Registration Dossier

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
Study period:
1987-09-01 until 1987-09-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

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:
IUCLID Test substance: as prescribed by 1.1 - 1.4
- Analytical purity: 99.5%

Test animals / tissue source

Species:
rabbit
Strain:
other: Small Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: singly in stainless steel cages
- Diet: diet K4, Ssniff Spezialfutter GmbH, Soest, Germany, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 hrs


IN-LIFE DATES: From: day 0 (initiation) To: day 21 after treatment

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to Draize (OECD 405)

TOOL USED TO ASSESS SCORE: fluorescein

EVALUATION:
1) Modified Maximum Average Score (MMAS) according to Draize (1944; cf. ECETOC (1998), company study T01716)
2) Average scores according to EU (79/831/EEC)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: MMAS
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, and 72 hrs
Score:
28.59
Max. score:
110
Reversibility:
fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hrs
Score:
1.44
Max. score:
4
Reversibility:
fully reversible within: 17 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hrs
Score:
0.89
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hrs
Score:
2.56
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hrs
Score:
0.78
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Single animal data are given below. For each score the data is given for the respective animal on reading at 24/48/72 hours after test material instillation (number in brackets indicates the time period within which the effect was fully reversible).

- Cornea score: animal #1: 2/2/2 (17 days); animal #2: 1/2/0; animal #3: 2/2/0
- Iris score: animal #1: 1/1/1 (21 d); animal #2: 1/1/1 (6 d); animal #3: 1/1/0
- Conjunctivae (redness) score: animal #1: 3/3/3 (21 d); animal #2: 3/2/2 (8 d); animal #3: 3/3/1 (6 d)
- Chemosis score: animal #1: 1/1/1 (8 d); animal #2: 1/1/0; animal #3: 1/1/0

Applicant's summary and conclusion

Interpretation of results:
other: Category 2 (irritating to eyes)
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
2-EH was markedly irritant to the rabbit's eye in a valid OECD 405 test. The effects were fully reversible within 21 days.
Executive summary:

2-EH was markedly irritant to the rabbit's eye in a valid OECD 405 test using 3 male Small russian rabbits. Reading for relevant effects were performed on 1, 24, 48 and 72 hours after instillation of 0.1 mL test material into the left conjunctival sac of each animal. Effects were observed for up to 21 days after instillation. Moderate corneal opacity was seen in all animals at 24 and 48 hours after treatment. The effect was absent in 2 animals at 72 hours after treatment and at 17 days in the third animal (mean animal #1: 2; animal #2: 1; animal #3: 1.3). Grade 1 iritis was noted in all animals. The effect was absent in two animals on day 6, and on day 21 in the third animal (mean animal #1: 1; animal #2: 1; animal #3: 0.67)

Moderate reddening of the conjunctivae was seen in all animals at 24 and 48 hours after treatment. Two animals were free of this effect on day 8, the third on day 21 (mean animal #1: 3; animal #2: 3; animal #3: 2.3). Chemosis was slight in two animals, and on day 8 all animals were free of this effect (mean animal #1: 1; animal #2: 0.67; animal #3: 0.67).

To conclude, 2-EH caused moderate eye irritation in all 3 treated animals. The effects were fully reversible within 21 days. The MMAS (Mean Modified Average Score) according to Draize was 28.59 (maximum possible score: 110).

The mean cornea score of all animals, the mean iris score of animal #1 and #2 and the mean conjunctivae score (reddening) of all animals exceeded slightly the EU criteria for classification as irritant category 2 according to Regulation (EC) no. 1272/2008 (H319). The mean conjunctivae score (reddening) of all animals was 2.56 and exceeded slightly the EU criterion for classification according to Directive 67/548/EEG (R36) (Hüls AG, 1987).