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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: comparable to guideline study with acceptable restrictions, Source substance for RA information according to analogue justification.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- 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

Resultsopen allclose all
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
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
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
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 GHS Criteria used for interpretation of results: EU
Conclusions:
irreversible eye effects, risk of serious damage to eyes
Executive summary:

A single application of 0.1 ml of the unchanged test substance was given into the conjunctival sac of the right eyelid of 3 white vienna rabbits without GLP compliance according to OECD 405 . Eye effects were documented 1 h, 24 h, 48 h, 72 h, 8 days, 15 days and 21 days after the application and the untreated eyes were used as negative control.

One male animal showed not reversible effects after 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.

Based on the irreversible effects in one animal the test substance hold the risk of serious eye damage and should be classified as eye irritating category 1 (GHS). (BASF, 1987).