2-Propyn-1-ol, compd. with 2-methyloxirane (1:?)

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: comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Golpanol PAP

IUPAC Name:

Golpanol PAP

Details on test material:

- Name of test material (as cited in study report): Golpanol PAP / 2-Propyn-1-ol, compd. with methyloxirane
- Physical state: liquid
- Analytical purity: approx. 50%
- Impurities (identity and concentrations): < 1% Propargyl alcohol, approx. 35% water, approx. 7% Propylene glycol, approx. 7% higher alcoxylated products

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Weight at study initiation: male (mean) = 3.02 Kg, female = 2.60 Kg
- Housing: stainless steel cages (40 x 51 cm) with wire mesh walk floors, one animal per cage, no bedding, saw-dust in waste trays
- Diet (e.g. ad libitum): 130g per animal per day
- Water (e.g. ad libitum): 250ml tap water per animal per day
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eyes of the same animals

Amount / concentration applied:

0.1 ml undiluted test substance

Duration of treatment / exposure:

single application

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3 (2 males, 1 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 21 days

SCORING SYSTEM: as described in test guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0.2

Reversibility:

not fully reversible within: 21 days in 1/3 animals

Remarks on result:

other: mean score 0.0 in 2/3 animals; mean score 0.7 in 1/3 animals

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0

Remarks on result:

other: no effects in 3/3 animals

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

1.6

Reversibility:

not fully reversible within: 21 days in 1/3 animals

Remarks on result:

other: mean score 2.0 in 1/3 animals; 1.0 in 1/3 animals; 1.7 in 1/3 animals

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0.4

Reversibility:

not fully reversible within: 21 days in 1/3 animals

Remarks on result:

other: mean score 0.0 in 2/3 animals; mean score 1.3 in 1/3 animals

Any other information on results incl. tables

The severity of substance induced eye effects was quantified for each time point using the following values:

Cornea/Opacity	Conjunctivae/ Redness	Iris	Chemosis/Swelling
0 = none	0 = normal	0 = normal	0 = none
1 = very slight	1 = slight	1 = circum-corneal injection	1 = very slight
2 = well-defined	2 = well-defined	2 = iritis	2 = well-defined
3 = moderate to severe	3 = severe		3 = moderate to severe
4 = severe to very severe			4 = severe to very severe

The irritation scores were calculated as mean of the single values of the time points 24 h, 48 h and 72 h and all three animals.

Cornea score/Opacity	0.2
Conjunctivae score/Redness	1.6
Iris score	0.0
Chemosis score/Swelling	0.4

One male animal showed contracted pupils starting 48 hours after application until day 21. Eight days after application of the test substance this animal also developed small retractions in the eyelid, loss of corneal tissue and suppuration. These effects persisted unchanged until day 21. Furthermore this animal showed marginal vascularization of the cornea on day 21 while the second male did not show any of these effects at any time point. The female developed loss of corneal tissue and contracted pupils only 48 hours after application of the test substance. These effects were fully reversible within 24 hours.

Based on the irreversible effects in one animal the test substance hold the risk of serious eye damage.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

irreversible eye effects, risk of serious damage to eyes