7

EC Name:

2-chloroethanol

Cas Number:

107-07-3

Molecular formula:

C2H5ClO

IUPAC Name:

2-chloroethan-1-ol

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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.